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Looks that way.
Been here for 15+ years. The trial showed some tumors shrank and a few disappeared, so why has not a big pharma attempted a buy out. Is Geert not looking, do they feel it is a scam or is he just happy using it as his personal ATM.
Apparently Mr. Market is very much NOT impressed by this addition to the BOD.
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)
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.
Any news from the annual share holders meeting last week?
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 !!!
It’s up .06 cents….must be an offering AH
Well - we're about half through 'the month' now and we could use some positive news,....
Wow. Well if either of these go anywhere you should be good. I wish you luck my freind.
I have 41k shares of NWBO and unfortunately 30k shares of this pos
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!!
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…
That's what toxic financing will do to ya.....I warned people here years ago.
Not a great day for us shareholders,... I wonder what the 'looming' bad news is that's driving this?
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.
Leaps Technology rising from the dead. New article out.
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.
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.
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.
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.
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
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<10) (via biopsy).
Physicians routinely assess these features at baseline; no extra tests needed. These features make it easy to write a label for Multikine, which is essential for drug approval.
CEL-SCI estimates that low PD-L1 patients represent about 70% of locally advanced primary SCCHN patients.
In manufacturing, a major issue was the U.S. government’s rules prioritizing companies that make COVID products to receive medical supplies. This caused delays in our work commissioning our Multikine manufacturing facility. Fortunately, we were able to finish this critical work in January 2024:
CEL-SCI’s cGMP state-of-the-art dedicated manufacturing facility commissioning was completed, a significant milestone toward a planned Biologics License Application (BLA) with several regulatory agencies for approval of Multikine. The Company’s manufacturing trade secrets, capabilities, and know-how are high-value key strategic assets that are very difficult for others to replicate.
Usually companies pursue only one regulator, presumably because it is a great deal of work to pursue more. Since Multikine is a unique pre-surgical cancer drug, we decided to in parallel talk to the world’s leading regulators: FDA (U.S.), EMA (Europe), MHRA (UK) and Health Canada (Canada). In our discussions so far, we have been well received, and we have been told that clinically our results are very meaningful and promising. Regulators have been responsive and willing to help us. Here is an update of what we can share with you:
CEL-SCI has submitted the target population data and a proposed study protocol for a confirmatory study of 212 patients to the U.S. Food and Drug Administration (FDA) in Q1 2024.
Health Canada advised CEL-SCI to request advance consideration for approval under a Notice of Compliance with Conditions (NOCC) policy.
The United Kingdom’s National Institute for Health and Care Excellence (NICE) selected Multikine to be evaluated as the potential new standard of care for SCCHN. NICE posted a detailed report from the UK’s National Institute for Health and Care Research (NIHR) regarding Multikine, its clinical data, and its potential to become a better standard of care in treating newly diagnosed head and neck cancer in the UK.
The European Medicines Agency’s (EMA) Paediatric Committee granted CEL-SCI a product-specific waiver of strict requirements for commercialization of cancer drugs in the European Union (EU). The waiver is a big step forward for Multikine, as it removes a major hurdle on the path towards commercialization in Europe.
Meetings with the UK regulators and the EMA are expected H1 2024.
New PD-L1 biomarker findings from the Phase 3 study, which have been integrated into the new target population, demonstrated that Multikine significantly increases overall survival in patients with low levels of tumor cell PD-L1 expression. This is in stark contrast to approved checkpoint inhibitors, such as Keytruda and Opdivo, which most often show longer survival in a proportion of patients with a higher level of tumor cell PD-L1 expression, suggesting a combination therapy could boost patient outcomes. CEL-SCI filed a patent for the use of Multikine in tumors expressing low levels of PD-L1.
We also presented new data at a number of leading scientific conferences:
10th European Congress on Head & Neck Oncology (ECHNO) 2023
“Leukocyte Interleukin Injection (LI) immunotherapy followed by radiotherapy extends overall survival (OS) in treatment naïve locally advanced primary squamous cell carcinoma of the head & neck: the IT-MATTERS Study” (Link to data)
European Society for Radiotherapy and Oncology (ESTRO) 2023
“Histopathology population (HPP) confirms Multikine* [Leukocyte Interleukin Injection (LI)] treatment (Tx) outcome in naïve locally advanced primary head & neck squamous cell carcinoma SCCHN)” (Link to data)
American Head and Neck Cancer Society’s (AHNS) 11th Annual International Conference on Head and Neck Cancer 2023
“Tumor cell PD-L1 biomarker confirms Leukocyte Interleukin Injection (LI) treatment (Tx) survival outcome advantage in naive locally advanced primary head & neck squamous cell carcinoma (SCCHN), the IT-MATTERS Study” (Link to data)
European Society for Medical Oncology (ESMO) Annual Congress 2023
“Early response to Neoadjuvant Leukocyte Interleukin Injection (LI) immunotherapy extends overall survival (OS) in locally advanced primary squamous cell carcinoma (SCC) of the head & neck (HN): the IT-MATTERS Study” (Link to data)
CEL-SCI Has All The Ingredients For Approval
We can identify at diagnosis the patients most likely to have pre-surgical responses to Multikine. The survival statistics in this target population are so good that it is hard to imagine how they could be challenged or ignored. Multikine’s safety profile is very favorable compared to other oncology agents. And, we have a manufacturing plant that can make an estimated $2 billion worth of Multikine annually.
CEL-SCI is ready — and we believe patients and doctors are, too. A new drug for our targeted disease (previously untreated locally advanced primary resectable squamous cell carcinoma of the head and neck) has not been approved by the FDA in decades. The current standard of care provides only a 50-50 chance of living past five years. Large companies have tried and failed to improve this figure. Patients desperately need better treatments.
We now have the ingredients for delivering results to investors as well. While the biotech stock market always has its ups and downs, the clinical data will stand firm and drive the final success for CEL-SCI.
CEL-SCI plans to seek approval for immediate patient access to Multikine without waiting on the results of a new trial wherever possible. There are regulatory pathways specifically designed for such approvals that CEL-SCI is pursuing worldwide. These pathways are called “conditional approvals” (or, in the U.S., accelerated approval) which means you can be approved first while a confirmatory study is ongoing and before that study is completed. Our situation—where we have selected a portion of the Phase 3 study for our target population—is precisely why these regulatory pathways were adopted by regulatory bodies, so that patients do not need to wait many years before gaining access to promising drugs that have already been shown to provide clinical benefit.
Thank you for your continued support.
Sincerely,
Geert Kersten
Chief Executive Officer
I disagree that he is bearish
That author is usually fairly bearish - but this article is relatively evenhanded for him/her.
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?
Depends totally on the financing arrangements.
Someone just invested $7.2 MM in CVM. Would they do this if they were not confident in getting to see results?
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!
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.
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.
I don’t think 25-28% is a HUGE discount. Actually pretty normal for a cash raise.
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?
Geert hitting his personal ATM again.
Assuming that the potential buyer would pay a higher price for the shares.....
Well that ain't good for the shareholders
I think they are just too stupid to figure it out. You can dilute with less shares at a higher price…come on man!!
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.
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.
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.
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
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.
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/
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
Nice move today on decent volume. Something brewing??
I had to laugh when I read your post and then saw your “signature” quoting Tolstoy about patience. Lol.
And more nothing and it's almost February,....
It has bounced upwards off support. Wouldn't panic yet.
Cel-Sci Corporation (CVM)
https://www.youtube.com/watch?v=auAihG3rtC4
Multikine® (Leukocyte Interleukin, Injection) is the full name of this investigational therapy, which, for simplicity, is referred to in the remainder of this page as Multikine*.
Multikine, CEL-SCI's lead investigational immunotherapy, is an immunotherapeutic agent that is being developed as a potential first-line treatment for advanced primary head and neck cancer. If it were to be approved for use following completion of CEL-SCI's clinical development program, Multikine would be a different kind of therapy in the fight against cancer; one that appears to have the potential to work with the body's natural immune system in the fight against tumors.CANCER - MULTIKINE
Multikine may also have the potential to be a first in a new class of cancer immunotherapy drugs. It is the first investigational combination immunotherapy thought to have both passive and active immune properties. More...INFECTIOUS DISEASES - L.E.A.P.S.(TM)**
L.E.A.P.S is a patented, T-cell modulation, peptide epitope delivery technology that enables CEL-SCI to design and synthesize proprietary peptide immunogens. L.E.A.P.S. compounds consist of a small T-cell binding peptide ligand linked with a disease-associated peptide antigen.
This new technology has been shown the potential in several animal models to preferentially direct immune response to a cellular (e.g., T-cell), humoral (antibody) or mixed pathway. Diseases for which antigenic epitope sequences have been identified, such as some infectious diseases, cancer, autoimmune diseases, allergic asthma and allergy, and select CNS diseases (e.g., Alzheimer's) may be potential candidates for development using this technology platform. More...* Multikine is the trademark that CEL-SCI has registered for this investigational therapy, and this proprietary name is subject to FDA review in connection with our future anticipated regulatory submission for approval. Multikine has not been licensed or approved for sale, barter or exchange by the FDA or by any other regulatory agency. Similarly, its safety of efficacy has not been established for any use. Moreover, no definitive conclusions can be drawn from the early-phase, clinical-trials data summarized on this page or elsewhere on this website involving the investigational therapy Multikine (Leukocyte Interleukin, Injection). Further research is required, and early-phase clinical trial results must be confirmed in the well-controlled, Phase III clinical trial of this investigational therapy that is currently in progress.
** L.E.A.P.S. is the trademark of CEL-SCI for this investigational platform technology, and this proprietary name is subject to FDA review. No L.E.A.P.S. product has been approved for sale, barter or exchange by the FDA or any other regulatory agency for any use to treat disease in animals or humans. The safety or efficacy of these products has not been established for any use. Lastly, no definitive conclusions can be drawn from these early-phase, preclinical-trials data involving these investigational products
Partnering Philosophy & Corporate Partners
CEL-SCI's partnering philosophy is guided by the belief that any partnership entered into should serve the best interests of:
CEL-SCI is open to any reasonable partnership proposals that will accelerate its being able to bring its medicines to market.
Multikine (Leukocyte Interleukin, Injection) is the full name of this investigational therapy, which, for simplicity, is referred to in the remainder of this page as Multikine*.
CEL-SCI has a unique expertise in the development and manufacture of complex biologics. CEL-SCI is not a company that markets and sells drug products at the current time. Regardless, CEL-SCI believes it will be capable of marketing and selling Multikine on its own for head and neck cancer in both the United States and Europe if and once it is approved by the FDA (or EU regulators). Since its primary target is head & neck cancer surgeons, a rather small audience, CEL-SCI does not believe that a large sales force will be needed to commercialize Multikine, if and once it is approved by the FDA (or EU regulators) following the review of the total Multikine Biologics License Application.
Current Corporate Partners:
a. | Agreement Signed August 2008 | ||
b. | Territory - Israel, Turkey, expanded to also cover Serbia and Croatia in August 2011. | ||
c. | Revenue Share | ||
d. | Website - http://www.tevapharm.com/ |
a. | Agreement Signed November 2000 | ||
b. | Territory - Taiwan, Singapore, Hong Kong, Malaysia, expanded to also cover South Korea, the Philippines, Australia and New Zealand in the Fall of 2008. | ||
c. | Revenue Share | ||
d. | Website - http://www.oep.com.tw/ |
a. | Agreement signed August 2011 | ||
b. | Territory - Argentina and Venezuela | ||
c. | Revenue Share | ||
d. | Website - http://www.gp-pharm.com/ |
Based on the Company's L.E.A.P.S.TM** technology, as long as a disease epitope is available, CEL-SCI may be able to develop an effective treatment/vaccine using the L.E.A.P.S. technology. The two leading candidates derived from this technology are the H1N1 treatment being developed as a possible treatment option for hospitalized patients and the Rheumatoid Arthritis treatment vaccine currently being tested in animal models of the disease.
* Multikine is the trademark that CEL-SCI has registered for this investigational therapy, and this proprietary name is subject to FDA review in connection with our 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. Moreover, no definitive conclusions can be drawn from the early-phase, clinical-trials data summarized on this page or elsewhere on this website involving the investigational therapy Multikine (Leukocyte Interleukin, Injection). Further research is required, and early-phase clinical trial results must be confirmed in the well-controlled, Phase III clinical trial of this investigational therapy that is currently in progress.
** L.E.A.P.S. is the trademark of CEL-SCI for this investigational platform technology, and this proprietary name is subject to FDA review. No L.E.A.P.S. product has been approved for sale, barter or exchange by the FDA or any other regulatory agency for any use to treat disease in animals or humans. The safety or efficacy of these products has not been established for any use. Lastly, no definitive conclusions can be drawn from these early-phase, preclinical-trials data involving these investigational products.
http://stockcharts.com/h-sc/ui?s=CVM&p=D&yr=3&mn=0&dy=0&id=p60195179833http://stockcharts.com/freecharts/gallery.html?CVM
http://finance.yahoo.com/q?s=cvm&ql=1
https://frugalnorwegian.com/cvm Insight into CVM P3 Trial Results
https://www.cvmresearch.com Insight into CVM P3 Trial Results & FDA Chances of Approval
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