I Am Geert R. Kersten. I have been working in Cancer Immunotherapy for over 3 decades & am CEO of CEL-SCI Corporation. I'm here to talk about CEL-SCI and our investigational therapy Multikine which recently completed its pivotal Phase 3 clinic...

When you release data, will it be complete analysis or top line ?

complete analysis

As a follow up - Why wait for all of the analysis to be complete when more often than not companies release top-line results followed up by secondaries/complete analysis months later? Logically waiting for the complete analysis to be complete will only further delay any news.

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Thanks in Advance

Our people want a complete analysis because Multikine is a completely new way of treating cancer. A first in a new class of drugs. We will always err on the side of being conservative.

How COVID impacted the flow of Phase 3 clinical trial?
How COVID impacted the company and its employees in general?

COVID has had an impact on everything. As one very experienced man said: Thank God that we are done with the study. We did not apply for a PPP loan because we had enough money and did not want to take money from small businesses. We have had no layoffs. In fact we hired more employees and plan to hire more in the future.

Have there been any big pharma expressing interest in cvm either for a partnership or acquisition contingent on data?

No comment

During 2020 you added four job postings. Were any of them fulfilled?

If no, what's the reason for that?
If yes, why the job postings are still on the website?

We are still looking for new employees.

DIPG is a fatal brainstem tumor found mostly in children. Will this therapy be a potential treatment for DIPG? These kids are given 9-18 months to live. Some less, my daughter got just under 7 months. There is no treatment for DIPG, and it is too late for us, but it would be amazing to finally find a treatment for this horrific cancer. Thank you

It sounds terrible. My heart goes out to you. We have no information on this at all. I wish you and your daughter all the best.

Could Mulitkine be effective on other cancers besides head and neck cancer, and when might it be available to the general public? Is it available to patients as an investigational drug currently?

Thank you for working on your cancer treatment.

First we must prove it to work in head and neck cancer. Then we can develop it for other cancers since Multikine is an immunotherapy which is not cancer specific.

Hello - long time investor here, and I'm a bone cancer surgeon.

Have you compared the average length of survival of all the patients in your study? (if the average is longer than expected, then the drug is likely working).

I remember reading that in CVMs Stage1 and 2 clinical trials, there were some complete mass resolutions, and significant shrinkage of several tumors.

Has this also happened in the stage III trials? If not, why do you think so?

Estimated cost for drug treatment?

I suspect this will have significant off label use. I've love to use it on my sarcoma pts, and pts with metastatic spread of carcinomas. DO you think ins companies will pay for treatment?

thank you for your time.

As a surgeon you know how terrible this disease is. The study was expected to have reached 298 deaths about 2.5 years ago. An analysis of how these patients have been doing during the time of the study (SEER database) show that there has not been an improvement in the treatment of the specific type of patients we are enrolling. We do not know the price yet.
Average time in the study about 5 years.

I dont understand this stuff very well, are you saying you have not seen an improvement in lifespans? Ie, you havsnt seen an increase in survival? Im so sorry if i completely misinterpreted that...

We have to wait for the final results to prove a survival benefit.

What is the method or action that makes Multikine different from other treatments?

MoA – Multikine (MK) is a mixture of Pro-inflammatory Cytokines designed to create a change in the immune cells that infiltrate the Tumor microenvironment and kill the tumor. The Cytokine mixture also has cytokines (like TNF-alfa) that directly kill tumor cells. MK is thus (1) actively kill tumor cells, and (2) activates an anti-tumor specific immune response to attack and kill the tumor. All in essentially non-toxic manner.

Other anti-cancer therapies (e.g., Chemotherapy, monoclonal Antibodies (mABs), Checkpoint Inhibitors) are (a) Toxic and cause both tumor and non-tumor cell death and are non-specific (Chemotherapy, mABs) or (b) are directed to the tumor (Checkpoint Inhibitors and other monoclonal anti-tumor antibody treatments) but also can interact with other cells that have the same receptors on them thus causing non-specific damage and greater toxicity.

Nothing but respect Geert, no matter when the data comes we have the conviction that it will be beyond positive. The question is where would you retire ? Tampa maybe? If so I need to invite you a beer ! Salud and congrats things are about to be really good ... we believe !

Retire??? Really??? Retirement was invented by Bismarck to make room for the young folks.

Is that a yes on the beer ?

absolutely

Geert did you receive the cvm stickers I sent you? Keep up the great work.

I did. Thank you. It really does take a village.

Can you elaborate on the different roles Ergomed and ICON have in the phase 3 trial?

Ergomed is responsible for the management of the sites and ICON is responsible for data management.

Do you feel current cash on hand is enough to get thru until data release?

We have the best balance sheet in 9 years. It should be good.

Why are the shorts so confident that the trial failed years ago?

I do not know that they are confident. We believe that we will be successful. The outcome will be determined by one thing only: data

What was CEL-SCI's estimate for drop out % for the phase 3 trial?

We do not know. We are blinded. However, if there was a drop out problem, the IDMC who sees everything is supposed to tell us. They did not do so.

Additional information about us.

CEL-SCI Corporation is based in the Washington, DC region with 3 facilities: an office, a lab and a manufacturing facility. The stock is listed on the NYSE American: CVM.

We have developed a completely novel experimental cancer drug called Multikine which is at the end of a huge Phase 3 clinical trial to prove its safety and effectiveness. Multikine uses our immune system to fight the tumor; and we have not seen any major toxicities in our studies so far. In fact, it appears to improve the patient’s quality of life. Multikine is composed of a mixture of cytokines and chemokines that we all produce. It mobilizes the patient’s own immune system to fight his/her tumor. Our goal is to use Multikine to change the way we treat cancer. Many cancer patients are diagnosed with a cancer that is deemed curable. The first treatment regimen is some combination of surgery, radiation and chemotherapy. These are ”intent to cure” treatments. Unfortunately, we all know too many people whose cancer recurred. The bulk of normal drug development focuses on those people.

We administer our immunotherapy right after diagnosis, BEFORE surgery, radiation and chemotherapy because that is the time when the immune system is still strongest, thereby giving the patient the best chance for a positive outcome. Our study was supposed to have finished several years ago, but the patients in our study died much more slowly than had been expected. We think that could be a very good thing. A review of all of the factors that could play a role in the patients in our study living longer leaves us with the belief that the Phase 3 study may be repeating the positive results seen in our the earlier Phase 2 study. In that study Multikine treated patients lived significantly longer than would have been expected based on reported results in the literature for matched controls. Also, in some patients whose tumors were removed at surgery no tumor cells were observed, after only 3 weeks. And, the independent review committee whose job is to review the study in detail (the IDMC) with all of the information available to them told us to continue the study even as recently as April 2020. IDMC’s are supposed to tell a company when the study is not likely to be successful. Pfizer alone had 2 major studies shut down by an IDMC in 2020.

The Multikine study ended when 298 events (deaths) occurred in late April. Now the organizations (CROs) that have been running our Phase 3 trial are engaged in data lock (a review of all data in the past 9.5 years) and analysis of the data. Since we are blinded to all patient data we are not directly involved in these matters. The study managers, physicians and scientists charged with these responsibilities are very experienced and competent and have proven themselves in the past. We have to wait for them to finish their work! Once we are told the results we will announce them to the shareholders as required by SEC regulations. In the meantime we are expanding the manufacturing facility in Maryland in expectation of a successful outcome.

We believe that we will be successful in creating a new way of treating cancer, hopefully one with the toxicities we are used to seeing from cancer drugs. If we are successful one would expect Multikine to become part of a new standard of care to be given as the first treatment following diagnosis for the treatment of advanced primary head and neck cancer patients. That market represents about 450,000 patients per year. There have been no significant advances in treatment of this disease in the past fifty years. This is truly a dread disease with an unmet medical need. If our trial is successful, as we believe it will be, this would constitute a major advance in the treatment of this disease. Other cancers for which Multikine treatment may be useful are cervical, melanoma and breast cancer.

I’d like to be considered for a position in Multikine sales upon approval. How would I apply?

Let us wait a bit. Then call us.

Geert, hugely appreciate your straight shooting over the years and I am amazed at your fantastic progress. I assume COVID has added delays to the data lock, analysis phase. Would you say those delays have been major (months) minor (weeks) or really had no significant impact on the time to complete the lock and analysis?

Since we are not involved in the details of this process, we are unable to tell the extent of the delays. However, almost everything we see is delayed these days.

Despite this, you must be in constant contact with the CRO, as most management teams are with theirs that allow them to guide the street to a Q3 or Q4 release, for instance. Since you will wait for full data release (vs. just topline), could a delay until 2021 be in the cards? Or can you guess that it would come before year end?

We only issue guidance when are are in control and sure about the guidance. Therefore I will not say more.

Hi Geert, where is your head state/mind space in right now? The next few months must be a very anxious and critical point in your life for the better or worse. Nice spice of life?

After all of the nonsense we have had to deal with and the successful resolution in favor of CEL-SCI in all cases, we believe and feel quite relaxed.

There a large number of exciting intratumorally injected I/O therapeutics on the pipelines of many major pharma companies. One problem with locally administered therapeutics is the issue of missing metastatic tumors or micrometastases that cannot be detected. What are your thoughts on the feasibility of these intratumoral therapies?

Also, do you have quality control/manufacturability issues with multikine? Do you have to screen every batch to confirm cytokine ratios? Do you culture your cells with FBS? If so, do you have a process to remove the FBS from your final injection, or is the FDA okay with bovine excipients in your injection?

We developed and validated the manufacturing before the Phase 3 started.
I do not know of any cancer therapy that can be placed ahead of the intent to cure surgery, except for Multikine, since a delay in surgery is not permitted. That is why we give Multikine for only 3 weeks in our Phase 3 trial.

Will you design some Multikine short shorts if all goes well? Also, will they be offered at a reasonable price since many wearers will likely be broke?

Elon Musk is sooo good. We cannot compete with him.

Could you tell us the date that the study reached data lock?

we will only announce the final data.

Not related to cancer but my wife has Immune Deficiency that requires an IVIG treatment every 4 weeks. Do you see any advances in immunotherapy that will result in her being able to no longer need IVIG treatment in the future?

I am very sorry to hear that. One of our neighbors has something similar. I do not follow that field.

Hi Mr. Kersten

Could you clarify how many teams will be doing data analysis. In one of your interviews it sounded like there might be 2 teams, the CRO and an independent team or is it there is an independent team assisting the CRO? Thank you and best wishes!

Ergomed and ICON plus outside experts. Whatever it takes to get it done right and as fast as possible.

So what's your plan with who sees data right away when you get it? Will it be a small group looking it over together? Just you first? With so much riding on this I'm fascinated with picturing how it will go down at CEL-SCI.

After we get the data, we will send it to FDA and make an immediate release.

What info did the IDMC give you after each review that kept the study going? Continuing or ending the study is ultimately up to the sponsor correct?

The IDMC gives recommendations. They can recommend to continue, to continue but enroll more patients or to end the study for futility. The last recommendation was in April 2020 and they said to continue.

My dad was recently diagnosed with Grade 4 Glioblastoma brain cancer. Have you done any research or made any headway on treatments for this? There seems to be very little out there to help with it beyond the standard radiation therapy and chemo which is a bit disheartening.

I am sorry to hear that. We are not involved in this at all.

I know we're all in the dark on data, but did CEL-SCI have an internal estimate of when data would be released after 298 that you would be willing to share?

We extended the CRO contracts 3 times for one year. That tells you that the CROs and CEL-SCI expected to have reached the end of the study, 298 deaths, about 2.5- 3 years ago.

Does Multikine have a competitive advantage versus other cancer drugs that may also come to the market soon? If so, could you explain?

Yes. We are the only one going for a therapy to be given to head and neck cancer patients after diagnosis, before the surgery. There is no competitive drug.

Mr. Kersten, what are the company’s plans for moving forward if the results of the Multikine trial don’t meet expectations? Would it involve a greater and more robust effort in developing LEAPS?

Our manufacturing facility could be used for COVID vaccines work. Plus LEAPS.

Who can bench press more you or Eyal?

I think that I can, but Eyal may disagree.

Hey Geert, this is a two part question...

Where do you buy your snappy suits?....and what's going on with LEAP in terms of being used as a possible supplemental treatment in the fight against COVID? Is Cel-Sci going to get some of that COVID money?

Hong Kong. But who wears suits these days?

We are working with the Univ. of Georgia to repeat the animal protection data against COVID.

Hi Geert Has the Idmc performed a futility analysis in the last feb meeting they had ?

They do not tell us what analyses they perform. They only tell us the recommendation. But each meeting costs us about $300-400,000. I assume that represents a lot of data and analyses.

[removed]

From the most recent release:

Now that the long Phase 3 study is finished, the organizations who run the study are responsible for cleaning up/collecting all final data and analyzing it. This is a very big job since the study ran for 9.5 years in 100 hospitals in 24 countries. Once we know the final study results, we will share them with our shareholders.

Which will take longer, data lock or analysis?

Data lock first, then analysis

Hi Geert, thanks for the opportunity to ask questions!

What led you down this path and motivates your commitment to CelSci, the prospect of leading a successful business and the wealth and cache that goes along with that, or the potential to develop a treatment that will help thousands (or millions) of ill people?

Thanks!

When we started with the idea of immunotherapy, and even when we started the Phase 3 trial, the so called experts said that the immune system cannot be used to fight cancer. I wanted to make a big difference and prove people wrong.

There’s no motivation better than proving the nay-sayers wrong!

Absolutely!!!

Hi Geert, thanks for taking the time to do this. We've seen CROs administering other multi-thousand-patient, multi-year Phase 3 cancer trials take 8 or perhaps 10 weeks for the data scrubbing process. Given the scope of IT-MATTERS is certainly larger than most, do your conversations with the CRO indicate a delay of further weeks, or could it be months? Could we not have a topline release til 2021?

Apologies for the similar question to others, but after this many years of wait, it's important to know.

I do not know where you come up with this information. But, nevertheless, remember that this is a super long study, much longer than a normal study. In 24 countries and 100 clinical centers. We have to make sure no mistakes are made. NO SHORTCUTS!!!!!!! In the times of COVID. All that I care about is good data arrived at "by the book". Those are the instructions given to the CROs. Anyone who wants this drug to succeed will understand that.

I already responded to this. Let me point out again that your 8-10 weeks may be based on either erroneous information or really small studies.

Was there a risk or concern of accidentally triggering a cascade of undesirable immune system responses? Like a cytokine storm?

We have not seen any such things.

Hi Geert, big fan.

Can you please explain why you have refrained from exercising your warrants that are in the money?

Hoping the Multikine and Covid trials are successes!

Because I would rather exercise them at $100.

Sorry, but we are already working with someone. All the best.

Are there any updates on the use of LEAPS for COVID-19?

How soon after you receive the P3 results from ICON do you plan on sharing it publicly?

Keep up the great work!!!

I believe that I covered this already.

Thank you.

What exactly have you been lobbying the FDA for?

We have not been lobbying. We just want to make sure that politicians in DC know that we exist and what great benefits our Multikine would bring to cancer patients upon success.

Are you looking for a buy-out post data so that larger pharma can take the reigns and distribute multikine much faster to the patients or would the success of a positive phase 3 trial motivate cel-sci to continue alone in the production/propagation of multikine and leaps?

Let us just focus on getting the final results done by the book. Following our success we will have a lot of new friends.

After watching this stock and the results of PHASE II,,, the pictures that were on line that had to be taken down is what sold me on Multikine. Your stating that you believe it will be successful, is only an opinion, but your opinion will be regarded over everyone else's. Four Months approximately have gone by since the final event,, is there an estimate as to how long it will take to provide the results to the FDA ?

We have already answered this question.

A lot of us have seen the new job positions Cel-Sci has posted. Has Cel-Sci actually been actively reviewing candidates for these positions/hired anyone?

If so, seeing a short new employee update with a photo and their background/what they are now doing at CVM would be great!

Lovely idea, but no thanks. We will let our employees simply focus on their work.

Fair enough. No offense taken. But to be clear, your company has been hiring for the new positions posted?

Yes

Thank you for clearing that up for me.

One more quick question just more of a fun one. Some of my family members also have law degree backgrounds. From following you over the years they seem to respond to questions very similarly to you. In that they are clear, concise, and don't care to speculate on things too much :)

My question from that is this: In law school do you they teach all of you how to respond to questions? Is there a set of rules they give lawyers to ensure they don't step on their own feet?

Anyway, much respect. I am rooting for you and all of us. I hope all your hard work and patience pays off in the end for everyone in a positive way!

No. My toughest lessons come from my wife who was an AUSA and Justice department organized crime prosecutor.

Just wanted to say that my name is Geert, too. Do you ever get annoyed with people asking how to pronounce it?

No. I am used to the abuse. That is why my son is called Alex.

Geert, any concerns about big pharma or the FDA playing any games to prevent your product from getting to market? Is it possible it could be approved in a foreign country before the USA?

Data is king. Survival data in cancer is the best there is. We expect the US to be first.

Herr Kersten,

Can you provide any update on the expansion/operations of your cold-fill facility?

Mit freundlichen Grüßen,

Jager

The facility is currently being expanded.

Mr Kersten (big fan I am)...Knowing cancer trials have the Big 3 for approval ..1) being OS 2) PFS and 3) Quality of life.....knowing that the trial was designed under a strict format... Since the FDA now adays is a little more flexible since then...is Quality of life on the table for Multikine acceptance/approval ?

FDA being more flexible is always a good thing when you apply for marketing approval.

Geert, I know that you hold a patent for using Multikine in managing cholesterol. Has anything come of this effort? I don't think I've seen any mention in any articles/press releases on the use of Multikine in managing cholesterol.

No. We have been stressed paying for a $60 million trial. First A, then B.

Hello Geert, thanks you for your years of work and this AmA.

From your personal feeling would you even like to get bought out as a company? I think you and the other Board Members are seeing this company like their own child, which could be hard for you to leave for another company.

Dont get me wrong I dont want to know any financial ifs and would bes, just your personal opnion on *loosing* the company to another. As you said before CVM is family?

Shareholder here, and I wouldnt be unhappy about a nice BO, obviously.

Greetings from germany.

Thank you again, I hope you guys can change the world to a little better place :)

The decisions must all be driven by one thing only. How do you create the greatest benefit for the largest number of cancer patients. This will benefit the shareholders as well.

Was there ever any thought of dosing Multikine immediately AFTER surgery as well? Seems like a logical step?

No, because at that time your lymphatics are already destroyed from surgery and the tumor antigen for the specificity of the immune response is gone.

Is there anything that you learned from running the Multikine P3 study, and what you would do change if you could?

Yes!!!!! Not hire Inventiv.

Shareholder for 18 years! At this point, can Multikine be administered to any of the patients in the study who received placebo?

No placebo. They all get the standard of care. No crossover.

Hi Geert, hoping you see this. I am curious what applications your medication might have for lymphangioma patients? I have a young sister who is currently exploring new treatments for herself.

Sorry to hear. We have no information on this at all.

One of the most common (and ridiculous) short arguments is that the trial failed in 2016 and that CEL-SCI has been letting the trial run for the last 4 years anyway. Could you in a sentence or 2 skewer this theory?

FDA and the IDMC reviewed the study many times afterwards and obviously did not see that.

Is there anything you would change along the way to the phase 3 data release. Examples: where you built your facility/ would you have started with a different type of cancer; anything???

No. It was a long and hard road, but we believe that we will be successful.

Hi Geert - Given what is happening to Tesla's stock today on the news of a stock split, would you consider splitting your stock also? Love to see the shorts burn!!!

Also do you personally get the interest that the shorts pay or does it go to Cel-Sci directly?

I do not loan my shares out to the shorts because i believe that shorting a cancer company is simply immoral. Therefore neither the Company nor I get that money.

What would be the benefit of using your treatment rather than something like proton radiation therapy in conjunction with chemo? I have a family member who has Stage 4 Squamous Cell Carcinoma and has been recommended this treatment, but we are always looking for something better.

We have to follow the standard of care for a clinical trial. That requires surgery, radiation and maybe also chemo depending on the pathology results.

To add up to Geert's reply... Phase 2 showed that cancer disappeared completely in certain cases. If I remember correctly, there was no need for surgery and radiation/chemo

In theory one would think that tumor disappearance may result in skipping surgery. However, since surgery is a required standard of care treatment, for the purpose of the study surgery is still required.

Even though you are waiting for data/analysis from the CROs- do they keep you updated with what % they are completed with and if so- can you share how far along they are?

We cannot share that because that would tell you nothing. It is not a linear process.

Geert, as investors we appreciate all the publicity you have been pushing. fireside chat, PR's, but i would like to know what your motivation is for interactions such as these on reddit and twitter some have seen as re-assurances of positive data outlook while others see this as a negative light for cel-sci; are you just hoping to get the word out to investors or do the naysayers just fuel a fire such that you are driven to respond?

We believe that we can do better in the treatment of cancer. We want to show people that it is possible to have a non-toxic cancer drug and use their own immune systems to fight cancer. However, since things have taken so long, we are not well known. Good data will change that, but in the meantime we simply aim to spread our story.

What "new information" was presented to Cel-Sci that made you remove your request to the FDA to enroll additional patients?

In early 2016 the annual report to the regulators showed the overall death rate in the study was lower than expected. That is why we felt we needed to add more patients. The request for more patients was withdrawn in early 2017 because the 2017 annual report filed early in the year showed that the overall death rate had caught up to the expected death rate. Therefore the increase in patients was no longer needed.

Hi Geert , what causes head and neck cancers ? (I have a pre cancerous lesion on my neck that’s currently being treated)

Smoking, drinking, HPV

I am a thyroid cancer patient and the treatment is scary. It seems that your approach to treating cancer is by boosting over killing cells. How will big Pharma respond to that?

They will want to buy us upon success.

Are you aware of stock messaging boards such as Stocktwits? And if so, do you regularly check them for laughs?

Hardly ever

Just curious with such a large worldwide trial...what country has the most patients in the trial?

We are blinded to these details

Was the FDA aware of the former CRO debacle prior to them initiating their clinical hold?

Did your face to face with the FDA years ago directly affect their decision to lift the hold?

FDA is fully aware of all that happened and reviewed everything.

Will you ever provide deep details to shareholders on the lawsuit against the former CRO? And the details about the IDMC recommendation to stop the study with the following study lock by FDA? We know the high-level picture, but not the details and the full story.

We would love to, but are prohibited to do so since it was private arbitration. If we could, you would understand a lot.

Have you been approached lately with a deal from the shorts?

There will always be someone who stands on the opposite side of the street. For the privilege of being short about 10 m shares, many of which they shorted between $3 and $10, they get to pay 73% interest. Let them continue to pay that much money. They will provide rocket fuel to our stock when we have proven Multikine to work.

1 - What is the driving factor behind your decades chasing this alternative approach to treating cancer?

2- When did you last buy or sell CVM stock?

3- Why did it take this long for such an important study to be complete? The current climate at the FDA seems much faster.

4- What do you expect to be the biggest challenge in bringing Multikine to the market if it is approved?

My wife and her family have had lots of Head and Neck cancer issues so thank you!

1) we want to make a difference and take care of our families in the process of doing so.

2) I sold in 2000, 20 years ago, just a small amount. I last bought earlier this year.

3) The patients are not dying cancer patients. About half of them are expected to be alive in 3 years. That makes for a larger study and a longer follow-up. And then patients have not been dying as fast as we had expected. That alone added 3 years.

4) New things always are harder to achieve. But with good survival data problems melt away.

Geert, You had said data very soon months ago. How would you describe that now?

We cannot predict since we are not doing the work. And I am not going to give pure guesses.

Can you possibly tell who is doing the work?

Ergomed and ICON

Bent u Nederlander/Vlaming? Zo ja, waar hebt u dit onderzoek gedaan? Nederland, ergens anders in Europa of de Verenigde Staten?

Sorry, but I do not speak utch.

Hi Geert,

My name is Adam. As we all know the trial failed years ago and was recommended to be shut down multiple times.

We are wondering when the failure is finally made public and shareholders are left holding a bag of nickles and pennies. What will be your next steps? Will it be to convert into a covid company? Or will you start selling your facilities?

AF

Adam: I am glad that you know so much more than does the FDA, and 23 other regulators, as well as the IDMC, all of whom have seen the Phase 3 data and somehow have reached opposite conclusion to your statement. At least I put my money where my belief is.
Go play with your doggie.