DocKB
2 weeks ago
From Zack's :
CVM: Start Your Engines – FDA Green Lights Confirmatory Registration Study
08/28/2024
By John Vandermosten, CFA
NYSE:CVM
READ THE FULL CVM RESEARCH REPORT
CEL-SCI Corporation (NYSE:CVM) reported its fiscal third quarter on August 15, 2024 with the submission of its Form 10-Q with the SEC and a press release on the following day. Since our previous update for the fiscal second quarter, CEL-SCI has added several new individuals to its ranks, conducted a population analysis and presented data at IDDST for IT-MATTERS and raised additional capital to support the advance of Multikine towards the confirmatory registrational trial.
Financial Review
CEL-SCI recognized no revenues for its fiscal third quarter ending June 30, 2023 and incurred operating expenses totaling $6.7 million during the three-month period. This resulted in a net loss available to common shareholders of ($7.5) million, or ($0.14) per share.
For the quarter ending June 30, 2023 versus the same prior year period:
- Expenses for research and development fell 18% to $4.7 million from $5.7 million. Lower Phase III study, employee stock compensation and miscellaneous costs contributed to the decrease and were partially offset by increased spending to prepare for the confirmatory registration study;
- General and administrative expenses decreased 20% to $2.0 million from $2.5 million on lower consulting fees and employee stock compensation partially offset by other miscellaneous expenses;
- Other non-operating items were $14,000 compared to ($8,000) in the prior year;
- Net interest expense of ($0.2) million compared with ($0.2) million was related to lease liabilities and was relatively constant;
- Modification of warrants totaled ($659,000) compared to zero as several series of warrants received an extension of expiration dates;
- Net loss totaled ($7.5) million versus ($8.4) million or ($0.14) and ($0.19) per share, respectively.
As of June 30, 2024, cash and equivalents totaled $0.4 million. Cash burn for the three-month period amounted to approximately ($4.6) million, up from 3Q:23’s ($5.9) million. Following the end of the quarter, CEL-SCI closed on a gross $10.8 million common stock offering. CEL-SCI holds no debt on its balance sheet.
CEL-SCI Milestones
- Appointment of Mario Gobbo to Board of Directors – April 2024
- Dr. Giovanni Selvaggi joins CEL-SCI as clinical advisor – June 2024
- Presentation at the International Drug Discovery Science & Technology (IDDST) Congress – June 2024
- Neoadjuvant Immunotherapy for Head and Neck Cancer: Low Tumor PD-L1 Expression - IT-MATTERS – RCT
- Presented by Dr. Eyal Talor
- CEL-SCI appoints Robert Watson as Chairperson of the Board – July 2024
- Feedback from various regulatory agencies - 2024
- Submission of license application to various agencies – 2024+
- Preparation for Multikine confirmatory trial - 2024
Post-Reporting Period Capital Raise
CEL-SCI announced the closing of its $10.8 million offering on July 29th in a press release. The company sold 10,845,000 shares of stock and pre-funded warrants at $1.00 per share. ThinkEquity served as the placement agent for the transaction. A post transaction summary identified 3,715,000 shares of common stock and 7,130,000 pre-funded warrants were issued.
Population Analysis
In further review of the IT-MATTERS data, CEL-SCI has conducted a bias analysis that was detailed in a July 26th press release. The analysis was conducted to ensure data quality, improve study validity, inform the interpretation of the data and to guide the upcoming confirmatory registration study. The data on patients’ age, sex, race, tumor location and staging find that the active arm and control arm are similar. It finds that the results in the study are reliable, generate reasonable conclusions and minimize the risk of bias.
The bias analysis was conducted for the Phase III study population of 923 patients with newly diagnosed resectable, locally advanced primary head and neck cancer, as well as the subgroup of 114 patients who had no lymph node involvement and had low PD-L1 tumor expression (determined via biopsy). This is the same population which will be drawn from for CEL-SCI’s upcoming confirmatory registration study.
Summary
Since our previous update, CEL-SCI has reported its latest quarterly financial and operational results, conducted a population analysis on the IT-MATTERS subjects, presented data at IDDST and added new faces to its ranks. CEL-SCI continues the planning for its anticipated confirmatory registrational study and raised an additional $10.8 million in July to further this effort. We maintain our valuation of $7.00.
rdneum
2 months ago
PROSPECTUS SUPPLEMENT SUMMARY
This summary highlights selected information contained elsewhere or incorporated by reference in this prospectus supplement and the accompanying prospectus. This summary does not contain all the information that you should consider before investing in our securities. You should read the entire prospectus supplement and the accompanying prospectus carefully, including “Risk Factors” contained in this prospectus supplement and the accompanying prospectus, the financial statements incorporated by reference in this prospectus supplement and the accompanying prospectus, and the other documents identified under the headings “Where You Can Find Additional Information” and “Incorporation of Certain Information by Reference” in this prospectus supplement, before making an investment decision.
THE OFFERING
Common Stock we are offering
3,715,000 shares of common stock
Pre-Funded Warrants
We are also offering 7,130,000 Pre-Funded Warrants to purchase up to 7,130,000 shares of our common stock, exercisable at an exercise price of $0.01 per share, to those purchasers whose purchase of common stock in this offering would otherwise result in the purchaser, together with its affiliates and certain related parties, beneficially owning more than 4.99% (or, at the election of the purchaser, 9.99%) of our outstanding common stock immediately following the consummation of this offering. The purchase price of each Pre-Funded Warrant is equal to the price per share of common stock being sold in this offering minus $0.01. The Pre-Funded Warrants will be immediately exercisable and may be exercised at any time until exercised in full. See “Description of Pre-Funded Warrants.” This prospectus supplement also relates to the offering of the shares of common stock issuable upon the exercise of such Pre-Funded Warrants.
Common stock outstanding prior to this offering
54,268,229 shares of common stock.
Common stock to be outstanding after this offering
57,983,229 shares of common stock, assuming no exercise of any Pre-Funded Warrants.
NYSE American Symbol and Listing
Our common stock is listed on the NYSE American under the symbol “CVM.” There is no established public trading market for the Pre-Funded Warrants, and we do not expect a market to develop. We do not intend to list the Pre-Funded Warrants on the NYSE American or any other national securities exchange or nationally recognized trading system. Without an active trading market, the liquidity of the Pre-Funded Warrants will be limited. See “Description of Pre-Funded Warrants.”
Use of Proceeds
We estimate that our net proceeds from this offering will be approximately $9,937,000, after deducting the placement agent fees and estimated offering expenses payable by us, and assuming full exercise of the Pre-Funded Warrants. We intend to use the net proceeds from this offering to fund the continued development of Multikine and for general corporate purposes and working capital. See “Use of Proceeds.”
Risk Factors
Investing in our securities involves significant risks. Please read the information contained in or incorporated by reference under the heading “Risk Factors” beginning on page S-13 of this prospectus supplement, and under similar headings in other documents filed after the date hereof and incorporated by reference into this prospectus supplement and the accompanying prospectus.
The number of shares of common stock shown above to be outstanding after this offering is based on 54,268,229 shares outstanding as of July 26, 2024 and excludes:
16,322,110 shares of our common stock issuable upon the exercise of outstanding stock options at a weighted average exercise price of $6.92 per share; and
1,092,470 shares of our common stock issuable upon the exercise of warrants outstanding at a weighted average exercise price of $3.16 per share.
Except as otherwise indicated, all information in this prospectus supplement assumes (i) no exercise of the outstanding options or warrants described above; and (ii) no exercise of any Pre-Funded Warrants in this offering.
rdneum
2 months ago
Over 3.5M shares traded before 9am.
CEL-SCI’s Phase 3 Population Analysis for Upcoming Confirmatory Registration Study in Head & Neck Cancer Demonstrates Well Balanced Patient Population, Confidence in Clinical Results
Multikine, a true first-line cancer immunotherapy, cut the 5-year risk of death by half compared to control in its target population
Bias analysis conducted in preparation for submission of data to regulatory agencies including the FDA for confirmatory registration study
Detailed data on parameters including patient age, sex, race, tumor locations, and staging demonstrate balance between the treatment and control arms, no bias found, supporting confidence in Multikine’s efficacy results
CEL-SCI Corporation (NYSE American: CVM) today reported positive results from a bias analysis conducted for its concluded Phase 3 study of Multikine (Leukocyte Interleukin, Injection)* in the treatment of head and neck cancer. Conducting a bias analysis is a standard process used to identify, assess, and address potential sources of bias that could influence the outcomes and interpretations of study results. The goal of a bias analysis is to ensure that the trial's findings are reliable, the conclusions are valid, and to minimize the risk that bias has distorted the results.
This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20240726306579/en/
The above table includes detailed results from the bias analysis involving the 2 groups, treated vs. control (Graphic: Business Wire)
The above table includes detailed results from the bias analysis involving the 2 groups, treated vs. control (Graphic: Business Wire)
CEL-SCI’s bias analysis concluded that the treatment group demographics and baseline characteristics were comparable for the Multikine treated and control arms of the Phase 3 study. There were no confounding baseline parameters in the Multikine-treated versus control population. No bias was present in the study and none was detected in favor of the investigational product, Multikine. As such, the study data are reliably interpretable, statistically significant and have been shown to support the clinical effect of neoadjuvant (pre-surgery) Multikine immunotherapy in extending the life of these patients in the Phase 3 study.
This is critically important information because CEL-SCI, with the FDA’s agreement, will be conducting a 212-patient confirmatory registration study for Multikine. The target population for the confirmatory study shows a 5-year survival in advanced primary head and neck cancer of 73% in Multikine treated patients vs. 45% survival in the control.
“Multikine’s efficacy results in the target population are truly impressive and the bias analysis is critical to demonstrate a high degree of confidence in the data. A hazard ratio of 0.35 with an upper limit of 0.66 is excellent and suggests a very high chance to repeat the great survival benefit from Multikine. The bias analysis showed that the survival benefit is truly from Multikine as opposed to an imbalance in the patient population,” stated CEL-SCI CEO Geert Kersten. “We are pleased to share the baseline results as we prepare to submit the data to regulators ahead of our upcoming confirmatory registration study.”
The bias analysis was conducted for the entire Phase 3 study population of 923 patients with newly diagnosed resectable, locally advanced primary head and neck cancer, as well as the subgroup of 114 patients who had no lymph node involvement and had low PD-L1 tumor expression (determined via biopsy), the target population for CEL-SCI’s upcoming confirmatory registration study.
About CEL-SCI Corporation
CEL-SCI believes that boosting a patient’s immune system while it is still intact should provide the greatest possible impact on survival. Multikine is designed to help the immune system "target" the tumor at a time when the immune system is still relatively intact and thereby thought to be better able to mount an attack on the tumor.
Multikine (Leukocyte Interleukin, Injection), a true first-line cancer therapy, has been dosed in over 750 patients and received Orphan Drug designation from the FDA for neoadjuvant therapy in patients with squamous cell carcinoma (cancer) of the head and neck. Multikine significantly extended life in its target patient population demonstrating a 73% survival rate with Multikine vs. only 45% without at 5 years after treatment. Based on this very strong data, the FDA agreed to CEL-SCI’s target patient selection criteria and gave the go-ahead to conduct a small, focused, confirmatory Registration Study which will enroll 212 patients. CEL-SCI will enroll newly diagnosed locally advanced primary head and neck cancer patients with no lymph node involvement (determined via PET scan) and with low PD-L1 tumor expression (determined via biopsy), representing over 100,000 patients annually.
The Company has operations in Vienna, Virginia, and near/in Baltimore, Maryland.
Phoenix2020
2 months ago
Thursday's daily short sale volume was 31.36% (as reported by FINRA) and the shorts managed to get the PPS down with their heavy manipulations. However, the short borrow fee is up to 103.91% and the short shares availability came down from more than a million shares to 400 shares that are currently available! With all the expected news coming in from EMA, MHRA, Health Canada and FDA, it should just be a matter of time until Multikine will be approved and the heavy manipulation by the shorts will come to an end. To keep the PPS low, the shorts have increased their position by another 230'000 to currently 8.46 million shorted shares (short float of 16.13%). I am so happy for all the cancer patients who will hopefully soon be able to profit from Multikine! GLTAL!! Tick tock, tick tock...
Phoenix2020
2 months ago
Yesterday's daily short sale volume was 22.30% (as reported by FINRA) but despite all the heavy manipulations by the shorts, the PPS went up 14.5%. The short borrow fee is up to 81.71% and the short shares availability came down from more than a million shares to 40'000 shares that are currently available! With all the expected news coming in from EMA, MHRA, Health Canada and FDA, it should just be a matter of time until Multikine will be approved and the heavy manipulation by the shorts will come to an end. To keep the PPS low, the shorts have increased their position by another 200'000 to currently 8.21 million shorted shares (short float of 15.66%) - up almost 1 million shares since last month. I am so happy for all the cancer patients who will hopefully soon be able to profit from Multikine! GLTAL!! Tick tock, tick tock...
drkazmd65
2 months ago
Change in management - New Chairman - Guy with experience in raising money.
https://feeds.issuerdirect.com/news-release.html?newsid=5946140769547282
July 8, 2024 9:15 AM
CEL-SCI Appoints Robert Watson as Chairperson of the Board
CEL-SCI Corporation (NYSE American: CVM) today announced that Robert (“Bob”) Watson, who has served as a Director of the Company since 2017, has been appointed Chairperson of the Board.
Bob is an accomplished business leader who began his career as an investment banker. With over four decades of experience across various healthcare markets, Bob brings extensive expertise in capital formation strategies and partnerships to drive an efficient capital structure. During his career as CEO or President of private and publicly traded companies in the healthcare sector, Bob negotiated over a half dozen exits and more than $750 million in capital transactions including IPOs, secondary offerings, and debt instruments.
“I have greatly appreciated Bob’s guidance as a Director of CEL-SCI. His recent retirement from an active CEO role created the bandwidth for him to assume additional responsibilities as our Chairperson. The team and I are excited to have Bob involved at this level where his capital markets expertise will be highly valuable,” stated CEL-SCI CEO Geert Kersten.
Based on robust efficacy and safety data in over 750 patients for its immunotherapy drug, Multikine, CEL-SCI received the U.S. Food and Drug Administration’s go-ahead to conduct a confirmatory Registration Study for the treatment of newly diagnosed advanced primary head and neck cancer. Multikine, a true first-line cancer therapy, significantly extended life in its target patient population demonstrating a 73% survival rate with Multikine vs. only 45% without at 5 years after treatment. The small, focused, confirmatory Registration Study will enroll only 212 patients with a high unmet need for an estimated 100,000 patients annually.
Bob Watson commented, “Having been on the path with CEL-SCI toward FDA approval of Multikine, it is my honor to be able to stand side by side with the management team as we complete the final leg of this amazing journey to bring a pre-surgical immunotherapy to patients with head and neck cancer. As stated previously, we are very confident that the Registration Study will confirm the excellent safety and efficacy results demonstrated in prior studies.”
About CEL-SCI Corporation
CEL-SCI believes that boosting a patient’s immune system while it is still intact should provide the greatest possible impact on survival. Multikine is designed to help the immune system "target" the tumor at a time when the immune system is still relatively intact and thereby thought to be better able to mount an attack on the tumor.
Multikine (Leukocyte Interleukin, Injection), a true first-line cancer therapy, has been dosed in over 750 patients and received Orphan Drug designation from the FDA for neoadjuvant therapy in patients with squamous cell carcinoma (cancer) of the head and neck. Multikine significantly extended life in its target patient population demonstrating a 73% survival rate with Multikine vs. only 45% without at 5 years after treatment. Based on this very strong data, the FDA agreed to CEL-SCI’s target patient selection criteria and gave the go-ahead to conduct a small, focused, confirmatory Registration Study which will enroll 212 patients. CEL-SCI will enroll newly diagnosed advanced primary head and neck cancer patients with no lymph node involvement (determined via PET scan) and with low PD-L1 tumor expression (determined via biopsy), representing over 100,000 patients annually.
The Company has operations in Vienna, Virginia, and near/in Baltimore, Maryland.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. When used in this press release, the words "intends," "believes," "anticipated," "plans" and "expects," and similar expressions, are intended to identify forward-looking statements. Such statements are subject to risks and uncertainties that could cause actual results to differ materially from those projected. Factors that could cause or contribute to such differences include an inability to duplicate the clinical results demonstrated in clinical studies, timely development of any potential products that can be shown to be safe and effective, receiving necessary regulatory approvals, difficulties in manufacturing any of the Company's potential products, inability to raise the necessary capital and the risk factors set forth from time to time in CEL-SCI's filings with the Securities and Exchange Commission, including but not limited to its report on Form 10-K for the year ended September 30, 2023. The Company undertakes no obligation to publicly release the result of any revision to these forward-looking statements which may be made to reflect the events or circumstances after the date hereof or to reflect the occurrence of unanticipated events.
* Multikine (Leukocyte Interleukin, Injection) is the trademark that CEL-SCI has registered for this investigational therapy. This proprietary name is subject to FDA review in connection with the Company's future anticipated regulatory submission for approval. Multikine has not been licensed or approved for sale, barter or exchange by the FDA or any other regulatory agency. Similarly, its safety or efficacy has not been established for any use.
View source version on businesswire.com: https://www.businesswire.com/news/home/20240708501317/en/
Gavin de Windt
CEL-SCI Corporation
(703) 506-9460
Phoenix2020
2 months ago
Friday's daily short sale volume was 55.72% (as reported by FINRA) but despite all the heavy manipulations by the shorts, the PPS went up 10.00%. The short borrow fee went up to 85.44% and the short shares availability came down from more than a million shares to only 2000 shares that are currently available! With all the expected news coming in from EMA, MHRA, Health Canada and FDA, it should just be a matter of time until Multikine will be approved and the heavy manipulation by the shorts will come to an end. To keep the PPS low, the shorts have increased their position to currently 8.04 million shorted shares (short float of 15.33%) - up almost 1 million shares since last month. I am so happy for all the cancer patients who will hopefully soon be able to profit from Multikine! GLTAL!! Tick tock, tick tock...
exwannabe
3 months ago
I suspect that enrollment will indeed take about that 'year' - unless some big pharma with deep pockets signs on an starts opening some doors for them and shaking the 'money tree' to grease the skids. That could speed things up by at least a couple of months.
A year would be blazing fast. This indication is about 1/3 the size of the previous trial, so enrollment will be slower. That trial maxed out at about 25/month. I would think 10-15 a month would be reasonable once they get the same number of sites up. But it takes a long time to bring sites up, does not happen in a few months.
I do think that a conditional approval for Multikine, based on beneficial tumor regression data, is possible by sometime in 2026 as well.
That is probably the million dollar question. I would want to see the actual trial design before having a firm opinion, but there are issues here. To my knowledge the only surrogate the FDA has accepted in this area is pCR (pathological complete response, no tumor present in the surgically removed material). The other is that arms cannot be compared as the treatment arm delays surgery while the placebo arm does not.
Clearly this is a huge question one way or the other. OS will of course be many years later if needed.
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