Cel Sci Corporation New (CVM) News

Change in management - New Chairman - Guy with experience in raising money.
https://feeds.issuerdirect.com/news-release.html?newsid=5946140769547282

July 8, 2024 9:15 AM
CEL-SCI Appoints Robert Watson as Chairperson of the Board
CEL-SCI Corporation (NYSE American: CVM) today announced that Robert (“Bob”) Watson, who has served as a Director of the Company since 2017, has been appointed Chairperson of the Board.

Bob is an accomplished business leader who began his career as an investment banker. With over four decades of experience across various healthcare markets, Bob brings extensive expertise in capital formation strategies and partnerships to drive an efficient capital structure. During his career as CEO or President of private and publicly traded companies in the healthcare sector, Bob negotiated over a half dozen exits and more than $750 million in capital transactions including IPOs, secondary offerings, and debt instruments.

“I have greatly appreciated Bob’s guidance as a Director of CEL-SCI. His recent retirement from an active CEO role created the bandwidth for him to assume additional responsibilities as our Chairperson. The team and I are excited to have Bob involved at this level where his capital markets expertise will be highly valuable,” stated CEL-SCI CEO Geert Kersten.

Based on robust efficacy and safety data in over 750 patients for its immunotherapy drug, Multikine, CEL-SCI received the U.S. Food and Drug Administration’s go-ahead to conduct a confirmatory Registration Study for the treatment of newly diagnosed advanced primary head and neck cancer. Multikine, a true first-line cancer therapy, significantly extended life in its target patient population demonstrating a 73% survival rate with Multikine vs. only 45% without at 5 years after treatment. The small, focused, confirmatory Registration Study will enroll only 212 patients with a high unmet need for an estimated 100,000 patients annually.

Bob Watson commented, “Having been on the path with CEL-SCI toward FDA approval of Multikine, it is my honor to be able to stand side by side with the management team as we complete the final leg of this amazing journey to bring a pre-surgical immunotherapy to patients with head and neck cancer. As stated previously, we are very confident that the Registration Study will confirm the excellent safety and efficacy results demonstrated in prior studies.”

About CEL-SCI Corporation

CEL-SCI believes that boosting a patient’s immune system while it is still intact should provide the greatest possible impact on survival. Multikine is designed to help the immune system "target" the tumor at a time when the immune system is still relatively intact and thereby thought to be better able to mount an attack on the tumor.

Multikine (Leukocyte Interleukin, Injection), a true first-line cancer therapy, has been dosed in over 750 patients and received Orphan Drug designation from the FDA for neoadjuvant therapy in patients with squamous cell carcinoma (cancer) of the head and neck. Multikine significantly extended life in its target patient population demonstrating a 73% survival rate with Multikine vs. only 45% without at 5 years after treatment. Based on this very strong data, the FDA agreed to CEL-SCI’s target patient selection criteria and gave the go-ahead to conduct a small, focused, confirmatory Registration Study which will enroll 212 patients. CEL-SCI will enroll newly diagnosed advanced primary head and neck cancer patients with no lymph node involvement (determined via PET scan) and with low PD-L1 tumor expression (determined via biopsy), representing over 100,000 patients annually.

The Company has operations in Vienna, Virginia, and near/in Baltimore, Maryland.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. When used in this press release, the words "intends," "believes," "anticipated," "plans" and "expects," and similar expressions, are intended to identify forward-looking statements. Such statements are subject to risks and uncertainties that could cause actual results to differ materially from those projected. Factors that could cause or contribute to such differences include an inability to duplicate the clinical results demonstrated in clinical studies, timely development of any potential products that can be shown to be safe and effective, receiving necessary regulatory approvals, difficulties in manufacturing any of the Company's potential products, inability to raise the necessary capital and the risk factors set forth from time to time in CEL-SCI's filings with the Securities and Exchange Commission, including but not limited to its report on Form 10-K for the year ended September 30, 2023. The Company undertakes no obligation to publicly release the result of any revision to these forward-looking statements which may be made to reflect the events or circumstances after the date hereof or to reflect the occurrence of unanticipated events.

* Multikine (Leukocyte Interleukin, Injection) is the trademark that CEL-SCI has registered for this investigational therapy. This proprietary name is subject to FDA review in connection with the Company's future anticipated regulatory submission for approval. Multikine has not been licensed or approved for sale, barter or exchange by the FDA or any other regulatory agency. Similarly, its safety or efficacy has not been established for any use.

View source version on businesswire.com: https://www.businesswire.com/news/home/20240708501317/en/

Gavin de Windt
CEL-SCI Corporation
(703) 506-9460

Friday's daily short sale volume was 55.72% (as reported by FINRA) but despite all the heavy manipulations by the shorts, the PPS went up 10.00%. The short borrow fee went up to 85.44% and the short shares availability came down from more than a million shares to only 2000 shares that are currently available! With all the expected news coming in from EMA, MHRA, Health Canada and FDA, it should just be a matter of time until Multikine will be approved and the heavy manipulation by the shorts will come to an end. To keep the PPS low, the shorts have increased their position to currently 8.04 million shorted shares (short float of 15.33%) - up almost 1 million shares since last month. I am so happy for all the cancer patients who will hopefully soon be able to profit from Multikine! GLTAL!! Tick tock, tick tock...

I suspect that enrollment will indeed take about that 'year' - unless some big pharma with deep pockets signs on an starts opening some doors for them and shaking the 'money tree' to grease the skids. That could speed things up by at least a couple of months.
A year would be blazing fast. This indication is about 1/3 the size of the previous trial, so enrollment will be slower. That trial maxed out at about 25/month. I would think 10-15 a month would be reasonable once they get the same number of sites up. But it takes a long time to bring sites up, does not happen in a few months.

I do think that a conditional approval for Multikine, based on beneficial tumor regression data, is possible by sometime in 2026 as well.
That is probably the million dollar question. I would want to see the actual trial design before having a firm opinion, but there are issues here. To my knowledge the only surrogate the FDA has accepted in this area is pCR (pathological complete response, no tumor present in the surgically removed material). The other is that arms cannot be compared as the treatment arm delays surgery while the placebo arm does not.

Clearly this is a huge question one way or the other. OS will of course be many years later if needed.

I suspect that enrollment will indeed take about that 'year' - unless some big pharma with deep pockets signs on an starts opening some doors for them and shaking the 'money tree' to grease the skids. That could speed things up by at least a couple of months.

And yes - the tumor shrinkage and disease regression data will be available, if not collated and easily analyzable within weeks for each patient. Anecdotal data will be available, but getting the data organized enough to critically analyze is going to take time. If whatever CRO or deep pockets supporter is on the ball and organized, that is still likely to take months post the trial being filled. Again - it's going to take somebody organized and that will have money to throw at the problem to speed things up more than that.

I do think that a conditional approval for Multikine, based on beneficial tumor regression data, is possible by sometime in 2026 as well.

It's going to be an interesting ride here in the meantime.
Have a good weekend folks.

The trend is your friend. Stock moving up on low volume is a good sign.

Rdneum, appreciate both your posts re price projections & timeline. Agree it’s nice to see something/anything re timeline estimates. Thx!

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My Take on First Berlin Report.

They predict enrollment in new trial will take up to a year.
Once enrollment complete results will be in a matter of weeks to determine reduction of tumors and FDA approval..
Survivability will be Monitored for long term results.
UK and Europe and Canada won't come soon.
Possible Big Pharma partnership to cover trial costs.
Financing needed early 3rd Quarter.
Approvals in 2026.

This is the first mention of timeline for trial and results that I've seen.

From First Berlin Equity Research.
I couldn't copy text.
Keeps Buy Recommendation.
Drops Price Target to $6.20 from $8.40

https://www.more-ir.de/d/30013.pdf

Yes, I saw the same ad last week before the market opened on Thursday. Interesting…

Curious if anyone else caught the Cel-Sci/CVM short commercial ad on CNBC this morning like 8ish EDT? It was v short, like 15s ish, and I was so caught off-guard by it, didn’t really catch what the message was, other than seeing/hearing the cos name, stock symbol etc. It’s the first time I ever saw them do an ad, esp during a prime show like the Squawk Box segment, thought it interesting and wanted to share.

Who would not opt for a no risk immunotherapy treatment which might eliminate, in whole or in part ,some cancer cells prior to undergoing surgery, radiation and/or toxic chemotherapy? My hope and prayer is that this company is successful and that millions of future sufferers will be cured or have their life span increased. The early results of the new limited study may answer the question of whether Multikine will be the new Standard of Care for sufferers of head and neck cancer.

Now that the FDA has approved the new limited Phase 3 study, the company has indicated that there has been interest from new investors, some from Europe, to fund the study. Current market cap is around $70 M. I think that a big Pharma company will step in with a bid when preliminary positive results are announced. Strong buy here.

Final protocol for the 212 patient study has or will be submitted to the FDA for approval in the near future. The trial population, since it now will include people who have not yet had but are awaiting surgery, should take less than 6 months. With little downside or side effects from administration of Multikine, it hopefully will be considered a essential standard of care treatment.

Probably not quite that long of a timeline I would guess. Is this going to be another 5 years for test to complete and 2 or 3 years to analyze? With a smaller and more focused test population, and with a big part of the drug efficacy assessment this time for the follow-up trail able to be assessed within months post-treatment, I am guessing less than a year to get the trail populated once it actually gets rolling. They should have the tumor shrinkage data to analyze within months of the trail being populated.

When’s the next dilution?

Is this going to be another 5 years for test to complete and 2 or 3 years to analyze?

yeah ok clearly

Neither do I LOL

nobody cares what you did with your minuscule 50 shares

Still glad I sold at $1.79. This monkey show was a lesson learned. This stock needs to be de-listed since it is a phony pyramid scheme on wash & repeat.

From Zack's:
CVM: Confirmatory Study Clarity
05/21/2024
By John Vandermosten, CFA

NYSE:CVM

READ THE FULL CVM RESEARCH REPORT

First Quarter Fiscal Year 2024 Update

CEL-SCI Corporation (NYSE:CVM) reported its fiscal second quarter on May 15, 2024 with the submission of its Form 10-Q with the SEC and a press release on the following day. Since our previous update in mid-April, CEL-SCI reported that it had received a nod from the FDA on the design of a confirmatory study allowing it to proceed and announced a new director. Other highlights during the period include the grant of a waiver for pediatric requirements by the European Medicines Agency (EMA) and an article featuring CEL-SCI’s Ligand Epitope Antigen Presentation System (LEAPS) technology in Frontiers in Immunology.

Financial Review

CEL-SCI recognized no revenues for its fiscal second quarter ending March 31, 2023 and incurred operating expenses totaling $7.1 million during the three-month period. This resulted in a net loss available to common shareholders of ($7.2) million, or ($0.14) per share.

For the quarter ending March 31, 2023 versus the same prior year period:

? Expenses for research and development fell 24% to $4.6 million from $6.1 million. Lower Phase III study, employee stock compensation and miscellaneous costs contributed to the decrease;

? General and administrative expenses increased 17% to $2.4 million from $2.1 million on higher consulting fees, employee stock compensation and other miscellaneous expenses;

? Other non-operating items were $14,000 compared to ($8,000) in the prior year;

? Net interest expense of ($0.2) million compared with ($0.2) million was related to lease liabilities and was relatively constant;

? Net loss totaled ($6.7) million versus ($8.0) million or ($0.14) and ($0.18) per share, respectively.

As of March 31, 2024, cash and equivalents totaled $5.3 million. Cash burn for the three-month period amounted to approximately ($9.5) million, up from 2Q:23’s ($7.6) million. During the quarter, CEL-SCI closed on a gross $7.8 million in a common stock offering. CEL-SCI holds no debt on its balance sheet.

CEL-SCI Milestones

? EMA waiver for pediatric requirements – January 2024

? Commissioning of Multikine manufacturing facility – 2024

? Appointment of Mario Gobbo to Board of Directors – April 2024

? Feedback from various regulatory agencies - 2024

? Submission of license application to various agencies – 2024+

? Preparation for Multikine confirmatory trial - 2024

LEAPS Article Published in Frontiers in Immunology

Scientific journal Frontiers in Immunology published an article in its March 2024 issue on CEL-SCI’s LEAPS technology as reported in a March 19th press release. While there are approved treatments for rheumatoid arthritis (RA) including adalimumab and other TNF blockers and JAK inhibitors they do not balance adaptive immune homeostasis. These classes of drugs also present the risk of stimulating other disease. CEL-SCI’s CEL-4000 therapeutic vaccine may be able to treat RA while limiting negative side effects by promoting antigen-specific regulatory rather than inflammatory responses, thereby modulating the immunopathological course of RA. In CEL-SCI’s article entitled Current status of immunological therapies for rheumatoid arthritis with a focus on antigen-specific therapeutic vaccines, the authors discuss in-development and approved products for RA and preclinical data for CEL-4000. CEL-SCI’s candidate is able to redirect autoreactive pro-inflammatory memory T cells towards rebalancing the runaway immune/inflammatory responses that characterize it. The drug’s features require the use of more advanced trial design such as adaptive trials and the use of biomarkers for endpoints. The article concludes by asserting that an antigen-specific immunomodulating vaccine, such as CEL-4000, may deliver therapy for RA without weakening important immune defense mechanisms against microbial infections or cancer.

FDA Confirmatory Study Acceptance

On May 8th, CEL-SCI announced that its selection criteria for populating a confirmatory study and study design was cleared by the FDA. In a recent meeting, the agency indicated that the company may move forward with a confirmatory registration study of Multikine. These patients will be newly diagnosed with advanced primary head and neck cancer with no lymph node involvement (determined via PET scan) and with low PD-L1 tumor expression (determined via biopsy). Statistical analysis indicates that 212 subjects will be required to generate the confirmatory data and the FDA has given its blessing to this design. It will be a randomized controlled trial with two arms. The FDA has cleared the trial within the context of the unmet need for squamous cell head and neck cancer (SCCHN).

Based on a discussion of the path forward with the FDA which was included in a 29 page report, the agency responded in written notes accepting the eligibility criteria. It further acknowledged that the nonclinical data appears sufficient, the stratification factors appear reasonable and CEL-SCI’s approach for product specifications is acceptable. Furthermore, the FDA had no safety objections to further treatment of patients with Multikine.

Similar to the IT-MATTERS study, we anticipate that eligible individuals will have a diagnosis of untreated SCCHN, measurable tumor, normal immune function and no use of immunosuppressives in the previous year among other criteria. Based on the performance in the Phase III trial, further population characteristics for the confirmatory study will include patients with no lymph node involvement of the disease and low PD-L1 tumor expression.



The study design calls for a two arm, two stage, 1:1 randomized controlled trial. The first stage will examine pre-surgical response rates, which can be determined shortly after completion of enrollment. Stage two will assess overall survival (OS) as the primary endpoint. Histopathology biomarkers will also be measured.



In its confirmatory trial, CEL-SCI anticipates that it will need to surpass a hurdle of a 10% improvement in overall survival (OS) and produce a hazard ratio of 0.72 or less to merit approval. In the IT-MATTERS study, the target population achieved a 28.5% improvement in OS and produced a hazard ratio of 0.35.

Later sections in the report provided a summary of Multikine’s mechanism of action, emphasizing its ability to enable a local antitumor response to occur. A review of Multikine’s tumor histopathology was provided along with graphics showing pre-surgical response rates and overall survival for the various groupings of patients.



CEL-SCI’s report concluded with a management summary asserting that the FDA recognized an unmet neet for better therapies and is supportive of the confirmatory trial. It also noted the lack of other approved therapies for SCCHN and the lack of success for other immunotherapies in this indication. Details on timing and cost were not provided; however, we anticipate that the management team is in the planning stages for a new trial along with efforts in the other geographies where CEL-SCI seeks to obtain approval.

By now you should have figured out that the daily short sale volume as reported by Finra is not a very good indicator of present or future stock action. A better investment criteria is looking at actual results and future possibilities based on R&D.
There is only one bet to make on this stock: Does Multikine help people with head and neck cancer survive or live longer than those who do not take this treatment. If the results are positive, this company and its shareholders will be a successful.
As for shorting of stocks, with a price this low few investors, other than Market Makers, are participating. If you think about it, sometimes shorts are positive for investors, since, except for bankruptcy, they eventually have to cover and buy to close the position. Ever hear of a short squeeze.
He who sells what isnt' hisn, mst buy it back or go to end prisn- Daniel Drew.

Tuesday's daily short sale volume was 69.64% (as reported by FINRA) but despite all the manipulations by the shorts, the PPS went up 3.97%! The short borrow fee went up to 13.90% and the short shares availability came down from more than a million to 15'000! With all the facts and clarifications that we got in the latest Letter to Shareholders and the news coming in from EMA, MHRA, Health Canada and FDA, it should just be a matter of time until Multikine will be approved and the heavy manipulation by the shorts will come to an end. To keep the PPS low, the shorts still have a position of currently 6.7 million shorted shares (short float of 12.75%). I am so happy for all the cancer patients who will hopefully soon be able to profit from Multikine! GLTAL!! Tick tock, tick tock...

That I believe is exactly what Geert has been avoiding all along. He does not want to essentially give away a part of the company for penny’s on the dollar. I believe he’ll do another offering and dilute again. Current shareholders are not going to sell this close to finish line. So he’s giving shareholders ample time to get out

Seeking Alpha Headlines wrong. CVM: Cel-Sci GAAP EPS of -$0.28 misses by $0.15 They report 2nd Quarter EPS of -28 cents per share missing estimates by 15 cents. The -28 cents were for 6 months. Wass this an innocent mistake? Will they correct this.

Agreed - there will need to be some money raised in some way. I'm waiting to see how they chose to do that as well.

I'm hoping that they can find a big-pharma partner who can help underwrite the costs for starting up the trial - in exchange (of course) for some part of the company or some cut from the eventual profits.

Or better yet - a buyout offer. Not just selling more shares at anywhere near the current share prices.

they are definitely going to need more money at some point and I will wait till then to add more shares

You might be a bit optimistic on the 'before the fall' comment for getting full enrollment. Otherwise I agree with your point here.

Back in late 2015, they were enrolling a steadily climbing 25-35 patients per month for the main Phase III trial. They did enroll a total of 340 patients during the whole of 2015 though. Assuming they push as hard as their CRO did in that year, I could see enrollment by end of Q1 of 2025 though. Once enrollment is filled - they should have data for an initial phase 1 (lower case intended) readout of their confirmatory trial by (I would guess) the next quarter.

Also, keep in mind, that the confirmatory trial has a more limited pool of patients than did the world-wide trial BECAUSE they are going to focus in on a subset of the potential patients with their confirmatory trail. I was tracking enrollment fairly closely back in 2015 when I still occasionally wrote summaries on Seeking Alpha. Part of how quickly they can fill a new trial is going to depend on how much human and financial capital they have available to throw at the problem.

https://seekingalpha.com/instablog/1033940-just-one-lab-nerd/4684406-cel-sci-company-cvm-continues-to-slog-forward-in-populating-phase-iii-trial-for-multikine

After the final protocol is submitted to the FDA before June 21, enrollment of the 212 patients ( 106 for the control and 106 for the multikline users), will hopefully be concluded before the fall. Preliminary positive results should be confirmed within a few weeks thereafter according to the company.

Hopefully these events will be publicized. Stock is seriously undervalued and is deserving of a market cap that is tenfold of current prices. Long and strong here as a believer in the technology.

The kicker would be an approval of the MAA in the UK which will make this treatment the Standard of Care on the other side of the pond.

You'll hopefully pardon me if I do not take your advice....... (Let's see......Production facility complete (check).... Getting multinational acceptance for use (check)......)

I did say that. Don't listen to me about CVM. Buy more shares. I may not be a stock guru, but I know chit when I smell it and CVM is chit. 18 years of proof behind me. There is not enough time in life to wait for CVM to make money for bag holders. It is a day trading crock stock.

Don't forget to remind everyone that you lost a staggering $800 after 18 years of investment. Yea, like I'm going to listen to you for advice.
Look on the bright side, you only lost $44 a year.
Oh, by the way, Move On.

To warn others from making my mistake. If more of us did the same, we retail "investors" would not be parted with our hard earned $$$. I have a conscience and for me to stay silent is frowned upon by Jesus our Savior. He implored us to notify our fellow man of dangers. That is why.

If you sold your stock, why are you here?

Reverse split

Dilution (offering)

Rinse & Repeat

Almost 20 years of that same old story in CVM

Take it from someone who initially bought into CVM in 2006

Warning to anyone considering buying this stock. I know of whence I speak.

Muted

Interim results are approved

And it petered out LOL

I should have listened to you Sushi....you knew long before I about this fraud called CVM.

Thanks for the name calling. Typical child. I did NOT sell, because at that time I only had 7 shares. That's why. Multiply $30 X 7 = $210. I still would have lost $700 because I got in 18 years ago before all the dilutions and reverse splits and invested over $900 Then I bought 43 more shares like an idiot, which means I lost more $ than my initial investment because I believed all the BS of CVM. This company is a revolving door of pyramid schemes. You just don't want to believe it. Waste your money. Don't matter to us.

Moron , why didn’t you sell some at $30? Get lost.

Continued Buying - SEC Form 4. CVM Director

On May 8, 2024, Mr. Watson purchased 20,000 shares of restricted stock directly from the Company at the closing price on May 8, 2024, the most recent closing price available.

Stumbled upon this comment on another site - Yahoo Finance. It was on the SQQQ board. What a coincidence ! I was very surprised.

" abbey
51 minutes ago

Could be worse. You could be a long term bag holder of CVM


Reply



Share "

Still glad I sold all 50 shares at $1.69 the other day. It has been 18 years of hell on wheels with this stock. Between dilution and reverse splits it was a continuous loss that whole time. Where does all the money go? Into their pockets. Phase 3 was a prop. without substance. When this goes sub penny I will buy a lottery ticket for chits & giggles. But they will do another reverse split to prevent it and then dilute - rinse & repeat.

Another SEC Form 4 Senior Vice President

On May 8, 2024, Ms. Prichep purchased 8,000 shares of restricted stock directly from the Company at the closing price on May 8, 2024, the most recent closing price available.

It's never a bad sign when the CEO buys a block of shares.

From SEC Form 4.

On May 8, 2024, Mr. Kersten purchased 30,000 shares of restricted stock directly from the Company at the closing price on May 8, 2024, the most recent closing price available.

Gotta agree, this morning we were up over .30 and now down .29. Guess the market is tired of Geerts carnival show.

Feel sorry for those who got in today way over $2.00 : ( I know how it is....