Cel Sci Corporation (CVM)

[fung_derf]

So huge the stock rocketed up .007!

“We are pleased that the wealth of data resulting from our completed Phase 3 study is now published in this international oncology journal,” stated CEL-SCI’s Chief Scientific Officer, Dr. Eyal Talor

So close! Now, if it could ever get approval.

[drkazmd65]

Yeah - it's definitely NOT bad news and it's great to see some more data published. But this still doesn't address how CVM is planning to fund their confirmatory study.

Share prices are going nowhere good until that plan gets some clarity.

[stocktowatch]

$CVM Big News Out!! CEL-SCI Reports New Data: Treatment with Multikine Resulted in up to 95% Improvement in Quality of Life for Head and Neck Cancer Patients https://finance.yahoo.com/news/cel-sci-reports-data-treatment-130000249.html?soc_src=social-sh&soc_trk=tw&tsrc=twtr

[Banjo50]

I think it should be five cents. I bid 1,000 shares at five cents EACH!!!

[fung_derf]

That was really weird to watch. Was it from a Zoom meeting? I notice it kept jumping back and forth every time either spoke.
It did look like it was produced to further the company

[ducruacuteo11]

Maybe Ergomed will be their partner again. They did some deal years back where they pay for some of the trial expenses.

[ducruacuteo11]

It is a paid promo. I wouldn't put any weight on it. LOL. Been there done that.

[Frenchy2016]

Great interview! Thanks for sharing.
Been in and out of CVM for years now, Lost money but still believing! I just have 55 shares left . just afraid they R/S again. but keeping an eye on it daily and ready to buy more if good news come along!

[stocktowatch]

$CVM Cel-Sci is making waves proving its potential to revolutionize cancer treatment!

[ducruacuteo11]

$4? For real? I just loaded up and will give them one more chance. By yearend, I will call it quit for real this time. Lost over $200K over the past 10 years plus. Crying right now. LOL.

[befast]

At the current downward spiral pace, it will get there some time next week. Surprised to not see a higher volume, the subscribers could pocket 50% in just 2 days

[drkazmd65]

My cost average is down about $4. I would be happy to see just that at this point.

But that's not going to happen unless they get things rolling in the confirmatory study - and IMO - that's unlikely to happen unless they get a partner of some kind that got experience and reasonably deep pockets.

I haven't added any since back in 2022 and can't see adding any more unless they get a 'buddy'.

[ducruacuteo11]

Do you think this will ever get back to $40 per share soon? LOL.

[drkazmd65]

Typical and predictable - 'good news' - 'bad news' pairing of events by CVM.

I honestly hope that they have some big pharma partner waiting in the wings. Somebody to fund that confirmatory study we all need in order to get through the FDA. That's a teensy bit of funding relative to what they are currently burning, and for what they are going to need to be burning once they actually the a study rolling.

[ducruacuteo11]

Well, that was a surprise. The price didn't drop to $.16. Hmm.

[fung_derf]

Maybe, but I can't speak to the medical side as I have no formal knowledge. Toxic financing I understand and this company did it early.....and perhaps again recently. It sure looks like a bad finance deal for the current shareholders

[imanjen13]

Deceptive might have been a bad word choice so I will substitute with the word illusory. You may want to rethink you position that stock suffered from toxic financing instead of failure of the technology.

[fung_derf]

Meanwhile two deceptive news events

What were those?

[imanjen13]

The stock had a failure in its technology years ago when its results fell short of FDA approval. Stock hit an all time high and has continued to fall from there with a need to reverse split to avoid delisting, a strategy that fails most of the time.
Its last hope is the confirmatory trials but it needs to fend off a bk before the trials are concluded. The fact that this only "best effort" modest finance deal is necessary should tell you all you need to know. Meanwhile two deceptive news events permitted MMs to unload in pre market action this last 30 days. Perhaps it will be saved by some early promising preliminary results.

[fung_derf]

So, decided to look into ThinkEquity......They''ve got some current skeletons coming out of their closet.

https://brokercheck.finra.org/firm/summary/20996
https://files.brokercheck.finra.org/firm/firm_20996.pdf
https://www.slcg.com/files/results/Roberts%20v%20ThinkEquity.pdf

https://www.glassdoor.com/Reviews/ThinkEquity-Reviews-E215459.htm

And lastly, if you want to see how well Thinkequity does with the companies they work with. Check out their past dealings
https://www.think-equity.com/transactions (not very well from what I can see)

CEL-SCI Announces Pricing of $2.5 Million Offering
Business Wire3:24 PM Eastern Daylight Time Mar 17, 2025

CEL-SCI Announces Pricing of $2.5 Million Offering

CEL-SCI Corporation (“CEL-SCI” or the “Company”) (NYSE American: CVM), a Phase 3 cancer immunotherapy company, today announced the pricing of a best-efforts offering of 16,000,000 shares of its common stock (or pre-funded warrants (“Pre-Funded Warrants”) in lieu thereof). Total gross proceeds from the offering, before deducting the placement agent’s fees and other offering expenses, are expected to be approximately $2,560,000. The offering is expected to close on March 18, 2025, subject to satisfaction of customary closing conditions.

The Company intends to use the net proceeds from the offering to fund the continued development of Multikine, general corporate purposes, and working capital.

ThinkEquity is acting as sole placement agent for the offering.

[fung_derf]

I have to admit, of all the penny stock scams I've busted, this one has confused me the most. From my research, it seems this company IS legit and just screwed up long ago by getting into some toxic finance deals that held them down. However, surely they should have been able to work their way out of this by now? That was years ago! If their science is all they claim it is and actually moving through phase III, then why can they not find legit financing now and buy their way out of toxicity?
Seems like their CFO (Geert Kersten) or board of directors should have been able to turn things around by now. I'd guess having Geert as both CEO and CFO is a giant mistake.
This was the first penny stock I was ready to admit I was wrong on.........but somehow I haven't been.

?
?
CEL-SCI Reports Fiscal Q1 2025 Financial Results: Multikine Shows Pre-Surgical Tumor Elimination and Regression in Just 3 Weeks
Business Wire 1:30 PM Feb 18, 2025
CEL-SCI Reports Fiscal Q1 2025 Financial Results: Multikine Shows Pre-Surgical Tumor Elimination and Regression in Just 3 Weeks

CEL-SCI Corporation (NYSE American: CVM) today reported financial results for three months ended December 31, 2024, as well as key recent clinical and corporate developments.

“CEL-SCI is very uniquely positioned at this moment as an immuno-oncology company with a vast amount of data from the largest Phase 3 head and neck cancer study ever performed, with statistically significant evidence that our drug can successfully fight cancer and extend lives in head and neck cancer,” stated CEL-SCI CEO, Geert Kersten. “We hope to deliver a new standard of care to patients while substantially transforming our company’s valuation to reflect what we believe to be the intrinsic value of our cancer drug. The statistical analysis shows that our very soon to be initiated small confirmatory Registration Study has a very high chance of success and we will have indications of efficacy as early as 2026. Should the pre-surgical tumor responses mirror what we saw in the Phase 3 data, we believe we will be on the path for accelerated and/or conditional approval for Multikine next year.”

Corporate and Clinical Developments include:

• The U.S. FDA concurred with CEL-SCI’s plan to use of PD-L1 as a biomarker to select patients for a Phase 3 confirmatory trial. The study is designed to confirm the observation in our previous head and neck cancer Phase 3 trial that patients with low PD-L1 expression are most likely to have favorable outcomes from Multikine therapy. These patients, when treated with Multikine in the completed Phase 3 study, had a 5-year survival of 73% vs. 45% in the control group with a p-value of 0.0015. PD-L1 is a widely used biomarker for cancer patient selection for checkpoint inhibitors, which appear to work best for patients with high PD-L1 expression. Since Multikine has been shown to be more effective in patients with low PD-L1 expression, Multikine is uniquely positioned to benefit an estimated 70% of head and neck patients who have low PD-L1 expression.
• The strong data from our completed Phase 3 study and the biological rationale for the use of Multikine in the treatment of head and neck cancer suggest a high likelihood of success for the confirmatory Registration Study. These data and rationale include:
• Multikine shows pre-surgical tumor regression in head and neck cancer in just 3 weeks - confirmed by pathology at surgery:
• Multikine led to significant rates of tumor regression prior to surgery.
• There was no tumor regression observed in the control group that did not receive Multikine.
• Pre-surgical tumor regressions confirmed at surgery forecast survival benefit.
• The patient population for the Registration Study is likely to show significant survival prolongation.
• Phase 3 Registration Study patient population selection is based on:
• Strong statistical significance with respect to overall survival vs controls in 114 patients in the Phase 3 study.
• Analysis of the patients in this group was pre-defined in the statistical analysis plan (SAP).
• Strong biological rationale for the results seen in these patients based on Multikine’s mechanism of action (MOA) which brings about a strong and sustainable immune response and does not require overcoming PD-L1 blockade.
• Ergomed, a clinical research organization (CRO) with a strong track record of fast enrollment and high-quality study delivery, is selected as the CRO for CEL-SCI’s confirmatory Registration Study. Ergomed has been a strategic partner and collaborator with CEL-SCI for over 10 years and was instrumental in successfully completing the prior Phase 3 study.
Financial Results

During the three months ended December 31, 2024, research and development expenses were $4.4 million, approximately the same as the three months ended December 31, 2023. General and administrative expenses for the first quarter of fiscal 2025 were $2.5 million compared to $2.1 million in the first quarter of fiscal 2023. Net loss was $7.1 million for three months ended December 31, 2024 compared to $6.7 million in the prior year period. Cash spent during the quarter was $5.1 million. Net loss per common share narrowed by 21% to $0.11 for the three months ended December 31, 2024, compared to $0.14 for the three months ended December 31, 2023.

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 before surgery, radiation and chemotherapy because that is the 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 740 patients and received Orphan Drug designation from the FDA for neoadjuvant therapy in patients with squamous cell carcinoma (cancer) of the head and neck. Based on the data from the completed randomized controlled Phase 3 study of 928 patients, the FDA concurred with CEL-SCI’s target patient selection criteria and gave the go-ahead to conduct a confirmatory Registration Study which will enroll 212 patients. CEL-SCI will enroll newly diagnosed locally advanced not yet treated resectable 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 about 100,000 patients annually.

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

[fung_derf]

It does sound pretty danged dilutive, doesn't it?
BTW, I haven't verified that. I just based it on the earlier post.

[befast]

If that's what they called non dilutive financing for Phase 3 trials, they have to rewrite their last PR. I guess we were fooled again

[fung_derf]

You may want to check your math....

$2,560,000 divided by 16,000,000 shares works out to .16 per share..before deducting placement fees and other offering expenses

[rdneum]

CEL-SCI Announces Pricing of $2.5 Million Offering

My calculations indicate pricing will be around $15.65 to 15.75.


03:24 PM EDT, March 17, 2025
VIENNA, Va.--(BUSINESS WIRE)-- CEL-SCI Corporation (“CEL-SCI” or the “Company”) (NYSE American: CVM), a Phase 3 cancer immunotherapy company, today announced the pricing of a best-efforts offering of 16,000,000 shares of its common stock (or pre-funded warrants (“Pre-Funded Warrants”) in lieu thereof). Total gross proceeds from the offering, before deducting the placement agent’s fees and other offering expenses, are expected to be approximately $2,560,000. The offering is expected to close on March 18, 2025, subject to satisfaction of customary closing conditions.

The Company intends to use the net proceeds from the offering to fund the continued development of Multikine, general corporate purposes, and working capital.

ThinkEquity is acting as sole placement agent for the offering.

The securities will be offered and sold pursuant to a shelf registration statement on Form S-3 (File No. 333-265995), including a base prospectus, filed with the U.S. Securities and Exchange Commission (the “SEC”) on July 1, 2022, and declared effective on July 15, 2022. The offering will be made only by means of a written prospectus. A final prospectus supplement and accompanying prospectus describing the terms of the offering will be filed with the SEC on its website at www.sec.gov. Copies of the prospectus supplement and the accompanying prospectus relating to the offering may also be obtained, when available, from the offices of ThinkEquity, 17 State Street, 41st Floor, New York, New York 10004.

[Budots]

$CVM CEL-SCI’s Head and Neck Cancer Registration Study Protocol Clears FDA Review—in Talks with Potential Partners Interested in Commercialization of Multikine https://finance.yahoo.com/news/cel-sci-head-neck-cancer-120000661.html

[DocKB]

Nice to see the press coverage and study results now reaching JAMA.
What Keytruda does not cover, Multikine will.
Merck should buy CVM.

[drkazmd65]

What an odd PR - They appear to be talking about somebody else's treatment combo, not anything new with Multikine. So yes - the company may have something useful (we already kind of knew that), but making a claim that somebody else's Phase II results show how valuable Multikine might be in other cases is more than kind of desperate sounding.

https://feeds.issuerdirect.com/news-release.html?newsid=4945889827575948

March 14, 2025 8:30 AM
Journal of the American Medical Association (JAMA) Study Provides Further Evidence that CEL-SCI's Multikine Can Treat Unmet Need in ~70% of Head and Neck Patients Based on PD-L1 Expression

The DEPEND study demonstrates that checkpoint inhibitor nivolumab (Opdivo®) works best with high levels of PD-L1 biomarker, but does not work well with low levels of PD-L1

Multikine* is uniquely positioned in the field as the only oncology drug used as a neoadjuvant that has demonstrated overall survival benefit in head and neck cancer patients whose tumors express low levels of PD-L1

Multikine aims to address a major treatment gap for head and neck cancer patients where about 70% have low PD-L1 expression, in its upcoming confirmatory Registration Trial


CEL-SCI Corporation (NYSE American: CVM) today announced that a third-party study published on March 6, 2025 in JAMA Oncology titled “Neoadjuvant Nivolumab Plus Chemotherapy Followed by Response-Stratified Chemoradiation Therapy in HPV-Negative Head and Neck Cancer: The DEPEND Phase 2 Non-randomized Clinical Trial” provided data that support Multikine’s use as a neoadjuvant treatment in patients with tumors having low PD-L1 expression in its upcoming confirmatory head and neck cancer Registration Trial.

“With these latest findings published in JAMA, industry is taking notice. We believe there is growing interest in Multikine as an advanced clinical stage asset that can prolong life for about 70% of head and neck cancer patients whose tumors have low PD-L1 expression,” stated CEL-SCI’s CEO Geert Kersten.

The DEPEND study evaluated nivolumab as a neoadjuvant immunotherapy in human papilloma virus (HPV)–negative locoregionally advanced head and neck cancer. Nivolumab is already an FDA approved treatment for recurrent metastatic squamous cell carcinoma of the head and neck. The authors of the JAMA publication stated: “Taken together the DEPEND results further support the importance of PD-L1 expression as a predictive biomarker with immunotherapy trials in curative intent setting and may be an important selection criterion in subsequent trials”.

The findings of the DEPEND study are very important and timely. They are similar to the findings in CEL-SCI’s Phase 3 study, namely that PD-L1 inhibitors such as Opdivo work best in patients who have high levels of PD-L1, but do not work well in patients with low or zero levels of PD-L1. Conversely, Multikine, which has a very different mechanism of action, worked best in patients who have low to zero levels of PD-L1. This underscores the potential of Multikine to address a critical unmet need amongst newly diagnosed head and neck cancer patients whose tumors have low PD-L1 expression, representing about 70% of this patient population.

The DEPEND Phase 2 data also confirm the independent findings reviewed by the FDA’s recent Oncologic Advisory Committee meeting (September 2024) on the use of checkpoint inhibitors including blockbuster drugs nivolumab and pembrolizumab, which appear to not work well in patients with low PD-L1 expression. To CEL-SCI’s knowledge, Multikine is the only oncology drug with solid data showing overall survival benefit when used as a neoadjuvant treatment in newly diagnosed locally advanced head and neck cancer patients whose tumors have low PD-L1 expression.

Multikine is an investigational cancer immunotherapy (treatment) given to newly diagnosed head and neck cancer patients before the primary standard of care treatment. CEL-SCI’s confirmatory Registration Trial, which has received the FDA’s go-ahead, will enroll patients with previously untreated resectable disease, stage 3 and 4 head and neck cancer who have low PD-L1 tumor expression and no lymph node involvement. During CEL-SCI’s completed Phase 3 clinical trial, the 5-year survival rate of this target patient population increased to 73% when patients were treated with Multikine before standard of care vs 45% for control patients who received only the standard of care treatments.

About CEL-SCI Corporation

CEL-SCI believes that boosting a patient’s immune system before surgery, radiotherapy and chemotherapy have damaged it, 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), given right after diagnosis and before surgery, has been dosed in over 740 patients and received Orphan Drug designation from the FDA for neoadjuvant therapy in patients with squamous cell carcinoma (cancer) of the head and neck. Based on the data from the completed randomized controlled Phase 3 study, the FDA concurred with CEL-SCI’s target patient selection criteria and gave the go-ahead to conduct a confirmatory Registration Study. The study will enroll 212 newly diagnosed locally advanced primary treatment naïve resectable 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 about 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, 2024. 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/20250314970798/en/

COMPANY CONTACT:
Gavin de Windt
CEL-SCI Corporation
[phone]

[Monksdream]

CVM, new 52 week low

[imanjen13]

Unfortunately it looks like the RS will become a reality by the end of the week. One for ten seems about right for a $3 stock price post split. With some preliminary news of the confirmatory trials due sometime in the Summer, this stock may be bought for $1.50- 2.50 in a few months. Not a bad spec for those who still believe in the technology.

[drkazmd65]

And still a lot of nothing,...

[rbl100]

Whatever happened to rdneum? He's a one stock poster. One and done. So much for his wisdom. Another loser like myself.

[rbl100]

$823.84 to be EXACT !

[rbl100]

I wonder how this one stays on the AMEX with it's share price this low? All I know is I lost $800 from this scam.

[fung_derf]

They did a toxic spiral finance deal some years back that they can't shed.

[Rmdaily]

The way I read it there virtually guaranteed the extension if they want it since they have a product that has a good chance of final phase III approval within a year or so. Also, SEC looks at past stock price manipulation practices (i.e. several reverse splits in a short period of time to maintain price compliance along with other shady practices) of which CVM arguably doesn't have. One reverse split back in 2017 is the only one I'm aware of. All good news for CVM. With that being said, I'm very high on CVM since all it will take is one or two favorable results article from the regulatory study which imo will happen somewhere around June or July maybe Aug to get the stock price back over $1.00. Plus that is about the time they will need more funding from a public offering to carry them through the rest of the year. also sounds like the treatment shows it's effectiveness results in roughly 3 weeks after treatment start. Something will leak out just in time for everything to come to gather. before October.

[imanjen13]

Unfortunately there has been significant reverse split activity in this stock. We will ee in March if there is an "automatic" extension of an additional 180 days before delisting threat gives rise to a reverse split again.

The new of some nice confirmatory results did provide a one day boost to high 60s before it fell back.

[Rmdaily]

You won't hear anything for awhile since the reverse split option isn't really on the table until roughly October 2025. Nasdaq rules state the companies who don't regain share price compliance within 180 days from notification are automatically give a second 180 days to regain listing compliance (for a total of 360 days). (see: Listing Rule 5815(a)(1)(B)(ii)d ) Since the last time CVM closed above 1.00 was around October 11, 2024 they got until October 2025 to get there. With the regulatory study proceeding and no significate reverse split activity in CVM's past, there's no reason for Nasdaq/SEC to not grant the second 180 days. The only thing to look out for are public offerings which CVM has done roughly two to three times per year for the past few years.

[fung_derf]

I've seen you on several boards recently. Seems you're working hard to pump RNAZ. A company that recently has been HEAVILY shorted. Is losing a ton of money and from what I can, is known mostly for reverse splits ( 3 in a year and a half).
What is your purpose again?

[glenn1919]

cvm,,,,,,,,,,,,,,,,,,https://stockcharts.com/h-sc/ui?s=CVM&p=W&b=5&g=0&id=p86431144783

[DocKB]

CVM: Fiscal Year 2024 Results
02/10/2025
By John Vandermosten, CFA

NYSE:CVM

READ THE FULL CVM RESEARCH REPORT

CEL-SCI Corporation (NYSE:CVM) reports fiscal year 2024 financial and operational results. The press release and Form 10-K filing encapsulate a year of preparation for confirmatory registration studies around the globe. CEL-SCI cleared its proposed 212-patient registration study of Multikine with the FDA. This narrowed the population to patients with squamous cell carcinoma of the head and neck (SCCHN) with no lymph node involvement and low PD-L1 tumor expression. A contract research organization (CRO) was selected to run the trial and data was presented from the IT-MATTERS study showing 73% survival for Multikine vs. 45% in the control arm at five years. Outside of the US, the European Medicines Agency (EMA) Pediatric Committee and the United Kingdom’s Healthcare Products Regulatory Agency (MHRA) granted Multikine a pediatric waiver, streamlining the process for obtaining approval in these jurisdictions.

Financial Review

CEL-SCI recognized no revenues for its fiscal year ending September 30, 2024. It consumed $26.4 million in operational expenses generating a net loss of ($27.6) million or ($0.51) per share.

For the year ending September 30, 2024 versus the same prior year period:

Expenses for research and development fell 19% to $18.2 million from $22.5 million. Lower Phase III study, employee stock compensation and miscellaneous costs contributed to the decrease and were partially offset by increases in other research and development costs;
General and administrative expenses decreased 9% to $8.2 million from $9.0 million on lower employee stock compensation and other miscellaneous expenses;
Other non-operating items were $177,000 compared to ($43,000) in the prior year;
Net interest expense was relatively constant at ($0.7) million related to interest income from cash balances and expense from finance leases;
Derivative modifications totaled ($659,000) compared to ($172,000);
Net loss totaled ($27.6) million versus ($32.4) million or ($0.51) and ($0.73) per share, respectively.
As of September 30, 2024, cash and equivalents totaled $4.7 million. Cash burn for the twelve-month period amounted to approximately ($18.9) million, up from 2023’s ($23.2) million. Following the end of the fiscal year, CEL-SCI closed on a gross $5 million stock offering. CEL-SCI holds no debt on its balance sheet. The company estimates that the confirmatory trial will cost $30 million.

FDA Confirmatory Study Acceptance

Last May, CEL-SCI announced that its selection criteria for populating a confirmatory study and study design was cleared by the FDA. In a subsequent meeting, the agency indicated that the company may move forward with a confirmatory registration study of Multikine to evaluate its safety and efficacy in squamous cell head and neck cancer (SCCHN). Acceptable patients will be newly diagnosed with advanced primary SCCHN 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. In November 2024, the FDA and CEL-SCI agreed upon the use of the PD-L1 biomarker to select patients for the trial.

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 to be 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 enrolling 212 subjects. 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.

In a December 12th press release, CEL-SCI explained the biologic rationale for the use of Multikine in the confirmatory registrational head and neck cancer study. The discussion referred to the results from the IT-MATTERS study and emphasized the significant rates of tumor regression before surgery in both the Phase II and Phase III studies and the 73% survival with Multikine vs. a 45% for the control patients not treated with Multikine. Other supporting points include:

Benefit to the patient prior to surgery and when the immune system remains strong;
Statistical significance of p=0.0015 and hazard ratio of 0.35 in 114 patients for overall survival (OS);
Eligible patients have no lymph node involvement and low PD-L1 tumor expression;
No excess toxicity beyond the standard of care.
Links to Previous Reports and Background on Multikine

Summary of ESMO Poster Presentation – discussion of lymph node spread and PD-L1 expression
Review of IT-MATTERS population analysis & overall survival comparison
FDA ODAC Opinion
CEL-SCI Milestones

Giovanni Selvaggi joins CEL-SCI as clinical advisor – June 2024
Presentation at the International Drug Discovery Science & Technology (IDDST) Congress – June 2024
CEL-SCI appoints Robert Watson as Chairperson of the Board – July 2024
Feedback from various regulatory agencies - 2024
Submission of license application to various agencies – 2024+
Grant of pediatric waiver by UK’s MHRA – September 2024
ESMO poster presentation provides new data – September 2024
UK’s MHRA grants pediatric waiver to Multikine – September 2024
Ergomed selected as CRO for confirmatory trial – October 2024
FDA ODAC opines against use of checkpoints in low PD-L1 expression patients – Fall 2024
FDA agrees to use of PD-L1 biomarker in Multikine registration study – November 2024
Full enrollment of confirmatory trial – 2Q:26
Clinical Research Organization (CRO) Selection

CEL-SCI selected Ergomed to serve as its CRO for the upcoming confirmatory registration study of Multikine. Details of the selection were included in an October 1st press release. Ergomed had previously provided CRO services to CEL-SCI for the management of the IT-MATTERS trial. Ergomed will manage the trial globally at multiple sites. The announcement reminded readers that the trial will be a 212-patient study enrolling newly-diagnosed, locally advanced, primary head and neck cancer. It will focus on patients with no lymph node involvement and low PD-L1 tumor expression. The anticipated start of the confirmatory trial is 1Q:25.

Capital Raise

CEL-SCI announced the closing of its $5 million offering on December 31st in a press release. The company sold 16,130,000 shares of stock and pre-funded warrants at $0.31 per share. ThinkEquity served as the placement agent for the transaction.

Summary

CEL-SCI is completing the necessary prerequisites for launching its registrational trial in the United States. The trial design has been completed with plans to enroll 212 subjects that conform to specific biomarkers. The trial will include low-risk patients that are appropriate for radiotherapy but not chemotherapy and with low PD-L1 expression. CEL-SCI has also selected its CRO, Ergomed, which also provided these services for the IT-MATTERS trial. Other positive news for immunotherapies are the opinions shared at the November ODAC meeting. At that meeting, a majority of experts asserted that on the whole checkpoint inhibitors could be harmful for patients with low PD-L1 expression, providing support for alternatives such as Multikine if it is approved.

[imanjen13]

At new 52 week low, it appears to be telegraphing the reverse split in 5 weeks. The confirmatory trial would have to be announced soon and be spectacular to avoid it. Sorry

[rbl100]

That's awesome FD ! Ah speaking of Indian Reservations reminded me.... My father LIVED on their reservations for quite some time and no WHITE man is allowed to do so. Reason being is because my father befriended them and gained their trust. And he lived on there because he had no money to live normally. My father ate out of dumpsters for a time. He would take the discarded old food from restaurants. Must have shamed him to no end to do that. Probably because my father would not take a dime from government handouts.
Oh and that 13 day hell for me was not just in Arizona but across the whole Continental United States. I live in New York and I drove home in a UHAUL with his items. Took me 5 days that should have taken me only 3 at most.

P.S. My father used to come home to New York from Tucson Arizona and make it in only 36 hours. No sleeping and cruising average speed of 110 miles per hour in his '64 Buick. State Trooper once tried to catch him and he had to pull over and wait for the Trooper to catch up LOL. My father asked the Trooper "do you have kids"? Trooper said "yes", my father said "you would risk your life having children just to give me a speeding ticket"? That's not too smart my father told him.

[fung_derf]

I have an Arizona travel story as well. It includes Indian reservations and a cattle stampede

[rbl100]

That one and the story of when my father died in Arizona and I had to retrieve his belongings. That was just about a life and death battle. It was survival in a way after an event occurred. I should say two events. I do have a couple of excellent titles in mind too for a movie. Problem is I don't trust Hollywood. They would steal my life event true story and give me nothing in compensation. Guaranteed that movie would be a blockbuster. Because you could not make this chit up what happened to me in those 13 days of Hell with that trip. It was really really phucked up. After that, I now know what the human mind is capable of thinking. Put it that way. Could not even grieve my father's death properly. As a side note, I am convinced my mother was killed/murdered - at the very least an early demise by euthanasia. Still trying to find a lawyer to take my case for no upfront costs. No luck yet.

[fung_derf]

Well that's true, but a mountain of a man!

[fung_derf]

Geez. Sounds like the makings of a good screenplay. Put in on paper and get your story told

[imanjen13]

That's one man's opinion.

[rbl100]

I will check into that as you said. Maybe one day I will be able to restore my father's car to its former glory a 1964 Buick since I never saw my father much. He was around maybe 20 months in my whole life. Was hoping I would win the lottery by now, but it hasn't happened in the 24 years since he died. My mother is dead too and I am an only child. The only survivor left of my family and family name.
Have to honor my mother though, she raised me all by herself without any help from anyone. That is where the credit goes. I stayed honest and never did drugs. She had no help from my father who became destitute after losing all their money by opening a lounge in 1967 at a cost of $50,000 cash in those days. Put all the money into someone else's building - yes DUMB! Then after losing it all within 6 months and having a nervous breakdown, he stayed in it to try and recoup the $$$. Then he ended up owing $250,000 to the mafia and spent the rest of his life paying them off. So my mother had no support whatsoever and worked 6 days a week basically to raise me and keep us off welfare and out of homelessness. Yep, big money back then. He was a good father but made a truly stupid business decision. Well one day I will be rewarded, just maybe not on this side of eternity.

[fung_derf]

I'm SHOCKED to see this stock has a couple of buy recommendations from real sources. You just don't see that with a .38 stock.
This has been one of the few penny stocks that I've always thought MAY have a real product.....I dunno for sure, but I still say their financing in the past will keep them down.
I think their last reverse split was in 2017....but not sure what their other options are?
Nothing about this stock would give me hope, and yet.....I wouldn't rule anything out.
BTW, "not ruling anything out" is my highest rating I would give to a penny stock.