Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Anyone have access to the 2/12 CVM story on Seeking Alpha? You have to be a Premium member to see it. If so, could you post it here?
Who needs the FDA?
Once UK gives the go ahead for conditional approval, were off to the races.
Europe will not stand by and watch its citizens cross the pond to get help.
When Europe gives the go ahead for their 140,000+ new cases each year, CVM will be maxed out on their capability to produce Multikine (20,000) till they build another facility. Depending on the agreements with UK and Europe, their looking at 1.5-2b yearly revenue.
2B in potential cancer drug sales is nothing to sneeze at and Big Pharma knows this. Especially with other cancers to follow.
There will be a buyout early on.
Doc, I think no one is willing to give them more then 1.70 till they can prove they have the goods to a regulatory body.
But here's my take on share impact.
As of today the website says they have 43,760,000 shares outstanding give or take a few 100k.
The new offering adds 794,117.
So were at 44,554,117 outstanding as far as I can ascertain.
The last 10Q said they have 1,103,070 outstanding warrants and options (excluding employee options).
So were at 45,657,187 total outstanding after this is done.
Possible add'l shares could be added based on the buyers prerogative.
This is an extremely low share count for any company. Seems lower then I've seen in the past due to warrant / option expirations.
In my opinion, this sale has very little impact on the company as a whole, since nothing has really changed, stock wise.
I'm jumping on the new price to add more, because IF they can just file a BLA or whatever Canada calls them, the stock should go back up nicely.
But man that is a BIG IF.
If my numbers are off, please feel free to jump in. I'm just a lowly coder.
When Geert, When???
Soon was months ago.
Institutional Investors Weigh In On CEL-SCI
Several institutional investors and hedge funds have recently made changes to their positions in the business.
Goldman Sachs Group Inc. increased its position in shares of CEL-SCI by 400.6% during the first quarter.
Swiss National Bank boosted its holdings in CEL-SCI by 7.4% in the first quarter.
Dimensional Fund Advisors LP lifted its holdings in shares of CEL-SCI by 338.3% in the first quarter.
XTX Topco Ltd bought a new position in shares of CEL-SCI in the first quarter valued at approximately $57,000.
Renaissance Technologies LLC purchased a new stake in shares of CEL-SCI during the first quarter valued at approximately $3,037,000.
CEL-SCI (NYSEAMERICAN:CVM) Receives Buy Rating from EF Hutton Acquisition Co. I
Feb 21st, 2023
https://www.etfdailynews.com/2023/02/21/cel-sci-nyseamericancvm-receives-buy-rating-from-ef-hutton-acquisition-co-i/
CVM is gearing up hiring for more manufacturing and distribution positions, a sign of big things to come.
Not looking like a company that foresees failure.
But seriously, I wish they would start making moves instead of all this SOON stuff.
9 Current Open Positions:
Quality Assurance Document Control (QA/DC) Assistant I
Facilities Engineer
Director of Quality Assurance
Validation Engineer
Manufacturing Support Technician
Manufacturing Process Technician
Human Resource (HR) Manager
Supervisor of Quality Control
Quality Assurance Auditor
Geert, help me understand.
You say approval is taking so long because:
1. Our treatment approach is new – no one has done this before.
We have to prove safety and efficacy.
Yeah, that was what the trial was for and you’ve had the data (proof) for over 17 months.
Why haven’t you put in your BLA application?
2. We also do not have the resources of Merck or BMS, and this contributes to the timing as well.
We’ve assembled an incredible bullpen of experts and the team is working 24/7 on the approval process for Multikine.
So what’s the problem? Is the bullpen not up to the task?
It’s been 17 months, why haven’t you put in your BLA application?
These esoteric excuses are not valid reasons after such a long time.
Is there an issue with your data and the FDA?
If so, you should let your long time investors know, so we can make proper investment decisions.
I think that’s a fair request.
Investor since 2009
God, I wish you were on to something, but I just can't see Geert letting this go for less then 12B. Then I can't see think of any buyout that took a under $3.5 stock to $200 -300. It would be historical to say the least.
It makes more sense that Frugal's idea that they are waiting on equipment to get the facility certified, so they can proceed to a Pre-BLA meeting.
Or they waiting on a peer-reviewed journal article as backup.
Whatever the case, Geert said he expected to file the BLA by end of year.
He better get a move on.
Great data info and pretty much the same we've been presented with in the last 3-5 months.
The question is, has this been presented to the FDA for permission to submit a BLA?
If not, Why?
If so, what did they say?
Pretty much that is all that matters at this point.
After 30 years, you'd think there'd be a bit more urgency.
My only guess is they are waiting for a peer review article in a medical journal based on advise from their paid FDA experts.
If this is the case, it doesn't show a wealth of confidence in their trial data.
I know I'm wavering a bit.
So what is coming first? Journal Article or Pre-BLA meeting?
I just hope Geert isn't waiting on an article before setting up the meeting.
That could delay everything for weeks, if not months.
A poster from another board put out (I’m paraphrasing) there will be no significant price movement till 1 of 3 things happen:
1. Approval
2. Buyout
3. FDA request a new round of test
I basically agree, but there are other events that can affect price, related to these.
1. Approval
Before approval, there has to be a positive Pre-BLA meeting.
You’ll know it was positive if CVM says there are submitting a BLA application.
This means the FDA gave a green light to submit the application and will give it serious consideration. Many buyout offers happen once this occurs.
Big Pharma (BP) loves the press they get in having a new drug in the pipeline that has a great chance to be approved.
Also a major medical peer review article could move the needle as well, though not as much, as the shorted Hedge Funds (HF) will beat it back down over time with negative articles and paid bashers. God knows we have a few on this site.
2. Buyout
If no buyout comes before the BLA application is submitted then CVM is on the clock.
BP and HFs must decide do they want to make offers and close out short positions or go back to the age old playbook of using inside contacts at the FDA to stop/delay approval. See the DNDN story – I know broken record, but it’s real and can happen to CVM.
I just don’t believe BP will take a chance on an upstart company grabbing SOC oncology revenue, eating into their profits.
Which leads me to:
3. FDA request a new round of test
This is what scares me most. The FDA is notorious for asking small pharmas to prove what’s already been proven. This rarely happens to Big Pharma.
If the FDA requests another battery of test, CVM is in a boat load of trouble. Even if they can pull together another clinical test, it will devastate them finically and delay approval for at least 2 years. Oh the Horror.
I’m sure I missed a few other SP movers, but these are the ones that come to mind.
Comment if you like, except for the paid bashers I pertained to earlier.
I already have you on ignore.
A recent Seeking Alpha report from yesterday
CEL-SCI says neoadjuvant multikine shows response in head/neck cancer in trial
* CEL-SCI (NYSE:CVM) reported data from a phase 3 trial of neoadjuvant multikine in patients with newly diagnosed locally advanced squamous cell carcinoma of the head and neck at the European Society for Medical Oncology (EMSO) annual Congress in Paris, France.
* In the IT-MATTERS study, early tumor response (early response) to neoadjuvant multikine-treatment was seen before surgery (occurring at median 5 weeks post-randomization) adding credibility to the isolated impact of early treatment, the company said in a Sept. 12 press release.
* CEL-SCI added that early response was noted only in the multikine (Leukocyte Interleukin injection) treatment groups and not in the control group.
* Early response occurs in both the lower risk and higher risk groups for recurrence, the company noted.
Pretty much a rehash from the posters, but always good to get more exposure.
Here are the ESMO 2022 Posters.
The second one is a little beyond my pay grade, maybe some of you can comment.
But the first one has pictures of before Multikine and after. It’s not hard to see the amazing improvement in these poor patients tongues in just three weeks.
I showed my skeptical girlfriend and even she was awed by the pics.
I hope I never get this terrible disease but if I do, I hope even more that this treatment is available.
https://cel-sci.com/wp-content/uploads/2022/09/CEL-SCI-ESMO-690P-Early-Responders-Poster-FINAL.pdf
https://cel-sci.com/wp-content/uploads/2022/09/CEL-SCI-ESMO-128P-HP-Poster-FINAL.pdf
This is very encouraging as H&N cancer is life-threatening or severely debilitating.
During a meeting in March, FDA advisers found that data from Amylyx’s relatively small initial trial was insufficient to prove that AMX0035 slowed ALS progression. The negative decision put the FDA in a bind, as the agency, under pressure from disease activists, has promised to exercise flexibility in approving drugs for dire illnesses such as ALS, given the urgent need for better treatments.
Broadest Flexibility
The agency has determined that it is appropriate to exercise “the broadest flexibility” in applying the statuary standards, he said. “The procedures reflect the recognition that physicians and patients are generally willing to accept greater risks or side effects from products that treat life-threatening or severely debilitating illnesses than they would from products that treat less serious illnesses.”
So CVM had a huge trial sample, no side effects and meets all the flexibility parameters. It would be hard for the FDA to approve this drug on such flimsy data and reject Multikine.
Also CVM would be prudent to start enlisting H&N doctors who are favorable to their treatment to act as activists in contacting the FDA.
The Keytruda comparison is not only valid it gives the road map to CVM to get multiple cancers approved.
I said as much in post 41106.
The data, for low risk H&N cancer group is irrefutable and should be approved in short order.
I’m guessing (hoping) at an October Pre-BLA meeting. Approval 3-6 months after that.
Multinkine’s valuation is seen in the 21B buyout of Immunomedics in 2020 by Gilead Sciences to get its hands on the newly approved chemo cancer drug Trodelvy. Trodelvy, which is sold as a triple-negative breast cancer drug in the US and other markets and for urothelial cancer in the US, brought in $146 million in revenues in Q1 2022, about 600 – 700M a year with growth.
Multikine as SOC, should pull in 1B the first year and 2B once acceptance is established, using current manufacturing capacity. Any further manufacturing expansion or cancer approvals just make the billions grow.
The only fly in the ointment is the FDA, whom I do not trust.
If there is any hint of FDA regulators giving CVM more hoops to jump though (see the DNDN story) due to outside influences such hedge funds with millions in shorted stock. Or Big Pharma protecting their cancer drugs against competition, you don’t need recurrent cancer drugs (Keytruda) if you’re basically cured.
Only time will tell, but we are definitely getting closer to the end of this story.
So I'm really hoping they have already requested a meeting, possibly in August.
They did say they have been talking to the FDA.
To listen to Geert they plan on submitting the BLA in 2022.
From a previous post of mine:
'After the meeting has been requested, the FDA will respond to a Type B meeting request within 21 days.' AND ‘ The FDA intends to schedule all Type B meetings to occur within 60 days of receiving the written meeting request.’
In order to make the end of the year, while addressing any of the FDA’s concerns, I think they need this meeting in mid-October.
So the Clinical Study Report, which I assume is submitted to the FDA for a meeting request, should be either done by now or damn near to it. They've had the data for over a year and nothing has changed.
According to Geert, they are working hard everyday to get this approved.
The Clinical Study Report for FDA Submissions should have been one of those 'To Do List' items early on.
If they haven't requested a meeting, what could they be waiting for?
What catalyst do they think the FDA will go, "Oh This Changes Everything", lets get this approved?
The Pre-BLA meeting is a type B FDA meeting.
According to this site:
https://www.propharmagroup.com/blog/formal-meetings-fda-sponsors-applicants-pdufa-products/
Except in the most unusual circumstances, the FDA states that it will honor most Type B meeting requests. The FDA intends to schedule all Type B meetings to occur within 60 days of receiving the written meeting request.
Sponsors should be proactive in crafting meeting request letters that justify the need for a face-to-face meeting. The meeting request “should include enough information for the FDA to assess the potential utility of the meeting and to identify the FDA staff necessary to discuss proposed agenda items.”
After the meeting has been requested, the FDA will respond to a Type B meeting request within 21 days. At this point, the Agency will either grant or deny the Sponsor’s request. If the meeting is denied, the notification will include an explanation as to why the meeting was denied. Any denial that is made “will be based on a substantive reason, not merely on the absence of a minor element of the meeting request or meeting package items.”
If a meeting is granted, CBER or CDER will notify the Sponsor of its decision and the meeting will be scheduled by determining the meeting type, date, time, length, place, and expected FDA participants.
That’s truly the exciting part.
Once Multikine is being used for H&N tumors and Oncology doctors are hearing stories of tumor shrinkage and full recovery, they’ll have to think: I wonder if this will work on my Skin, Lung, Breast, etc. Squamous Cell Carcinoma cancer patient.
Since it has zero toxicity, nothing to lose rich patients will give it try, on their Doctors suggestion using their own funds for off label. These are your best test subjects because all successes will be tweeted and word spread fast as a miracle cure. It’s only a matter of time before demand forces the FDA’s hand in approving other cancers. They’ll use biomarkers, like with Keytruda, to get the drug approved faster.
That’s when, Geert’s dream of being the highest Pharma Buyout offer in history will come to fruitarian.
But as the Doc said, first FDA H&N approval.
CVM is combating the same miscreant bias Hedge Funds, MS media, FDA MD‘s and Politicians that DNDN (Dendreon) did.
This slime, using naked shorting, was able to delay FDA approval for two years, while false claims about the data was the churned out daily.
To DNDN’s credit they did persist in getting approval, no small feat when you’re up against such a formidable force. But, they still fumbled the ball on the 1 yard line through self inflicted wounds.
1. They did not put into place a large and efficient enough manufacturing capability, so they could meet the public’s needs and make a sufficient revenue stream.
2. Because of the small revenue stream, they jacked up the price which brought Medicare scrutiny and denials which scared doctors into not prescribing their treatment.
3. They did not work with Medicare up front to come up with a planned path for patients to receive the drug and have it reimbursed. Medicare would of told them how much to charge to avoid denials. Higher prices will follow once overall acceptance is established.
They had other issues as well, but in the end, they could not provide this treatment at a profit and they went bankrupt. Bankrupt with a novel FDA approved immunology drug! Astonishing.
So CVM first must use all its will to get this over the finish line. The same cast of greedy a-holes are using the same playbook and possibly only bringing on a larger, more connected partner may be the answer.
Either way, once they get approved, DNDN shows them exactly what NOT to do.
From the data, what was shocking, was there were only 2 participants from the US and 3 from Canada. For some reason I thought the US was a large part of this study.
Russia, Serbia and Ukraine made up the largest portion of study.
Not sure how that will play into approval, if any, but it surprised me.
First, thank you Conix for responding to a conversation about CVM and it's path to success vs constant 1 - 2 lines responding to nonsense by posters paid to say unsupported negative views.
To your point, I truly don't know. If you look at history, the FDA will approve this drug, though I'm sure not as fast as we like. I've never understood the 'Market' and why it moves the way it does.
But, why a Pharma company that needs a big win doesn't come in now and beat the competition before the price is jacked up by approval, is beyond me. Possibly they are waiting for the 'Market' to beat CVM down and force a cheap buyout. I think Geert will go it alone before he gives away his baby.
Geert Kersten tweeted this:
·
7h
$CVM We persisted when experts told us that cancer immunotherapy would not work, that head & neck cancer was an impossible to treat disease, yet we have an almost 4 yr survival benefit for patients receiving our Multikine plus surgery and radiation.
https://twitter.com/geertkersten1?lang=en
Thank You God.
Finally another step closer to FDA approval.
I thought they'd (Big Pharma) never let this get moved forward.
It will be the end of Chemo once this starts healing people and people realize they have an alternative.
https://www.clinicaltrials.gov/ct2/show/results/NCT01265849?term=multikine&draw=2
Now the question is
'Do we have to wait for a Journal Review before going to the FDA for approval?'
I really don't know. It seems that this step takes forever and CVM will be at the mercy of the journal(s).
Thoughts?
Well I called this one. They waited a full 29 days to make a request that could be fixed in under a day.
There is nothing about this data review process that is remotely competent and most likely corrupt.
They'll probably wait another 29 days and just to show everyone how much power they have and unaccountability, they'll request another update.
Once ClinicalTrials.gov get done dragging out the approval for as long as they like, the FDA will get their turn. And it will not be pretty.
But hey, what's it matter that H&N patients are delayed in getting this life saving drug,
At least, all the Big Pharma marching orders were followed.
Yeah, I'm pissed off.
Excellent Post. So how in the world does this online report
Most Promising Oncological Drugs Expected to Launch in 2022
https://www.delveinsight.com/blog/oncological-drugs-to-be-launch-in-2022 site
not even mention Cel-Sci?
Not even as an also-ran.
I read about most of the other drugs and none even come close to the results Multikine demonstrated. Talk about being blacklisted.
Now on this site:
Top 20 Oncology Companies Based on 2020 Oncology Segment Revenue
https://pharmashots.com/5264/top-20-oncology-companies-based-on-2020-oncology-segment-revenue
We can see 5 to 6 companies that make less then 2B a year in Oncology.
Roughly Cel-Sci projected revenue the first year.
These companies should be banging on Cel-Sci's door to get on the ground floor.
Bayer $1.68B
Sanofi $0.97B
Gilead Sciences $0.67B
GlaxoSmithKline $0.51B
Also some of the heavy hitters will be running into patent expirations.
I just don't understand how Pharma decides who to buy when it comes to pipelines. Throw 15-20B Cel-Sci's way, help them get over the finish line and then 5-6 other cancer using Merck's roadmap using bio-markers.
To me, it's a no brainer. You'll get your return in a several years and control SOC for many more years.
CEL-SCI Appoints Dr. Gail Naughton to Its Board of Directors
"A highly accomplished visionary in biotechnology, Dr. Naughton has brought several FDA approved products to market, and we are very pleased to welcome her to our board. Her unparalleled expertise will be very helpful to CEL-SCI," stated CEL-SCI CEO Geert Kersten.
Dr. Naughton commented, "Based on the results of the largest study of its kind, Multikine can significantly improve outcomes for patients with newly diagnosed head and neck cancer. CEL-SCI’s management team and board have been tenacious in advancing an immune therapy that can have the greatest beneficial impact on patients—when they are first diagnosed with cancer. I look forward to contributing my guidance as the company transitions through regulatory approval and into delivering treatments that can help extend patient lives."
This is great news, it shows CVM is honing their goals to Approval and Marketing if no Buy Out is acceptable.
So ClinicalTrials.gov “… will post publicly clinical trial results information on ClinicalTrials.gov not later than 30 calendar daysafter the date of submission.”
That means come Thursday the 18th either we will have to submit another update and wait 30 additional days (highly likely, I'm a believer in the the Big Pharma / Fed Gov't connection) OR we will we finally see CVM data posted.
Possibly a Journal Review article shortly after.
Anybody (aside from the 3-4 naysayers I've had blocked for quite sometime) have a
guess? Or better yet some inside info?
This is an excellent post and I've said as much in many of my post in the past.
But just so were all on the same page as to stock count, as of last reports:
Outstanding 43,328,104
Warrants and Options 14,295,501
Total 57,623,605
Warrants and Options are subject to expiration, but if a buyout happens, expect the outstanding ones to be exercised.
But still the stock price is practically the same and long-timers will finally be rewarded.
Well based on current events, ClinicalTrials.gov should be sending a new request for another format change (please make this section blue) around Aug. 15th, pushing data posting a full 6 months.
Nothing suspicious about that.
Dr. totally agree. Here is a life saving drug and these bureaucrats are fixated on format. They have no problem delaying its approval by months. Every new request takes a month to return even if it's a minor detail.
Someone needs to fix this process, so small pharma is bled dry by unnecessary and in my opinion, questionable request.
My guess, job security, no point in reviewers if they don't find issues.
Q Thank You for that link to Reddit AMA.
It was very informative and more of Geert's mindset and plan forward then anything I've heard or read thus far.
It gives me a bit more hope that I will not have to wait past end of year for an FDA submittal, but hope does not pay the bills.
I will say, if the FDA does give CVM the go ahead to submit, then approval is a done deal and offers will start coming in. Even faster if they get Accelerated status.
What Geert is willing to accept is still a mystery.
I'm hoping for a 12b or greater buyout.
If Geert pulls off a 15b - 20b offer as you've suggested, I'm going to Disney World, IN PARIS!
Steve, I'm in the same boat as you are, been in since 2009.
I hope your wrong.
Geert seems sincere when he discusses the drug's benefits for H&N patients.
Now that the Clinical Trials site has returned results (July 14th), if there is no resubmittal, I expect things to move along.
The FDA meeting needs to be scheduled ASAP, peer review or not.
Any more non-progress would support your theory, money has a way of corrupting even the most benevolent.
Do we know how many of the 'In the Money' warrants were exercised from the last several weeks?
Chances ClinicalTrials.gov ask for a new submission?
I give 50%.
Chances publication in peer reviewed journal in August?
10%
September
20%
2022
50%
FDA Submission by End of Year
10%
Just going off past events.
I still believe, just pissed off at how long this is all taking.
A recent article put these out:
Multikine Near Term Milestones
? Submission of data of clinicaltrials.gov – May 2022
? Presentation of abstract at ASCO – June 2022
? Development of clinical study report – 2022
? Request meeting with FDA to determine path forward – 2022
? Development of paper for publication in peer reviewed journal – 2022
? Presentation of data package to review with FDA – 2022
? Address FDA Comments – 2022
? Submission of BLA to FDA – 2022
The question is can CVM accomplish these milestones by end of year.
I hope so, but past experience says no.
It took them 9 months to submit the data to clinicaltrials.gov. 9 months and they still have to resubmit it twice, if not more.
I’m definitely on the outside looking-in, so they may be working at breakneck speed with perfect execution and I just don’t understand.
But as an investor of over 10 years, going thru two reverse splits and taking tons of flack from family members for investing in this company, my patience has now turned into nerves of steel and their wavering.
CVM says it has funds thru 2023, a lot of it came from my retirement, so no, they don’t need more money or dilution.
They need a quick kick in the pants.
The 333,432 warrants that expire on June 22 are interesting. They are in the money, but will they be exercised? They are the largest lot from your list. Same for the ones expiring June 30th.
I’m guessing the 120k at $9.25 expiring on July 13th and 26k at $12 expiring on August 15th will expire unless the FDA offers CVM an expedited approval.
The more that expire the better, less dilution.
"CEL-SCI intends to file a BLA with the FDA for approval."
So what are they waiting for?
They've had the data for going on a year now, they have FDA people consulting, and they've done ASCO. Supposedly, the data is irrefutable.
These applications should have been done months ago and ready to submit.
Do they have to wait till the data is posted on ClinicalTrials.gov?
Do they have to wait till a medical journal decides to do an article?
If so, we are screwed, cause these journals report to higher powers.
Do they have to beg the FDA for a pre-BLA meeting first? Again, higher powers.
As an investor I just want to know why the word 'intends' is being used.
It's not like they haven't been INTENDING to do this for years.
How about 'By End of Month, or 'Next Week' or better yet 'Tomorrow'.
It's just so frustrating to see them act as if they're in no big hurry after so many years.
Bristol Myers expects Repotrectinib to be approved in the United States in the second half of 2023??
From my reading, they are still in Phase 2 recruiting, with 6 variations of cancer testing.
How could they get through Phase 2, approved, start Phase 3 and get approved in a year and a half?
https://www.onclive.com/view/fda-grants-breakthrough-designation-to-repotrectinib-for-pretreated-ros1-metastatic-nsclc
Is it the Breakthrough designation?
How long did CVM take? 10 years, give a take a few years.
If so, why didn't we get this designation?
Is this cancer any deadlier then H&N?
Is the science behind Multikine any less ground breaking?
If they get approved in 2023 or even 2024, that just proves the FDA 's favoritism to big Pharma.
FDA Approved: Yes (First approved March 21, 2014) Brand name: Otezla)
https://www.drugs.com/history/otezla.html#:~:text=FDA%20Approved%3A%20Yes%20%28First%20approved%20March%2021%2C%202014%29,psoriasis%2C%20and%20oral%20ulcers%20associated%20with%20Beh%C3%A7et%E2%80%99s%20Disease.