I am Geert Kersten, the CEO of CEL-SCI Corporation. I'm here to talk about our recent presentation at ASCO 2022 regarding our investigational immunotherapy Multikine and the results from the largest ever head and neck cancer Phase 3 clinical trial...

When will the BLA be filed? I follow quite a few small bio-tech and most file the BLA within 6 months of completing clinical trials....

Thank you for your question. Since we must respect the regulators, we cannot provide a timeline at this time for a BLA. We can say that we are working on it. In terms of "most" small bio-tech companies, I think you will be hard pressed to find one that conducted a 10-year trial on almost 1000 people with overall survival as their endpoint (versus simply a response trial). Further, we also do not believe there are other studies out there where the investigational therapy was given before the standard of care, like ours. When you give a drug after the standard of care, it is far easier to test. Our study had to be carefully designed to account for the administration of standard of care after the drug treatment. This takes time to process, as it is unique and, as far as we know, unprecedented.

I want to thank all of you for participating. My team and i have worked on this cancer drug for 30 years. We have given it our all and we still do so today. We believe that we have great data that could help a large number of patients, with no toxicity added. We are trying to dot every I and cross every T to bring this drug to market. We believe that the only thing that will matter to patients and their families and also to our shareholders in the end is that we were successful. We thank you for your support. I really does take a village.

I will sign off now. I wish you a wonderful summer.

Sincerely,

Geert Kersten

As someone that has seen the raw data and had it explained to you, are you all but certain you have what you thought you had? A standard of care for head and neck cancer?

Personally, yes I do. And this is seen in the ASCO poster. Survival is the gold standard for cancer drug approvals.

Dear Mr. Kersten, Thank you for hosting this Q&A. Can you comment on the company's go-forward plan, and the most recent QC re-submission at ClinicalTrials; had those deficiencies been syntactical in nature?

Thank you for your question. As for clinicaltrials.gov, their QC is purely format driven and not a review of the substance of the data. We have been told that formatting criteria can depend on each reviewer at the website, and so it is common to have several rounds of revisions.

As for the go-forward plan, there are two main aspects. The first is the regulatory clinical pathway, which is in process. We must respect the regulators and as such we cannot share any timelines. Second, we are also working on the factory validation and getting drug manufacture back online after the expansion of the manufacturing facility.

Other companies share timelines, what makes cel sci so different

Thank you for your question. Other companies may give timelines when they are in the formal submission pipeline and have definite dates provided by the FDA regulations. We have not yet submitted our BLA, and thus there are no formal timelines in place. We can say that we are working on the BLA process.

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In terms of what makes us different from other small bio-tech companies, I will cut and paste what I wrote to a similar question: I think you will be hard pressed to find one that conducted a 10-year trial on almost 1000 people with overall survival as their endpoint (versus simply a response trial). Further, we also do not believe there are other studies out there where the investigational therapy was given before the standard of care, like ours. When you give a drug after the standard of care, it is far easier to test. Our study had to be carefully designed to account for the administration of standard of care after the drug treatment. This takes time to process, as it is unique and, as far as we know, unprecedented.

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Our peer-review publications started with two abstracts and a poster with ASCO. You will see additional peer-reviewed publications shortly. I have to admit that if we were a large company, things would probably go faster. Even though we have added to the team, we are still a small company with the largest and longest head and neck cancer study of all time. We are being diligent to make sure that everything gets done correctly. We work seven days a week.

Hi, Curious what is the status of current communication with the FDA and any scheduled communication?

We will make a public announcement when we have something definite to announce. No one has a greater interest in driving this forward to sucess than we do--except cancer patients!

Are we missing additional data about Multikine, and if so, when will we see it?

Clinicaltrials.gov will publish the results shortly. There will be additional details in scientific presentations and publications to come. We have succeeded where others have not succeeded in decades. As shown in our ASCO poster, a large portion of patients had early objective tumor responses in just a few weeks before surgery. As far as we are aware, and we have looked, there has not been a single spontaneous regression of this disease in the literature. Thus, our early responses prove that Multikine works (p<0.0000001). The data also showed that patient with an early response had their death rate cut by more than 60% (p<0.0001). It is obviously critical that patients gain access to these benefits as soon as possible.

Mr Kersten, You estimated having enough money through the end of 2023, does that assumption include the burn rate of the outside consultants that were engaged to take us through the BLA?

Do you anticipate needing more outside help?

Also, we were aware of a lobbyist being paid by CVM. Is there still an active contract?

We do not have a lobbyist on contract. Yes, the projections included our spend on outside consultants.

Hi Geert, can you help us understand why CVM has yet to be accepted by the non-retail investment community?

We had over 40% institutional holdings. Then biotech was destroyed in the stock market.

The more we publish data, the more credible we will become. There is a lot of work going on behind the scenes.

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Yes.

Thanks Geert. Confused by the negativity around CVM...seems like an amazing breakthrough in cancer treatment.

Could you discuss your patent position? How much life is there to the key patents on your cancer treatment? Are there additional patents applications in the works to protect CVM assets?

Thank you for your question. Patent protection is not critical to protecting our product. We have orphan drug designation which would provide seven years of exclusivity. In addition, our product is not readily copied, because it is a complex biologic. Even if someone could copy it, they would somehow need to prove equivalence, which would require a significant Phase 3 study that would take many years to complete.

Has your family sold any stock?

No.

What was the purpose of the recent S-3 allowing further shares to be sold?

It allows us to sell shares under the best circumstances during the next 3 years.

Thanks, Geert, for the session.

My question: is the manufacturing facility approved by FDA? Or in process of being approved by FDA? Once approved, how much MK can it produce in a year?

Thanks.

A facility approval does not come until the end of the full approval process. We are still validating it.

Hi Geert,

Really appreciate that you've spent so much time with us today.

Regarding suppressed share price: does the company have a plan to buy back some shares?

1. To promote itself
2. To make some profit down the road

Or this is no such need at all?

Thanks.

The whole biotech sector is flattened. Data is key for us to make a come-back. To be believed DATA must be peer reviewed. That is what we are working on. Noone has a greater interest in our success than we do.

Mr Kersten, Thank you for the QA.

Its been one year since the top line data. When will we see the complete data set?

Complete data will come out with clinicaltrials.gov and subsequent peer reviewed publications and presentations.

Is the company still for sale at a reasonable price?

I have bought so many shares over the years and I have not sold any shares in the last 20 plus years.

Can you share any more insight or perspective on how the data was received at ASCO by physicians?

Yes! We had about 100 physicians visit our booth while I was there (which was only three hours!) and all of them expressed support and interest in using Multikine with their patients.

MacroGenics recently acknowledged the deaths of seven patients in their Phase II trial assessing combinations of enoblituzumab with either retifanlimab or tebotelimab as first-line treatments of patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN).
Given the positive safety and efficacy of Multikine during P3, does this further establish CEL-SCI as the only true player in SCCHN?

The literature describes head and neck cancer as one of the most difficult to treat and there is a clear unmet medical need to improve outcomes for these patients. We are aware of at least six clinical trials for SCCHN that failed in the last few years, most by major pharmaceutical companies. The majors are trying, but failing at this. Our data shows that objective responders live a lot longer with no toxicity added to the treatment. This is unprecedented and we believe that patients should get access to this drug as soon as possible.

Geert. Thanks for your time.

Regarding future peer-reviewed publications and presentations: what kind of magazine (like NEJM) and conferences can we expect?

Admire your and your team's work.

Thanks.

I leave that up to our team.

What type of partnership would you entertain and what would that investment look like?

Anything that helps us get Multikine to patients while at the same time giving the due reward to our shareholders.

Do you still expect significant updates before the end of the year?

Yes

Why do you think there is such skepticism and limited acceptance from the investment community?

The downside is that we are doing something completely new and different and that is always more difficult. On the other hand, that is also the upside. You create something that has unique benefits and you have no competition.

Is there anything questionable or detrimental in the data that retail shareholders may not understand?

Look at the ASCO poster on the first page of our website. If you are treated with surgery plus radiation, you have excellent benefit. If chemo is added, you do not.

What are your favorite and least favorite aspects of running a publicly traded company?

The least favorite is easy. In June 2021 we raised about $36 m. I received threats to my family and my life for doing something that turned out to have been very much the right thing.

My most favorite is when I see that we can give our patients an almost 4-year additional life expectancy. That is why we are working so hard on getting this drug approved.

Have you reported those threats to the authorities? That's pretty serious stuff there.

I told my 105 pound German Shepherd.

Thanks for the reply! Love ya Geerty! I know you have to make hard decisions, but I think at the end you'll look back with very few regrets, knowing that you always did what you thought was right (even if it was hard). Cel-Sci was my first financial investment ever. It's been a rough ride, but you still have my confidence! Even if we lose it all, at least we tried!

So far we have been beating the odds.

Many investors confuse the share price with the actual work at the company. They seem to be related, logically, but a lot of of the time they are not related. Right now we have a lot of dislocations in the world. At CEL-SCI just put our nose to the grindstone and focus on the few things we can actually control.

Is the silence of Cel-Sci that investors hate a simple result of the fact that you all don't care... meaning you're busy getting the actual work done, have the money to outlast the negativity and short-sellers, and will just let results speak for themselves?

Or do you have internal policy, peer-review process, or regulatory obstacles to sharing more info with investors?

Or is it that, after like 10 years trying to get through the p3 process, you simply don't have any investor relations personnel left? ;)

Like we have said before, we are working on getting this drug approved. We cannot give you step by step updates. We have dedicated over 30 years and many millions of $ to the development of Multikine and we must do it right. That will be the only thing by which we will be judged at the end.

Can you comment on the comment that STATnews made after ASCO regarding the graph and that it showed Multikine patients dying faster? It seems he doesn't know what he's looking at but being that he has such a following it creates doubts. Please clarify. Thank you

I can say that further data will be published on clinicaltrials.gov and in subsequent peer reviewed publications and presentations.

The recent reveal from Phase 2 GSK was that 6 months of their immunotherapy resulted in full remission on ALL patients. Aren’t we at at least half remission for our group or tumor reversal? Why don’t you market that we’d have 100% too if we didn’t have the 3 week treatment limit? How do you get around the fact that you still have a blockbuster but your trial with Chemo reduced its potency?

That study was for colon cancer and involved a six-month treatment. Head and neck cancer is quite different and we are not allowed to treat for more than three weeks before surgery.

Mr. Kersten,

If all the CVM team members have been dedicating their time and efforts, and that if you feel where CVM should be in its processes , what do share holders have to look forward to before yearend and moving forward to '23?

Our goal is to get the drug approved. That will help both cancer patients and shareholders.

Hi Gerrt,do you think that new blood at the top of cvm is necessary to move forward in getting this drug to market?

No. In fact, one the reasons why we are not as fast as a big company is that our work is so specialized and has such a long history that we are dependent on a very small number of people with deep institutional knowledge about the drug and its trials. But, we have also expanded to team to include "new blood" along with my old blood and that of my longtime colleagues.

What are the comparisons in extension of life results for Keytruda and Multikine in their respective Phase III trials?

Several big differences. First, Keytruda is given to recurrent or non-resectable tumors. Multkine is given to newly-diagnosed tumors that are resectable. So, very different there.

Keytruda received accelerated approval based only on objective response rate of about 16%. It tried to show overall survival benefit but failed in the KEYNOTE-40 trial.

Multikine has an objective response rate that is similar (16% in the lower-risk group and 8.5% in the ITT), but Multikine is better in that it showed clearly that these objective responses lead to improved survival. The ASCO poster shows the reduction in death rate of more than 60% from 54% down to 22%. Keytruda hasn't shown anything as good as that in head and neck cancer.

Finally, Keytruda's duration of response was a few months, which is not a survival benefit.
Multikine showed a nearly four-year life extension in the proposed indication population.

Thank you very much for this detailed response, Mr. Kersten! You are a true cancer immunotherapy pioneer pushing ahead in a field so many others have doubted for far too long.

Do you believe the FDA will take the differences you cited into consideration when they look at potential approval for Multikine?

I know that I am not an expert in this field. My strength is in putting together great teams and raising the needed funds for them to do their work. I have done that. My team believes that we will be successful and I do not believe that we would have made this far through so many difficulties if we were not meant to be successful.

Working against cancer is an amazing commitment. As a CEO, do you earn 300x the pay of your lowest level employees?

Not even close and on many occasions during the development of our drug I took $0 salary. On top of that I have invested more money into the company than I have received in salary in many years. And I have not sold stock.

What’s the agreement w peer review? Do they have no limits on producing the dang thing or what? It makes no sense that they get to take a year to finish a review. Is it endless or is there a deadline of any kind?

You will see more soon. I too am surprised how long everything takes, but in the end there is only one thing that counts. SUCCESS!

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Head and neck cancer is not brain cancer.

What was the feedback from KOLs like last year? Are they still involved in any processes at the moment?

We convened 2 KOL meetings and we met with doctors at ASCO. They have all confirmed that a new medicine is desperately needed for these cancer patients and that they would like to use it in their patients.

Will you be requesting a pre-BLA meeting with the FDA this year or next?

Our goal is this year.

Did you create the S3 for producing a redo trial or a trial having to verify the algorithm???

Joe_CVM answered correctly.

Is there a biomarker that suggests what patients will respond to the drug and what patients will not, e g hla-2?

The histopathology data will soon be presented in a very credible forum.

What other cancers have you identified as potential future candidates for Multikine? and do you expect to initiate studies in them at some point in the future?

Or will you get Multikine in the hands of physicians first and let them start inevitably prescribing off-label and look at results that way for future targets?

The goal is to get Multikine into the hands of physicians for head and neck cancer as soon as possible.

Do you see the company being bought out or are you planning on running the company?

The future of Multikine (if approved) should be determined by how it can be brought to the greatest number of patients in the shortest amount of time. Whether that's through a buyout or partnership or some other arrangement remains to be seen.

Is it taking longer to recruit staff than initially expected?

Everything is more difficult and taking longer these days.

Mr. Kersten,

What, in your opinion, is the worst-case scenario regarding Multikine approval, and what contingencies have you planned should the worst transpire?

For example, if another trial is required or requested, how would CEL-SCI move forward with timing and funding?

It’s good to stay optimistic and prepare for ideal outcomes; however, I’d like to know that the company is planning for less-than-rosy results.

Over the 30 years we have been told more times than I can count that we are on the wrong track, that we will never succeed etc, yet somehow we have completed the largest ever head and neck cancer study with great benefit for patients who receive radiation after their surgery. That is well over 200,000 patients per year. Since this is an unmet medical need, I simply cannot imagine that we will not get to market.

Are there any plans on near-term (1 year or so) dilution?

No.

Thanks for your response and doing this today. Good luck on this last stretch!

Thank you!

Who determines what's included in SOC?

Physicians

Will you have to sell the benefits of MK to the FDA, or will it be obvious?

The job of FDA is to challenge everything a company tells them. That is why things take so much longer than one would expect.

Geert, what do you personally feel is the most important result from the trial?

The statistician told me that no matter how he looks at the data from the patients who get only radiotherapy after surgery, there is a benefit to the patient in every place. That is the key along with the lack of toxicity and the unmet medical need.

Mr. Kirsten: Why is there still such skepticism and limited acceptance from the investment community? You've published solid data, but still no significant investments and volume is almost nil.

It is ugly out there in the stock market. We even got kicked out of the Russell 3000 index. Yet none of those actions have anything to do with our data.

Geert, You said multiple times, "the offers come in when the data is published". Any comment?

That is how it usually works. It is true for CEL-SCI as it is for any other company. Data rules.

Have you been in touch with the doctors responsible for the NCCN guidelines? What are their thoughts if so, and when would they integrate this in their guidelines for scchn ?

Not yet. We simply do not have the time.

Given that p1 and p2 data sets are so old, would there be any concern of quality/ specification from the FDA?

No. The key is that our Phase 3 results repeat what we saw in the Phase 1 and 2 studies

Hi again,

Did i miss any results on TILs in the resected tumours ?

None of that data has been made public yet

If you had more resources, would you be able to deliver this to patients faster? E.g you are looking at FDA now but wouldn't big pharma be able to accelerate this to get it internationally at a faster time frame?

Maybe, but also maybe not. Our study and development is unique. That means that adding bodies does not help.

Could you please describe, in laymen’s terms, the balance of the process from where the company and drug status is now to market?

We have completed Phase 1, 2 and a 10-year Phase 3 approval studies for a major cancer, head and neck cancer. We are now working on approval of the drug. The idea is unique. We believe that immunotherapy should be given before surgery, radiation etc have weakened the immune system. Noone has ever done that. We are proving this idea on the basis of head and neck cancer because the last FDA approval in advancer (stages 3 and 4) primary (not yet treated) head and neck cancer was about 60 years ago. Our data was recently presented at ASCO, the premier US cancer conference and more data will be presented in the future. Our single-minded goal is to get the drug to patients.

Do the peer review companies require .gov or their schedules to determine publishing date? Are they saying it’s ready to go?

These two are completely unrelated.

Geert, not sure if this was asked yet, but are the phama giants still impeding your efforts, or are we beyond that?

If a lot of money is involved, how do most people act?

At what point do you start other Multikine trials and is there any benefit for surgeons from the use of Multikine?

Right now all of our focus is drug approval.

Who do you want to merge with or have buy the co.? Do you think they'll buy for a $200-$400 pps?

Our goal is to bring Multikine to cancer patients. We know that this achievement will result in the gains our shareholders are hoping for.

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Yes. The data is really good.

Is it just eyal that works on the peer review papers or has the full dataset been shared with other scientists/oncologists so that they can also study the dataset and put forward their conclusions?

We have a small core team who works on the scientific papers. They are the same people doing everything else too. That is slowing us down. Once the core of a paper has been written, it goes out to many experts for input and correction/suggestions.

What are your thoughts on the commericialisation and sales steps for Multikine on approval? Have you started to plan for this or is this where you see a partner/acquisition being able to fufill the remaining pieces to getting this to doctors/pharmacies etc. ?

We have, but the priorities are currently on FDA approval and manufacturing validation. It is quite possible that Multikine will be partnered in some way.

How many patients can you deliver this to once the expansion has been completed? and do you charge for course per treatment or per dose?

There are about 210,000 patients worldwide annually who meet this description. Initially we can treat about 15- 20,000.

FDA would sometimes give priority review/accelerated review designation etc. on top of drugs that are on an orphan drug designation status, do you think the multikine fits into these accelerated forms of application?

Yes, we do.

2 recent LIES I've heard about CVM : 1.) No buyout before approval 2.) No approval before 2024

What do you think?

Opinions are like t-shirts; everyone's got one.