CEL-SCI Corporation Reports Second Quarter Fiscal 2024 Financial Results

Rhea-AI Summary

CEL-SCI (NYSE American: CVM) reported its Q2 fiscal 2024 financial results. Key clinical and corporate developments included FDA approval for a confirmatory Registration Study of Multikine in head and neck cancer, following strong Phase 3 results with a 28% survival benefit at 5 years. The new study will enroll 212 patients.

Financial highlights for the period ending March 31, 2024: R&D expenses decreased by $2.5M to $9M, G&A expenses increased slightly to $4.6M, and net loss narrowed by $2.2M to $14M. CEL-SCI also raised $7.75M through a public stock offering. Other notable developments: completion of a state-of-the-art manufacturing facility and a key waiver from the European Medicines Agency for Multikine's commercialization in Europe.

Positive

• FDA approval for Registration Study of Multikine based on strong Phase 3 results.
• Phase 3 study showed a 28% absolute survival benefit at 5 years for Multikine.
• Completion of a state-of-the-art manufacturing facility for Multikine.
• Waiver from the European Medicines Agency, removing a major hurdle towards Multikine's commercialization in Europe.
• R&D expenses decreased by $2.5M, or 22%, to approximately $9M.
• Net loss narrowed by $2.2M, or 14%, to $14M.
• Raised $7.75M through a public offering of common stock.

Negative

• General and administrative expenses increased slightly to $4.6M.
• Net loss remains high at $14M, despite a reduction from the previous period.
• Significant dependency on successful outcomes of clinical trials for future growth.
• Potential shareholder dilution due to recent stock offerings.

Insights

Financial Analyst

CEL-SCI Corporation's financial results for the second fiscal quarter of 2024 offer a blend of positive and negative signals for investors. On the financial front, the reduction in research and development expenses by $2.5 million to $9 million is notable. This decrease could reflect a shift to more efficient operations or the completion of key stages in their development pipeline. While general and administrative expenses increased slightly from $4.4 million to $4.6 million, the overall impact on the company's expenditure appears controlled.

More crucially, the net loss narrowed by $2.2 million to $14 million. This improvement, although still resulting in a substantial loss, indicates that CEL-SCI is managing its finances more effectively. Additionally, $5.3 million of this loss being non-cash expenses suggests that the operational cash flow situation might be healthier than the net loss figure alone would imply.

Another key aspect is the raising of approximately $7.75 million through a public offering. This capital influx should provide CEL-SCI with the liquidity needed to continue its development activities, especially critical as they move forward with their Registration Study for Multikine.

Medical Research Analyst

The recent developments surrounding Multikine are highly significant for CEL-SCI. The FDA's approval to commence a confirmatory Registration Study based on strong Phase 3 results is a pivotal milestone. The fact that the Phase 3 study showed a 28% absolute survival benefit at 5 years and no new safety concerns bodes well for the confirmatory study. The selected patient population, characterized by newly diagnosed advanced primary head and neck cancer with specific biomarkers (no lymph node involvement and low PD-L1 expression), is expected to benefit significantly from Multikine.

Moreover, the requirement to enroll only 212 patients compared to the original 928 in the previous study underscores the robustness of the initial findings. The anticipation of a 10% absolute survival benefit further strengthens confidence in the potential of Multikine to become a pre-surgical standard of care in this patient population.

Yet, investors should consider the inherent risks of clinical trials, including potential delays, unforeseen adverse events and variable patient responses, despite the promising data.

Market Research Analyst

CEL-SCI's advancements in the regulatory landscape are noteworthy. The European Medicines Agency’s Paediatric Committee waiver for Multikine marks a significant step towards commercialization in Europe. This waiver removes substantial regulatory hurdles, potentially accelerating market entry and adoption in the European Union. Furthermore, the completion of the state-of-the-art manufacturing facility positions CEL-SCI well for future production demands, ensuring they can meet market needs promptly upon approval.

In addition, the mention of CEL-4000 in a peer-reviewed journal highlights the broader potential of CEL-SCI's pipeline. As the company demonstrates capabilities in both oncology and immunotherapy for autoimmune diseases, it diversifies its portfolio, potentially stabilizing revenue streams in the long run.

However, market entry timelines, competitive landscape and pricing strategies will be critical factors to monitor as they progress towards commercialization. Investors should weigh these aspects alongside the company's current financial health when considering the overall investment potential.

VIENNA, Va.--(BUSINESS WIRE)-- CEL-SCI Corporation (NYSE American: CVM) today reported financial results for the quarter ended March 31, 2024, as well as key recent clinical and corporate developments.

Clinical and Corporate Developments include:

• In May 2024, CEL-SCI received the go-ahead from the U.S. Food and Drug Administration (FDA) for its confirmatory Registration Study of Multikine* in the treatment of head and neck cancer based on very strong safety and efficacy data from the completed Phase 3 study which enrolled 928 patients. The survival benefit for the target population treated with Multikine vs standard of care alone was so strong and clear that the confirmatory study only needs to enroll 212 people. 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).
  
  According to statisticians, the Registration Study is highly likely to succeed because it aims to confirm prior findings and to show a 10% absolute survival benefit vs control at 5 years following treatment. In the Phase 3 study, Multikine demonstrated the following in the target population:

• 28% absolute survival benefit vs control at 5 years
• Risk of death cut in half compared to control at 5 years
• 73% survival for Multikine vs 45% in the control at 5 years
• No safety signals or toxicities vs standard of care
• More detailed results may be viewed here: LINK

• In February 2024, CEL-SCI’s cGMP state-of-the-art dedicated manufacturing facility commissioning was completed, a significant milestone toward a regulatory approval of Multikine.

• In January 2024, the European Medicines Agency’s Paediatric Committee granted CEL-SCI a product-specific waiver of strict requirements for commercialization of cancer drugs in the European Union. The waiver is a significant step forward for Multikine, as it removes a major hurdle on the path towards commercialization in Europe.

• CEL-4000, CEL-SCI’s LEAPS vaccine technology, was featured in an article titled "Current status of immunological therapies for rheumatoid arthritis with a focus on antigen-specific therapeutic vaccines" published in the peer reviewed journal Frontiers in Immunology. The article articulates how CEL-4000 may deliver a safe and effective therapy for rheumatoid arthritis by rebalancing inflammatory response, without weakening important immune defense mechanisms, risking infections or cancer, as current treatments may.

“We are eager to commence our FDA Registration Study to confirm the remarkable overall survival benefits Multikine delivered for patients in our target population. The FDA has acknowledged the great unmet need in this patient population. Through the wealth of data produced in our Phase 3 trial, we were able to identify the precise selection criteria for patients and the corresponding diagnostics to identify these patients prior to surgery. This achievement paved the way for us to get FDA agreement to conduct a study on what could become a pre-surgical standard of care in head and neck cancer,” stated CEL-SCI CEO, Geert Kersten. “We believe the Registration Study is de-risked, thereby building even more confidence in CEL-SCI and our prospects for Multikine in other solid-tumor cancers.”

Financial Results

Research and development expenses decreased by $2.5 million, or 22%, to approximately $9 million during the six months ended March 31, 2024, compared to $11.5 million for the six months ended March 31, 2023. General and administrative expenses in the six months ended March 31, 2024 were $4.6 million compared to $4.4 million in the six months ended March 31, 2023. During the six months ended March 31, 2024, net loss narrowed by $2.2 million or 14% to $14.0 million, approximately $5.3 million of which are non-cash expenses, from $16.4 million in the prior year period. CEL-SCI raised gross proceeds of approximately $7.75 million through a public offering of common stock during the second fiscal quarter.

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 the completed Phase 3 study, CEL-SCI studied patients who were newly diagnosed with locally advanced primary squamous cell carcinoma of the head and neck 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 for Multikine, which is locally 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 in this 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.

CEL-SCI CORPORATION
CONDENSED STATEMENTS OF OPERATIONS
SIX MONTHS ENDED MARCH 31, 2024 AND 2023
(UNAUDITED)
	2024				2023
Operating expenses:
Research and development	$	8,981,044			$	11,476,034
General and administrative		4,580,791				4,350,761
Total operating expenses		13,561,835				15,826,795
Operating loss		(13,561,835	)			(15,826,795	)
Interest expense, net		(380,397	)			(311,852	)
Other expense		(12,183	)			(57,671	)
Net loss		(13,954,415	)			(16,196,318	)
Modification of warrants		-				(171,552	)
Net loss available to common shareholders	$	(13,954,415	)		$	(16,367,870	)
Net loss per common share – basic and diluted	$	(0.28	)		$	(0.38	)
Weighted average common shares outstanding – basic and diluted		50,228,860				43,513,571

CEL-SCI CORPORATION
CONDENSED STATEMENTS OF OPERATIONS
THREE MONTHS ENDED MARCH 31, 2024 AND 2023
(UNAUDITED)
	2024				2023
Operating expenses:
Research and development	$	4,628,535			$	6,083,488
General and administrative		2,447,413				2,092,758
Total operating expenses		7,075,948				8,176,246
Operating loss		(7,075,948	)			(8,176,246	)
Interest expense, net		(182,701	)			(159,063	)
Other income (expense)		13,758				(7,500	)
Net loss		(7,244,891	)			(8,342,809	)
Net loss available to common shareholders	$	(7,244,891	)		$	(8,342,809	)
Net loss per common share – basic and diluted	$	(0.14	)		$	(0.19	)
Weighted average common shares outstanding – basic and diluted		52,006,442				43,588,381

 

View source version on businesswire.com: https://www.businesswire.com/news/home/20240516626742/en/

Gavin de Windt

CEL-SCI Corporation

(703) 506-9460

Source: CEL-SCI Corporation

FAQ

What were the financial results for CEL-SCI in Q2 fiscal 2024?

CEL-SCI reported a net loss of $14M, a decrease in R&D expenses to $9M, and an increase in G&A expenses to $4.6M.

What is the significance of the FDA approval for CEL-SCI's Registration Study?

The FDA's approval for the Registration Study of Multikine is significant as it is based on strong Phase 3 results showing a 28% survival benefit, positioning Multikine closer to market approval.

How much did CEL-SCI raise through its public stock offering?

CEL-SCI raised approximately $7.75 million through a public offering of common stock.

What is the expected enrollment for the new Multikine Registration Study?

The new Multikine Registration Study is expected to enroll 212 patients.

What were the results from the Phase 3 study of Multikine?

The Phase 3 study of Multikine showed a 28% absolute survival benefit at 5 years, with 73% survival for Multikine-treated patients compared to 45% in the control group.