drkazmd65
2 días hace
Another PR about somebody else's work - Yes - We get it - immunotherapies are the wave of the cancer treatment future.
https://feeds.issuerdirect.com/news-release.html?newsid=4713114611511202&symbol=CVM
April 8, 2025 9:51 AM
New Study in the Scientific Journal "Cancer Cell" Supports CEL-SCI's Strategy to Seek Early Approval for Multikine in Head and Neck Cancer Based on Pre-Surgical Tumor Responses
Head and neck cancer patients treated with Multikine who had complete or partial tumor responses before surgery had improvements in overall survival, suggesting pre-surgical tumor response is a strong indicator of efficacy and leads to improved overall survival
A third-party head and neck cancer study published in “Cancer Cell” confirms the observation that pre-surgical tumor responses in head and neck cancer leads to improved survival
CEL-SCI Corporation (NYSE American: CVM) today announced that a study titled “Distinct CD8+ T cell dynamics associate with response to neoadjuvant cancer immunotherapies” by Li Housaiyin et. al., Cancer Cell (2025) provides support for CEL-SCI’s approach aimed at seeking early regulatory approval for Multikine* (Leukocyte Interleukin, Injection) as a neoadjuvant in the treatment of newly diagnosed previously untreated locally advanced head and neck cancer based on early tumor responses.
The concept that tumor responses predict survival has been acknowledged for many cancer types and has led to accelerated approval of many cancer drugs. The study in Cancer Cell, which had 41 evaluable patients, gives further support that this is also true in the neoadjuvant pre-surgical immunotherapy treatment of head and neck cancer.
“The data from both our completed Multikine neoadjuvant Phase 3 study and the study published in Cancer Cell show that newly diagnosed locally advanced head and neck cancer patients who were treated with immune therapies before surgery and had tumor responses, were also likely to have better overall survival. This is quite logical—when a person’s tumor shrinks in response to immunotherapy treatment before the tumor is removed by surgery—their survival outcome is expected to be better,” stated CEL-SCI CEO Geert Kersten. “We believe that the recent greater availability of peer-reviewed published data specific to neoadjuvant therapy and early tumor response in head and neck cancer supports our development and regulatory efforts.”
CEL-SCI’s 212-patient Confirmatory Registration Study, which has received the FDA’s go-ahead, is designed to verify the statistically significant efficacy and safety results from the Company’s previously completed Phase 3 randomized controlled Multikine trial.
During the Multikine Phase 3 clinical trial, the 5-year survival rate of the target patient population for the confirmatory study increased to 73% when patients were treated with Multikine before surgery vs 45% for control patients who received only the standard of care treatments [Log rank p=0.0015 and a hazard ratio of 0.35 (0.18, 0.65; Wald p=0.0012)].
As a neoadjuvant therapy, Multikine is given to patients right after diagnosis, prior to surgery. In the Phase 3 study, pre-surgery objective early tumor response to treatment with Multikine was confirmed by pathology at surgery. There were 45 objective early responders, of which 5 were complete pathological responders, whose tumors completely disappeared in the Multikine treated group, within the 3-weeks of Multikine treatment. There were zero responders reported in the control group pre-surgery. Pre-surgical responders exhibited a 306% overall survival prolongation and had a significantly lowered death rate -vs- non-responders 22.2% vs 54.1% (2-sided Fisher Exact Test, p
KIPK
5 días hace
EXWANNABE:
Your hope resides on PHILIP leaving the MB??
Sad Man - KARMA..
_____________________________
exwannabe
Re: beartrap12 post# 759107
Friday, April 04, 2025 6:14:45 PM
Post#
759111
of 759162
Hang in there, Flipper. We are close, very close.
Damn, that sounds like the guy in the movie talking to the severely wounded loved one to hold on until they get medical help.
Flip is talking about leaving a message board is all. In reality, probably would be best for most all of us smile
fung_derf
2 semanas hace
In a secondary offering, there's generally no mandatory holding period for the stock. Investors can usually sell their shares freely after the offering, unless there are specific lock-up agreements in place.
Here's a more detailed explanation:
What is a Secondary Offering?
A secondary offering (also known as a follow-on offering) occurs when existing shareholders, rather than the company itself, sell a portion of their shares to the public.
No Mandatory Holding Period:
Unlike an IPO (Initial Public Offering) where there might be lock-up periods for insiders, secondary offerings typically do not impose any restrictions on when investors can sell their shares.
Lock-up Periods:
However, it's important to note that some secondary offerings may have lock-up periods, similar to those seen in IPOs, during which certain investors (like company insiders) are restricted from selling their shares for a specified period.
Timing of Secondary Offerings:
Secondary offerings can be announced and marketed within a few days, which is faster than the process for IPOs.
Dilutive vs. Non-Dilutive:
Secondary offerings can be either dilutive (where the company issues new shares, increasing the total number outstanding) or non-dilutive (where existing shareholders sell their shares, but the total number of outstanding shares remains the same).
exwannabe
2 semanas hace
Yes, 95.1% of the 5 patients who had a complete response had an improved QOL Not even sure what math they used to get such a number, but a subgroup of 5? Really?
RECIST v1.0 criteria were followed [35]. A total of 45 (PR/CR) OERs observed following the 3-week LI treatment regimen prior to surgery, were confirmed at surgery by pathology. Five CRs were reported among 45 responders, confirming tumor shrinkage seen in earlier LI published studies [22, 23]. No OERs were reported in the SOC alone group, consistent with no reported spontaneous tumor regressions in this population in the scientific literature.
Among the five CRs, 95% of all responses were classified as the “good outcome” showing sustained QoL benefit.
Clearly they need another trial to prove efficacy int the risk subgroup. All else is noise.
fung_derf
3 semanas hace
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
3 semanas hace
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.
rdneum
3 semanas hace
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.
drkazmd65
4 semanas hace
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
(703) 506-9460
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Monksdream
4 semanas hace
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