In August of 2020 I joined Reddit to discuss cancer immunotherapy and the details of our head and neck cancer clinical trial for Multikine. Our mission at CEL-SCI is to improve the treatment of cancer and other diseases by utilizing the immune system; the body’s natural defense system.

In the time since my last AMA, research in cancer immunotherapy has continued to make great strides and so has CEL-SCI. Our team has recently returned from ASCO 2022 where over 40,000 oncology professionals from around the world attended the largest annual conference focused on global cancer care.

2,500 abstract presentations of cutting-edge research were presented with one of those being from our Chief Scientific Officer, Eyal Talor, Ph.D.

Today I am here to answer questions regarding our abstracts published at ASCO, the evolution of cancer immunotherapy and the ever-changing landscape of cancer treatment.

You can learn more about CEL-SCI on our website: CEL-SCI.com

Proof: Here's my proof!

EDIT: It is now 4:00 PM ET. 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.

Please do continue to ask questions as I plan to visit this thread in the coming days and weeks ahead.

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

Sincerely,

Geert Kersten

Comments: 238 • Responses: 68  • Date: 

anewbie314 karma

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....

CelSci20 karma

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.

CelSci10 karma

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

CandidateIll5989 karma

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?

CelSci13 karma

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

JagerGraf7 karma

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?

CelSci7 karma

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.

KillTheShorts2 karma

Other companies share timelines, what makes cel sci so different

CelSci5 karma

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.

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.

StatisticianUnited907 karma

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

CelSci9 karma

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!

cvmsuperlong27 karma

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CelSci15 karma

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.

Ok-Inspector87376 karma

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

CelSci14 karma

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.

Joe_CVM6 karma

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?

CelSci5 karma

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

Hunters_Iphone5 karma

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

CelSci7 karma

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.

mcintoda3 karma

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

CelSci6 karma

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

redditwho9993 karma

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.

CelSci2 karma

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

Top-Avocado-69913 karma

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?

CelSci9 karma

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.

RicRod10003 karma

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CelSci2 karma

Yes.

Love-Will-Privail3 karma

Has your family sold any stock?

CelSci5 karma

No.

Strong_Recording32102 karma

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?

CelSci8 karma

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.

redditwho9992 karma

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.

CelSci2 karma

I leave that up to our team.

Joe_CVM2 karma

Mr Kersten, Thank you for the QA.

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

CelSci6 karma

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

Strong_Recording32102 karma

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

CelSci5 karma

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

Strong_Recording32102 karma

Is the company still for sale at a reasonable price?

CelSci6 karma

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

Ok-Technician-94812 karma

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

CelSci5 karma

Yes

redditwho9992 karma

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.

CelSci3 karma

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.

Strong_Recording32102 karma

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

CelSci5 karma

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.

dxrules441 karma

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 ?

CelSci3 karma

Not yet. We simply do not have the time.

dxrules441 karma

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

CelSci3 karma

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

RealisticAd68991 karma

Hi again,

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

CelSci4 karma

None of that data has been made public yet

dxrules441 karma

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?

CelSci3 karma

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

Strong_Recording32101 karma

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

CelSci2 karma

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.

Consistent_Rip_41551 karma

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

CelSci3 karma

These two are completely unrelated.

Adam_F_Fishman1 karma

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

CelSci5 karma

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

Strong_Recording32101 karma

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

CelSci4 karma

Right now all of our focus is drug approval.

Strong_Recording32101 karma

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

CelSci3 karma

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.

Strong_Recording32101 karma

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

CelSci4 karma

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.

calfral1 karma

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

CelSci5 karma

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.

Consistent_Rip_41551 karma

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?

CelSci3 karma

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!

Faisalowningyou1 karma

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CelSci3 karma

Head and neck cancer is not brain cancer.

dxrules441 karma

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?

CelSci3 karma

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.

dxrules441 karma

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. ?

CelSci3 karma

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.

dxrules441 karma

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?

CelSci2 karma

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

dxrules441 karma

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?

CelSci2 karma

Yes, we do.

dxrules441 karma

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

CelSci4 karma

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.

Consistent_Rip_41551 karma

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

CelSci2 karma

Joe_CVM answered correctly.

dxrules441 karma

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

CelSci7 karma

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

Top-Avocado-69911 karma

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?

CelSci5 karma

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

VforVirtus1 karma

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

CelSci7 karma

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.

Joe_CVM4 karma

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

CelSci7 karma

I told my 105 pound German Shepherd.

VforVirtus1 karma

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!

CelSci5 karma

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.

Top-Avocado-69911 karma

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? ;)

CelSci6 karma

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.

Joe_CVM1 karma

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

CelSci5 karma

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

Consistent_Rip_41551 karma

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?

CelSci4 karma

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.

Monhaxanh1 karma

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?

CelSci3 karma

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

Successful-Archer-461 karma

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

CelSci3 karma

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.

Strong_Recording32101 karma

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

CelSci8 karma

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.

Strong_Recording32102 karma

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?

CelSci5 karma

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.

yocuzzivinny1 karma

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

CelSci7 karma

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

heiblum13 karma

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CelSci5 karma

Yes. The data is really good.

FrugalNorwegian1 karma

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

CelSci5 karma

Our goal is this year.

AlarmingDrop20551 karma

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

CelSci7 karma

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.

dxrules441 karma

Is it taking longer to recruit staff than initially expected?

CelSci3 karma

Everything is more difficult and taking longer these days.

SubvocalizeThis1 karma

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.

CelSci5 karma

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.

HaulingLumber1 karma

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

CelSci4 karma

No.

HaulingLumber5 karma

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

CelSci5 karma

Thank you!

Annette_Baez1 karma

Who determines what's included in SOC?

CelSci3 karma

Physicians

Bidensmelledme1 karma

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

CelSci4 karma

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

Strong_Recording32101 karma

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

CelSci7 karma

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.

Annette_Baez1 karma

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.

CelSci3 karma

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.

Annette_Baez1 karma

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

CelSci6 karma

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

Consistent_Rip_41550 karma

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

What do you think?

CelSci6 karma

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