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Cel Sci Corporation New

Cel Sci Corporation New (CVM)

1.47
-0.04
(-2.65%)
At close: April 23 4:00PM
1.47
-0.04
( -2.65% )
After Hours: 4:15PM

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Key stats and details

Current Price
1.47
Bid
-
Ask
-
Volume
185,870
1.44 Day's Range 1.53
1.04 52 Week Range 3.23
Market Cap
Previous Close
1.51
Open
1.51
Last Trade
1
@
1.46
Last Trade Time
17:22:18
Financial Volume
$ 270,910
VWAP
1.4575
Average Volume (3m)
319,697
Shares Outstanding
52,263,000
Dividend Yield
-
PE Ratio
-2.34
Earnings Per Share (EPS)
-0.62
Revenue
-
Net Profit
-32.37M

About Cel Sci Corporation New

CEL-SCI Corp is a player in the biotechnology sector. It is engaged in the research and development at developing the treatment of cancer and other diseases by using the immune system. The company is focused on activating the immune system to fight cancer and infectious diseases. It is focused on th... CEL-SCI Corp is a player in the biotechnology sector. It is engaged in the research and development at developing the treatment of cancer and other diseases by using the immune system. The company is focused on activating the immune system to fight cancer and infectious diseases. It is focused on the development of Multikine (Leukocyte Interleukin, Injection), investigational immunotherapy under development for the treatment of certain head and neck cancers, and anal warts or cervical dysplasia. Show more

Sector
Biological Pds,ex Diagnstics
Industry
Biological Pds,ex Diagnstics
Website
Headquarters
Centennial, Colorado, USA
Founded
1970
Cel Sci Corporation New is listed in the Biological Pds,ex Diagnstics sector of the American Stock Exchange with ticker CVM. The last closing price for Cel Sci was $1.51. Over the last year, Cel Sci shares have traded in a share price range of $ 1.04 to $ 3.23.

Cel Sci currently has 52,263,000 shares outstanding. The market capitalization of Cel Sci is $75.78 million. Cel Sci has a price to earnings ratio (PE ratio) of -2.34.

CVM Latest News

CEL-SCI Appoints Mario Gobbo to Its Board of Directors

CEL-SCI Corporation (NYSE American: CVM) today announced the appointment of Mario Gobbo to its Board of Directors. Mr. Gobbo has nearly 40 years of banking and corporate finance experience in...

CEL-SCI’s LEAPS Vaccine Offers Promising New Paradigm to Treat Rheumatoid Arthritis: Published in Frontiers in Immunology

CEL-4000 may deliver safe and effective therapy for RA by rebalancing the inflammatory response, without weakening important immune defense mechanisms, risking infections or cancer, as current...

CEL-SCI Corporation Issues Letter to Shareholders

CEL-SCI Corporation (NYSE American: CVM) today issued a letter to its shareholders. This letter will be sent to the Company’s shareholders along with the proxy to the upcoming annual meeting...

CEL-SCI Corporation Reports First Quarter Fiscal 2024 Financial Results

CEL-SCI Corporation (NYSE American: CVM) today reported financial results for the quarter ended December 31, 2023, as well as key recent clinical and corporate developments. Clinical and...

PeriodChangeChange %OpenHighLowAvg. Daily VolVWAP
1-0.1-6.369426751591.571.611.441595921.52648738CS
4-0.21-12.51.681.941.441925371.72153946CS
12-1.38-48.42105263162.853.081.443196972.15114786CS
260.3531.251.123.231.048452131.95466141CS
52-1.09-42.5781252.563.231.045499531.93228338CS
156-21.83-93.690987124523.327.841.047261936.49835118CS
260-4.88-76.85039370086.3540.911.047606839.26427278CS

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CVM Discussion

View Posts
drkazmd65 drkazmd65 6 hours ago
Apparently Mr. Market is very much NOT impressed by this addition to the BOD.
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drkazmd65 drkazmd65 8 hours ago
CEL-SCI Appoints Mario Gobbo to Its Board of Directors
9:00 AM ET 4/23/24 | BusinessWire
VIENNA, Va.--(BUSINESS WIRE)--April 23, 2024--

CEL-SCI Corporation (NYSE American: CVM) today announced the appointment of Mario Gobbo to its Board of Directors.

Mr. Gobbo has nearly 40 years of banking and corporate finance experience in healthcare and energy. His expertise encompasses venture capital and private equity as well as investment banking and strategic advisory services. He has served as an officer or director for a number of companies including several biotech companies: Xcovery, Ocimum/Genelogic and Helix BioPharma. Prior to that, Mr. Gobbo worked in the financial industry for Lazard LLC, Swiss Bank Corporation, the European Bank for Reconstruction and Development, Natixis Bleichroeder, Inc., and International Finance Corporation (the private sector arm of the World Bank). Mr. Gobbo holds a Bachelor of Arts in Organic Chemistry from Harvard College, a Master of Science in Biochemistry from the University of Colorado and an MBA, a Master of Business Economics and a PhD (Management) from the Wharton School of the University of Pennsylvania.

"Mr. Gobbo has a unique background where science and Wall Street interact to create new medicines. He has backed many successful healthcare ventures and he has excellent contacts in that part of finance that is interested in building medical breakthroughs into great companies. We are honored to receive his help in bringing Multikine to market as a treatment for head and neck cancer," stated CEL-SCI CEO Geert Kersten.

Mr. Gobbo commented, "This is an exciting and extremely important moment to join the board of CEL-SCI as it is on the brink of developing a product that will revolutionize certain head and neck cancer therapies and probably other deadly cancers. I am proud and honored to become part of the CEL-SCI team."

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* (Leukocyte Interleukin, Injection) 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. In a Phase 3 study, CEL-SCI studied patients who were newly diagnosed with locally advanced primary squamous cell carcinoma of the head and neck (oral cavity and soft-palate) with the investigational product Multikine administered first, before they received the standard of care, which involved surgery followed by either radiation or chemoradiation. The Phase 3 study enrolled 928 patients. Our approach is unique because most other cancer immunotherapies are administered only after conventional therapies have been tried and/or failed.

After analyzing data from the Phase 3 study, we have better defined the target head and neck cancer population for Multikine, which is advanced primary head and neck cancer patients with no lymph node involvement and with low PD-L1 tumor expression. In the Phase 3 study, we observed statistically significant survival data in the final target population, showing that Multikine cut the risk of death in half at five years vs control.

Multikine (Leukocyte Interleukin, Injection) received Orphan Drug designation from the FDA for neoadjuvant therapy in patients with squamous cell carcinoma (cancer) of the head and neck.

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. Such statements include, but are not limited to, statements about the terms, expected proceeds, use of proceeds and closing of the offering. 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/20240423365855/en/

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

SOURCE: CEL-SCI Corporation
Copyright Business Wire 2024

> Dow Jones Newswires

April 23, 2024 09:00 ET (13:00 GMT)
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DocKB DocKB 1 day ago
From Zack's:
CVM: Parallel Engagement On Four Fronts
04/15/2024
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 1Q:24 on February 7, 2024 with the submission of its Form 10-Q with the SEC followed by a press release. Subsequently, news was released regarding its secondary LEAPS candidate, a capital raise and the manufacturing facility. In the European Union, CEL-SCI was granted a waiver of pediatric requirements. Last December, Multikine was evaluated as a new standard of care in the UK. Health Canada advised the company to request advance consideration and, along with the FDA, was awaiting target population data. CEL-SCI has also commissioned its Multikine manufacturing facility near Baltimore, Maryland and raised additional funds in a public offering. The LEAPS vaccine program also had a day in the sun as a paper examining the candidate’s role in rheumatoid arthritis was published in Frontiers of Immunology.

Financial Review

CEL-SCI recognized no revenues for its fiscal first quarter ending December 31, 2023 and incurred operating expenses totaling $6.5 million during the three-month period. This resulted in a net loss available to common shareholders of ($6.7) million, or ($0.14) per share.

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

? Expenses for research and development fell 19% to $4.4 million from $5.4 million. Lower pre-commercialization, Phase III study, and employee stock compensation costs contributed to the decrease;

? General and administrative expenses declined 6% to $2.1 million from $2.3 million on lower consulting fees and employee stock compensation expense partially offset by an increase in miscellaneous administrative expenses;

? Other non-operating items were ($26,000) compared to ($222,000) in the prior year;

? Net interest expense of ($0.2) million compared with ($0.2) million;

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

As of December 31, 2023, cash and equivalents totaled $3.2 million. Cash burn for the three-month period amounted to approximately ($5.0) million, up from last year’s ($4.7) million. In fiscal 2Q:24, CEL-SCI raised approximately $7.8 million in a common stock offering. CEL-SCI holds no debt on its balance sheet.

EMA Waives Pediatric Requirements

As part of its ongoing application process in the EU, CEL-SCI was able to obtain a waiver for conducting further studies in the pediatric population for Multikine in Squamous Cell Carcinoma of the Head and Neck (SCCHN). All applications for marketing authorization for new medicines in the EU must include the results of studies as described in an agreed pediatric investigation plan, unless the medicine is exempt because of a deferral or waiver.

A pediatric waiver from the European Medicines Agency (EMA) allows a pharmaceutical company to be exempt from having to conduct studies in the pediatric population. The main benefit of the pediatric waiver is that it reduces the burden of conducting potentially unnecessary pediatric studies, which can be costly, time-consuming, and may unnecessarily expose children to an investigational medicine. Pediatric waivers are typically granted when the medicine is intended to treat a condition that affects the adult population, the investigational product does not provide a significant benefit to pediatric patients or the disease does not occur in the pediatric population. The waiver will help CEL-SCI avoid substantial time and cost burdens while still allowing Multikine to be used in the target population if approved.

LEAPS Article Published in Frontiers in Immunology

The scientific journal Frontiers in Immunology published an article in its March 2024 issue on CEL-SCI’s Ligand Epitope Antigen Presentation System (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 the disease 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 the disease. 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.
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bluepelican bluepelican 1 day ago
Any news from the annual share holders meeting last week?
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renaissance1 renaissance1 3 days ago
Agreed. Everything and everyone are so quiet lately. What is the next update……it’s been a while. Dying on the vine. LFG CVM!!! It’s time !!!
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PARker1703 PARker1703 4 days ago
It’s up .06 cents….must be an offering AH
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drkazmd65 drkazmd65 1 week ago
Well - we're about half through 'the month' now and we could use some positive news,....
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renaissance1 renaissance1 2 weeks ago
Wow. Well if either of these go anywhere you should be good. I wish you luck my freind.
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PARker1703 PARker1703 2 weeks ago
I have 41k shares of NWBO and unfortunately 30k shares of this pos
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Phoenix2020 Phoenix2020 2 weeks ago
Yesterday's daily short sale volume was 68.62% (as reported by FINRA) but despite all the manipulations by the shorts, the PPS went up 0.56%! The short borrow fee is still at 13.28%! 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 6.97 million shorted shares (short float of 13.34%). The CEO promises us an interesting month: "We are looking forward to a month filled with several very important meetings designed to bring our cancer therapy Multikine to market. We will keep you updated on our progress." I am so happy for all the cancer patients who will hopefully soon be able to profit from Multikine! GLTAL!!
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renaissance1 renaissance1 4 weeks ago
Been in this one for a long time. Same with NWBO. One of these companies has to come to approval at some point… this is taking way too long. Makes me wonder if either is going to actually be a success. I want them both to work out but it is taking alot of patience. Just venting…..maybe we get a miracle this coming week? Praying…
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fung_derf fung_derf 4 weeks ago
That's what toxic financing will do to ya.....I warned people here years ago.
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drkazmd65 drkazmd65 4 weeks ago
Not a great day for us shareholders,... I wonder what the 'looming' bad news is that's driving this?
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Monksdream Monksdream 1 month ago
CVM under $2
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drkazmd65 drkazmd65 1 month ago
I think that LEAPS has a ton of potential. That's a fact. However, LEAPS is a developmental-stage platform that's many years, and lots of $$s away from being anything other than a developmental-stage platform.

If Multikine doesn't pull this company up and start generating revenue, LEAPS will never be more than just a clever idea.
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rdneum rdneum 1 month ago
Leaps Technology rising from the dead. New article out.
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renaissance1 renaissance1 1 month ago
I just read an article on Pfizer’s investor conference:

“Pfizer plans to focus on four main types of cancer: breast cancer; genitourinary cancer, which impacts urinary and genital organs or functions; thoracic cancer, such as lung, head and neck cancer; and hematology-oncology, or cancers of the blood, such as multiple myeloma and lymphomas.”

They also said they are moving away from the lab/small molecule meds and getting into more of the biologics…..

Sorry if this is redundant or old news but it would be nice if they just bought CVM out or at least went into a partnership. CVM appears to be exactly they type of new product they are trying to get in too. What is the hold up?? This is taking a crazy long time.
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drkazmd65 drkazmd65 2 months ago
IMO you're on the right track with your bit about the history of drawn-out finance deals. But I would assert that in addition the long, long, long delays in getting their Phase III rolling soiled the management's reputation. That initial CRO flaking out on them really put a crimp on their getting the trial ramped up - that cost them a couple of years, a lot of both financial and social capital.

Then the study post-treatment period ended up being longer than was stated it would be. Then it took forever to get the data locked, analyzed, and the initial whole-cohort population (as a whole) didn't appear to meet the primary endpoints for success. Then it took them what seemed like years to get the biomarkers for the target subpopulation and the patient assessment criteria in place.

Recent financing of operations has at least been generally transparent. In the past, that definitely could not be said to be true.

They do appear to have at least most of their ducks in a row and marching steadily forward now. That's promising.
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thinkingonlygreen thinkingonlygreen 2 months ago
Yes, i think it has hurt them, however for such a small bio company to stay in business for as long as they have, and accomplish what they have done w/o a big partner is remarkable. You can't build a successful company without a great deal of money. I think we are in the home stretch with the finish line in sight.

Just my opinion of course.
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fung_derf fung_derf 2 months ago
I typically have a great feel for if a company is legit or not, but this one has kept me confused.
The company puts out a great report, however, apparently no one is buying into it.
The only thing that makes any sense at all is all those toxic finance deals they've done in the past are killing them. I don't know if this is still how they are financing their operations.
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drkazmd65 drkazmd65 2 months ago
It's a very positive letter for us shareholders, the company, and potentially for a lot of cancer patients.

It's only a matter of time now. :D
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rdneum rdneum 2 months ago
CEL-SCI Corporation Issues Letter to Shareholders

CEL-SCI Corporation (NYSE American: CVM) today issued a letter to its shareholders. This letter will be sent to the Company’s shareholders along with the proxy to the upcoming annual meeting.

Dear CEL-SCI Shareholders:

Last year we successfully moved our investigational Multikine® (Leukocyte Interleukin, Injection)* cancer therapy forward on the clinical, manufacturing, and regulatory fronts by overcoming several challenges as the biotechnology sector went through very difficult times. The results from our Phase 3 trial presented us with a conundrum in that we had great survival data with Multikine as a pre-surgical treatment in head and neck cancer when followed by surgery and radiotherapy only, but not when followed by surgery, radiotherapy, and chemotherapy. The key issue was how to determine who should be treated with Multikine, which is given before surgery, while the determination of who gets chemotherapy added to their treatment is made after surgery. We solved this issue with great success and presented the selection criteria at a major oncology conference:

CEL-SCI identified the target head and neck cancer patient population for Multikine that will be the basis for the Company’s regulatory filings for marketing clearance. In October 2023, the new data were presented at the 2023 European Society for Medical Oncology (ESMO) Congress. The target population, which saw its 5-year risk of death cut in half, can be identified prior to surgery upon diagnosis with tests that physicians routinely use in cancer screenings, a key finding for Multikine, which is a neoadjuvant therapy. A summary of Multikine’s results in the target population include the following:
Risk of death cut in half at 5 years vs. control
73% survival for Multikine vs 45% in the control at 5 years
28.6% absolute 5-year overall survival benefit versus control; statistically significant p = 0.0015 and hazard ratio = 0.35
Tumor reduction rate >13% and tumor downstaging >35%
Low PD-L1 tumor expression (as compared to high PD-L1 where Keytruda and Opdivo work best)
No safety signals or toxicities vs standard of care
Target population is an estimated 145,000 patients (global, annual) with newly diagnosed squamous cell carcinoma of the head and neck (SCCHN) who present with:

No lymph node involvement (via PET scan)
Low PD-L1 tumor expression (TPS
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hojake97 hojake97 2 months ago
I disagree that he is bearish
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drkazmd65 drkazmd65 2 months ago
That author is usually fairly bearish - but this article is relatively evenhanded for him/her.
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hojake97 hojake97 2 months ago
https://stocktwits.com/NavyPatrol657/message/561244708
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G8TSTFL G8TSTFL 2 months ago
Anyone have access to the 2/12 CVM story on Seeking Alpha? You have to be a Premium member to see it. If so, could you post it here?
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fung_derf fung_derf 2 months ago
Depends totally on the financing arrangements.
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bluepelican bluepelican 2 months ago
Someone just invested $7.2 MM in CVM. Would they do this if they were not confident in getting to see results?
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hogg hogg 2 months ago
You armchair CEO’s are a dime a dozen. Why the hell would he do a huge offering at a 28% discount when they are certain marketing is soon. Smart move would be small incremental steps up the ladder. How the hell did you come up with 40%. What the hell ever anyway , sell button is in same place it always was. Have at it. Or buy up offering yourself!
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fung_derf fung_derf 2 months ago
No....it's a BIG discount! Well maybe in the penny stock world its about right, but can you imagine say GOOG doing an offering at $100 while trading at $150?
Looks like CVM used them last year as well.
If I were a shareholder, I'd sure be looking closer at how the money is being used.
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exwannabe exwannabe 2 months ago
One can debate if a 15% offering was a bit discount. But this was a 40% discount. $2 when the stock was over $2.8 for the last several weeks.

And for a measly $7.2M? Generally when the discounts are large they raise enough cash to live off for a year or more.
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hogg hogg 2 months ago
I don’t think 25-28% is a HUGE discount. Actually pretty normal for a cash raise.
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tigerpac tigerpac 2 months ago
When you can’t borrow from conventional lenders, the offering is usually at a huge discount to current stock price in order to make the deal. It allows the buyer an opportunity to immediately profit if there are no restrictions on the new stock (and it’s totally possible the buyer or some of its affiliates had short positions as this deal was being negotiated) .

For the company, selling shares is a cheaper alternative than paying interest with cash you don’t have (not that any bank will lend additionally to them at this time).

Approval of their drug is the only way out of this mess. Even then, is the market large enough?
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steve2150 steve2150 2 months ago
Geert hitting his personal ATM again.
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Foxwoods Man Foxwoods Man 2 months ago
Assuming that the potential buyer would pay a higher price for the shares.....
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fung_derf fung_derf 2 months ago
You can dilute with less shares at a higher price

Maybe they can't. Dumping company stock isn't going to help you any.

You may want to look into this company. They're the ones who set the price.

https://www.think-equity.com/

This isn't the first time CVM has used them. Perhaps go check on the other companies they've done deals with, to see how the share prices are doing.
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fung_derf fung_derf 2 months ago
Well that ain't good for the shareholders
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BigHeis BigHeis 2 months ago
I think they are just too stupid to figure it out. You can dilute with less shares at a higher price…come on man!!
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drkazmd65 drkazmd65 2 months ago
I absolutely get the need to raise money - but why do the keep undercutting the market by so much when they do so? Ugh.

Might have to use this opportunity to gather in some more shares at a discount next week though.
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RobotDroid RobotDroid 2 months ago
Gerty is famous for screwing the share holders. Looks like he did it again. A $2 offering when the stock was $3. Glad I am on the sidelines here, he has been screwing people for many many years.
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BigHeis BigHeis 2 months ago
CEL-SCI Announces Pricing of $7.75 Million Public Offering of Common Stock
February 09, 2024 08:30 AM Eastern Standard Time
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 an offering of 3,875,000 shares of its common stock at an offering price of $2.00 per share, for gross proceeds of $7.75 million, before deducting underwriting discounts and offering expenses. All of the shares of common stock are being offered by the Company. The offering is expected to close on February 13, 2024, subject to satisfaction of customary closing conditions.

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

ThinkEquity is acting as sole book-running manager 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 prospectus supplement and accompanying prospectus describing the terms of the offering has been or will be filed with the SEC on its website at www.sec.gov. Copies of the prospectus supplement, when available, and the accompanying prospectus relating to the offering may also be obtained from the offices of ThinkEquity, 17 State Street, 41st Floor, New York, New York 10004. Before investing in this offering, interested parties should read in their entirety the prospectus supplement and the accompanying prospectus and the other documents that the Company has filed with the SEC that are incorporated by reference in such prospectus supplement and the accompanying prospectus, which provide more information about the Company and such offering.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.
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drkazmd65 drkazmd65 3 months ago
CEL-SCI Completes Commissioning of Its Multikine Manufacturing Facility for Commercial Scale Production of Head
9:00 AM ET 2/6/24 | BusinessWire

Marks key achievement that is a prerequisite to filing a Biologics License Application with the FDA and other regulators for marketing approval
VIENNA, Va.--(BUSINESS WIRE)--February 06, 2024--

CEL-SCI Corporation (NYSE American: CVM) today reported that its Multikine(R) (Leukocyte Interleukin, Injection)* cGMP state-of-the-art dedicated manufacturing facility commissioning has been completed.

"This is a very significant milestone in bringing Multikine to market since the manufacturing facility is part of a planned Biologics License Application required for approval of Multikine in the treatment of head and neck cancer," stated CEL-SCI's CEO Geert Kersten.

"The high degree of complexity involved in manufacturing Multikine has required tremendous investment and time on CEL-SCI's part. Our manufacturing trade secret, capability, and know-how are high-value key strategic assets that would be very difficult for others to replicate. This achievement marks a very big step towards the preparation of Multikine for marketing approval," Kersten added.

Originally constructed to supply Multikine for the world's largest global pivotal Phase 3 trial in locally advanced squamous cell carcinoma of the head and neck, CEL-SCI's facility has been expanded and upgraded in preparation for the Company's submission of Multikine for regulatory approval and commercial scale manufacturing. In keeping with CEL-SCI Validation Master Plan, industry standards, International Society for Pharmaceutical Engineering (ISPE) guidelines, International Conference for Harmonization (ICH), and in compliance with regulatory guidelines, CEL-SCI undertook commissioning and qualifying the facility's utilities, systems, and equipment.

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. In a Phase 3 study, CEL-SCI studied patients who were newly diagnosed with locally advanced primary squamous cell carcinoma of the head and neck (oral cavity and soft-palate) with the investigational product Multikine administered first, before they received the standard of care, which involved surgery followed by either radiation or chemoradiation. The Phase 3 study enrolled 928 patients. Our approach is unique because most other cancer immunotherapies are administered only after conventional therapies have been tried and/or failed.

After analyzing data from the Phase 3 study, we have better defined the target population, which is advanced primary head and neck cancer patients with no lymph node involvement and with low PD-L1 tumor expression. In the Phase 3 study, we observed statistically significant survival data in the final target population, showing that Multikine cut the risk of death in half at five years vs control. We plan to submit the proposed study protocol to the FDA in Q1 2024, with the goal to get FDA buy-in for a confirmatory clinical trial, and also to discuss potential accelerated approval pathways.

Multikine (Leukocyte Interleukin, Injection) received Orphan Drug designation from the FDA for neoadjuvant therapy in patients with squamous cell carcinoma (cancer) of the head and neck.

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. Such risks and uncertainties include, without limitation, risks and uncertainties associated with (i) the progress and timing of, and the amount of expenses associated with, our research, development and commercialization activities for our product candidates, including Multikine; (ii) our ability to duplicate the clinical results demonstrated in clinical studies, (iii) the timely development of any potential products that can be shown to be safe and effective, (iv) receiving necessary regulatory approvals, (v) difficulties in manufacturing any of the Company's potential products, (vi) our liquidity and ability to raise the necessary capital on acceptable terms, if at all. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company's filings with the Securities and Exchange Commission (SEC), including our Annual Report on Form 10-K for the fiscal year ended September 30, 2023 filed with the SEC on December 21, 2023 and the other reports we will with the SEC. You are urged to read these documents free of charge on the SEC's web site at http://www.sec.gov. The Company encourages you to consider all of these risks, uncertainties and other factors carefully in evaluating the forward-looking statements contained in this press release. As a result of these matters, changes in fact, assumptions not being realized or other circumstances, the Company's actual results may differ materially from the expected results discussed in the forward-looking statements contained in this press release. The forward-looking statements made in this press release are made only as of the date of this press release, and the Company undertakes no obligation to update them to reflect subsequent events or circumstances.

* 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/20240206088192/en/

CONTACT: Gavin de Windt

CEL-SCI Corporation

(703) 506-9460

SOURCE: CEL-SCI Corporation
Copyright Business Wire 2024
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fung_derf fung_derf 3 months ago
I dunno. I'm not a shareholder or planning to buy any shares. Just a somewhat interested observer.
From what I've seen of the past, there have been many fake outs and lost promises.
I'm too lazy on this one to make the effort to truly determine if it's a real company or not.
With that said, currently they are going to continue to lose a lot of money per share for quite some time, but technically, there is no resistance until (I'll say) somewhere just over $7.
Personally, I'm not a buyer of stocks that lose money.
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BigHeis BigHeis 3 months ago
NEWS OUT- causing stock to be “in-play” and going up

https://feeds.issuerdirect.com/news-release.html?newsid=7643495042413725

European Medicines Agency Grants CEL-SCI a Waiver of Strict Pediatric Requirements, Clearing the Path Towards Marketing Authorization for Multikine®
CEL-SCI has cleared a significant hurdle that mandates cancer drugs in Europe comply with strict requirements for pediatric usage and clinical evidence

CEL-SCI Corporation (NYSE American: CVM) today announced that the European Medicines Agency (EMA) Paediatric Committee granted CEL-SCI a product-specific waiver of strict requirements for commercialization of cancer drugs in the European Union (EU). According to the opinion letter:

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20240131910101/en/
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fung_derf fung_derf 3 months ago
The volume was back in October. The short term chart does show the potential for a decent move. ...with a stop loss at $2.20
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renaissance1 renaissance1 3 months ago
Nice move today on decent volume. Something brewing??
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renaissance1 renaissance1 3 months ago
I had to laugh when I read your post and then saw your “signature” quoting Tolstoy about patience. Lol.
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drkazmd65 drkazmd65 3 months ago
And more nothing and it's almost February,....
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fung_derf fung_derf 3 months ago
It has bounced upwards off support. Wouldn't panic yet.
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PARker1703 PARker1703 3 months ago
As soon as I bought this is goes down
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