CEL-SCI Corporation Reports Third Quarter Fiscal 2024 Financial Results

Rhea-AI Summary

CEL-SCI (NYSE American: CVM) reported its Q3 fiscal 2024 financial results and key developments. Highlights include:

1. Positive bias analysis results for Multikine, supporting its role in increasing patient survival.

2. FDA approval for a confirmatory Registration Study of Multikine in head and neck cancer treatment.

3. Presentation at IDDST Congress showcasing Multikine's efficacy in patients with low tumor PD-L1 expression.

4. Board strengthening with new appointments.

5. R&D expenses decreased to $4.7 million from $5.7 million year-over-year.

6. G&A expenses reduced to $2.0 million from $2.5 million year-over-year.

7. Post-quarter equity fundraise of $10.85 million completed on July 29, 2024.

Positive

• FDA approval for confirmatory Registration Study of Multikine in head and neck cancer treatment
• Positive bias analysis results supporting Multikine's role in increasing patient survival
• Multikine showed 73% survival rate vs 45% in control arm at 5 years in target population
• R&D expenses decreased by $1 million year-over-year
• G&A expenses reduced by $0.5 million year-over-year
• Successful equity fundraise of $10.85 million completed post-quarter

Negative

• None.

Insights

Financial Analyst

CEL-SCI's Q3 FY2024 results reveal a reduction in both R&D and G&A expenses compared to the same period last year. R&D expenses decreased from $5.7 million to $4.7 million, while G&A expenses dropped from $2.5 million to $2.0 million. This 17.5% reduction in total expenses could indicate improved cost management or a shift in operational focus.

The company's recent $10.85 million equity fundraise, completed after the quarter-end, significantly bolsters its financial position. This capital injection is important for funding the upcoming confirmatory Registration Study and ongoing operations. However, investors should note that this fundraising may lead to dilution of existing shareholders' stakes.

While the financial results show improved cost control, the lack of revenue information and net income figures in the report makes it challenging to assess the company's overall financial health. Investors should carefully monitor cash burn rate and future financing needs as CEL-SCI progresses with its clinical trials.

Medical Research Analyst

The bias analysis results for CEL-SCI's Multikine are highly significant. The analysis found no bias favoring Multikine, which strengthens the credibility of the observed 28% absolute improvement in 5-year survival rates (73% vs. 45%) in the target population. This is a substantial clinical benefit that could potentially revolutionize head and neck cancer treatment.

The FDA's agreement to a smaller confirmatory study (212 patients) based on these strong results is noteworthy. It suggests confidence in the existing data and could accelerate the path to market. The focus on patients with low PD-L1 expression is particularly interesting, as it targets a group that typically responds poorly to current immunotherapies.

The reported hazard ratio of 0.35 is impressive, indicating a 65% reduction in the risk of death. However, investors should remain cautious as these results need to be replicated in the confirmatory study before any regulatory approval can be considered.

Oncology Expert

The potential of Multikine in head and neck cancer treatment is promising, particularly for patients with low PD-L1 expression. The reported 73% 5-year survival rate in the target population is substantially higher than the 45% in the control group, representing a significant clinical improvement.

The neoadjuvant (pre-surgical) application of Multikine is innovative and could fill a critical gap in current treatment protocols. If confirmed, this approach could reduce the need for aggressive post-surgical treatments, potentially improving patients' quality of life.

However, it's important to note that these results are from a subset analysis of a larger trial. The upcoming confirmatory study will be pivotal in validating these findings. The involvement of key opinion leaders like Dr. Giovanni Selvaggi adds credibility to the project, but investors should remain aware that clinical trial outcomes are never guaranteed.

VIENNA, Va.--(BUSINESS WIRE)-- CEL-SCI Corporation (NYSE American: CVM) today reported financial results for the quarter ended June 30, 2024, as well as key recent clinical and corporate developments.

The table includes detailed results from the bias analysis. (Graphic: Business Wire)

Clinical and Corporate Developments include:

• In July 2024, following the end of the third fiscal quarter, CEL-SCI reported the results of a bias analysis. The bias analysis, a standard process to ensure a trial’s findings are reliable, was conducted in preparation for CEL-SCI’s upcoming confirmatory Registration Study. This study will enroll 212 patients representing the target population for which Multikine had a 5-year survival of 73% vs. 45% in the control group. Detailed data on parameters including patient age, sex, race, tumor locations, and staging demonstrated balance between the treatment and control arms. No bias helping Multikine was found, supporting confidence that Multikine is the reason for the large increase in patient survival.
• CEL-SCI received the go-ahead from the FDA for its confirmatory Registration Study of Multikine in the treatment of head and neck cancer based on strong safety and efficacy data from the completed Phase 3 study which enrolled 928 patients. The FDA agreed with the pre-surgical selection of patients most likely to benefit from Multikine—those with newly diagnosed advanced primary head and neck cancer with no lymph node involvement (determined via PET scan) and with low PD-L1 tumor expression (determined via biopsy). In this target population in the Phase 3 study, Multikine demonstrated a 5-year survival of 73% vs a 45% survival in the control patients as well as a hazard ratio of 0.35.
• Dr. Eyal Talor, CEL-SCI’s Chief Scientific Officer, delivered a presentation titled “Neoadjuvant Immunotherapy for Head and Neck Cancer: Low Tumor PD-L1 Expression - IT-MATTERS – RCT” at the International Drug Discovery Science & Technology (IDDST) 20th Annual Congress in Budapest, Hungary. Highlights of the presentation include:
  • Multikine significantly increases overall survival in patients with low levels of tumor cell PD-L1 expression in contrast to approved checkpoint inhibitors
  • 73% survival for Multikine vs 45% in the control arm at 5 years
  • Statistically significant log rank p = 0.0015
  • 5-year risk of death cut in half from 55% to 27%
  • Hazard ratio = 0.35 (95% CIs [0.19, 0.66])
  • The presentation may be accessed on CEL-SCI’s website at the following LINK
• CEL-SCI strengthened its Board of Directors with the addition of Mario Gobbo and the appointment of Robert Watson as Chairperson of the Board. Mr. Gobbo has nearly 40 years of banking and corporate finance experience in healthcare and energy. Mr. Watson brings extensive expertise in capital formation strategies and partnerships, having negotiated over a half dozen exits and more than $750 million in capital transactions including IPOs, secondary offerings, and debt instruments.
• Key opinion leader, Dr. Giovanni Selvaggi, joined CEL-SCI as a Clinical Advisor. Dr. Selvaggi, who has brought several oncology drugs to market, is a US-based drug developer, cancer researcher, and strategic advisor to big pharma and early-to-late-stage biotech companies. He joins several other top-tier physician consultants and head and neck cancer key opinion leaders who are advisors to CEL-SCI.

“We achieved significant and critical milestones in the third fiscal quarter including receiving the FDA’s green light on our confirmatory Registration Study of Multikine to address a vast unmet need in treating newly diagnosed head and neck cancer. Our data is so strong, and now further validated by the bias analysis, that the FDA has agreed to a 212-person study,” stated CEL-SCI CEO, Geert Kersten. “We believe, as do independent statisticians, that the Registration Study is highly likely to succeed because it aims to confirm prior findings which showed excellent survival benefit.”

Financial Results

Research and development expenses were $4.7 million during the three months ended June 30, 2024, compared to $5.7 million for the three months ended June 30, 2023. General and administrative expenses in the three months ended June 30, 2024 were $2.0 million compared to $2.5 million in the three months ended June 30, 2023. Following the end of the third quarter of fiscal 2024, on July 29, 2024, CEL-SCI closed on an equity fundraise of $10.85 million.

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 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. 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.

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.

CEL-SCI CORPORATION
CONDENSED STATEMENTS OF OPERATIONS
NINE MONTHS ENDED JUNE 30, 2024 AND 2023
(UNAUDITED)
	2024				2023
Operating expenses:
Research and development	$	13,684,204			$	17,203,823
General and administrative		6,547,866				6,804,729
Total operating expenses		20,232,070				24,008,552
Operating loss		(20,232,070	)			(24,008,552	)
Interest expense, net		(571,102	)			(493,522	)
Other expense		(7,801	)			(61,525	)
Net loss		(20,810,973	)			(24,563,599	)
Modification of warrants		(659,456	)			(171,552	)
Net loss available to common shareholders	$	(21,470,429	)		$	(24,735,151	)
Net loss per common share – basic and diluted	$	(0.42	)		$	(0.57	)
Weighted average common shares outstanding – basic and diluted		51,479,454				43,761,395

CEL-SCI CORPORATION
CONDENSED STATEMENTS OF OPERATIONS
THREE MONTHS ENDED JUNE 30, 2024 AND 2023
(UNAUDITED)
	2024				2023
Operating expenses:
Research and development	$	4,703,160			$	5,727,789
General and administrative		1,967,075				2,453,968
Total operating expenses		6,670,235				8,181,757
Operating loss		(6,670,235	)			(8,181,757	)
Interest expense, net		(190,705	)			(181,670	)
Other income (expense)		4,382				(3,854	)
Net loss		(6,856,558	)			(8,367,281	)
Modification of warrants		(659,456	)			-
Net loss available to common shareholders	$	(7,516,014	)		$	(8,367,281	)
Net loss per common share – basic and diluted	$	(0.14	)		$	(0.19	)
Weighted average common shares outstanding – basic and diluted		53,994,384				44,254,363

 

View source version on businesswire.com: https://www.businesswire.com/news/home/20240815767286/en/

Gavin de Windt

CEL-SCI Corporation

(703) 506-9460

Source: CEL-SCI Corporation

FAQ

What were CEL-SCI's (CVM) key financial results for Q3 fiscal 2024?

CEL-SCI (CVM) reported R&D expenses of $4.7 million, down from $5.7 million year-over-year, and G&A expenses of $2.0 million, reduced from $2.5 million year-over-year for Q3 fiscal 2024.

What was the outcome of CEL-SCI's (CVM) bias analysis for Multikine?

The bias analysis for Multikine showed no bias favoring the treatment, supporting confidence that Multikine is responsible for the significant increase in patient survival observed in the study.

What is the status of CEL-SCI's (CVM) confirmatory Registration Study for Multikine?

CEL-SCI (CVM) received FDA approval for its confirmatory Registration Study of Multikine in head and neck cancer treatment, which will enroll 212 patients representing the target population.

What were the survival rates for Multikine in CEL-SCI's (CVM) Phase 3 study?

In the target population of the Phase 3 study, Multikine demonstrated a 5-year survival rate of 73% compared to 45% in the control group, with a hazard ratio of 0.35.