CEL-SCI Corporation Reports First Quarter Fiscal 2024 Financial Results

Rhea-AI Summary

CEL-SCI Corporation (CVM) reported financial results and key clinical & corporate developments for Multikine® in head and neck cancer patients. Recent data presented at ESMO Congress showed a 73% survival rate with Multikine vs 45% in control, with a 28% absolute survival benefit. Statistically significant results with no safety concerns. Target population identified for regulatory filings, estimated at 145,000 global patients annually.

Insights

Financial Analyst

The reported financial results by CEL-SCI Corporation represent a critical pivot point for investors assessing the company's trajectory. The revelation of a targeted patient population for Multikine, which demonstrated a significant survival benefit in clinical trials, has profound implications for the company's market potential. The estimated target population of 145,000 patients annually provides a tangible metric for market size estimation. The statistically significant improvement in survival rates, coupled with a favorable safety profile, suggests a competitive edge in the biotechnology market. Investors should note the potential for increased revenue streams upon regulatory approval, while also considering the costs associated with the final stages of clinical trials, regulatory filings and marketing efforts.

Medical Research Analyst

The clinical data presented for Multikine indicate a substantial advancement in the treatment of squamous cell carcinoma of the head and neck (SCCHN). A 73% survival rate at 5 years compared to 45% in the control group, with a hazard ratio of 0.35, underscores the therapy's efficacy. The ability to identify the target population with routine diagnostic tests simplifies the potential adoption in clinical practice. Medical professionals and stakeholders should weigh the potential of Multikine to become a standard neoadjuvant treatment against the current therapeutic landscape. Long-term benefits could include improved patient outcomes and reduced healthcare costs associated with advanced cancer treatments.

Oncology Doctor

The identification of a specific patient population with no lymph node involvement and low PD-L1 tumor expression for Multikine therapy is a significant stride in personalized medicine. The therapy's neoadjuvant application, intended to shrink tumors before the main treatment, which in this case is surgery, could revolutionize the standard of care for SCCHN. The data indicating tumor reduction and downstaging are particularly promising, as they may lead to less invasive surgeries and better postoperative outcomes. The medical community should closely monitor the progress of Multikine's regulatory filings, as its approval could herald a new era in head and neck cancer management.

VIENNA, Va.--(BUSINESS WIRE)-- CEL-SCI Corporation (NYSE American: CVM) today reported financial results for the quarter ended December 31, 2023, as well as key recent clinical and corporate developments.

Clinical and Corporate Developments include:

• CEL-SCI identified the target head and neck cancer patient population for Multikine^® (Leukocyte Interleukin, Injection)* 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:
  • 73% survival for Multikine vs 45% in the control at 5 years
  • 28% absolute survival benefit
  • Statistically significant p = 0.0015 and hazard ratio = 0.35
  • Tumor reduction rate >13% and tumor downstaging >35%
  • No safety signals or toxicities vs standard of care
  • Target population of 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

• CEL-SCI issued a comprehensive Letter to Shareholders detailing the data reported on the efficacy of Multikine in the head and neck cancer target patient population

• 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.

• The United Kingdom’s (UK) 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.

• CEL-SCI plans to submit the target population data to the U.S. Food and Drug Administration (FDA) this quarter. Health Canada advised CEL-SCI to request advance consideration for approval under a Notice of Compliance with Conditions (NOCC) policy. Meetings with the UK regulators and the EMA are expected H1 2024.

“Following the identification of our focused patient population, backed by robust efficacy data, we have made progress with global regulators, including in the UK and EU where we expect meetings in the coming months. Our manufacturing facility is fully commissioned and should soon be ready for commercial-scale production,” stated CEL-SCI CEO, Geert Kersten. “We are optimistic about working with regulators to get Multikine to the patients who need it. Statistically significant data demonstrate our target patient population can benefit from a longer life with Multikine.”

Financial Results

The Company incurred a net operating loss of approximately $6.5 million for the three months ended December 31, 2023, approximately $2.6 million of which was non-cash expenses.

During the three months ended December 31, 2023, research and development expenses decreased by approximately $1.0 million, or 19%, compared to the three months ended December 31, 2022. During the three months ended December 31, 2023, general and administrative expenses decreased by approximately $0.1 million, or 6%, compared to the three months ended December 31, 2022.

CEL-SCI raised $5 million in November 2023 and $7.75 million in February 2024, both through public offerings of common stock.

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 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 THREE MONTHS ENDED DECEMBER 31, 2023 AND 2022 (UNAUDITED)
	2023				2022
Operating expenses:
Research and development	$	4,352,509			$	5,392,546
General and administrative		2,133,378				2,258,003
Total operating expenses		6,485,887				7,650,549
Operating loss		(6,485,887	)			(7,650,549	)
Interest expense, net		(197,696	)			(152,789	)
Other expense		(25,941	)			(50,171	)
Net loss		(6,709,524	)			(7,853,509	)
Modification of warrants		-				(171,552	)
Net loss available to common shareholders	$	(6,709,524	)		$	(8,025,061	)
Net loss per common share – basic and diluted	$	(0.14	)		$	(0.18	)
Weighted average common shares outstanding – basic and diluted		48,470,600				43,440,387

 

View source version on businesswire.com: https://www.businesswire.com/news/home/20240215017088/en/

Gavin de Windt

CEL-SCI Corporation

(703) 506-9460

Source: CEL-SCI Corporation

FAQ

What are the recent clinical and corporate developments reported by CEL-SCI Corporation (CVM)?

CEL-SCI reported financial results for Q4 2023 and identified the target head and neck cancer patient population for Multikine, with significant survival benefits.

What were the key findings for Multikine in the target head and neck cancer patient population?

Multikine showed a 73% survival rate vs 45% in control, with a 28% absolute survival benefit. Statistically significant results were observed with no safety concerns.

How many patients are estimated in the target population for Multikine globally?

The target population for Multikine is estimated at 145,000 patients globally annually.

What features make it easy to write a label for Multikine?

Physicians can assess features like no lymph node involvement and low PD-L1 tumor expression at baseline, with no extra tests needed, making it easy to write a label for Multikine.

What is the significance of the recent data presented at the 2023 ESMO Congress for Multikine?

The recent data presented at the ESMO Congress showed significant survival benefits with Multikine in head and neck cancer patients, indicating its potential as a neoadjuvant therapy.

What is the estimated survival benefit with Multikine compared to the control group in the target population?

Multikine showed a 28% absolute survival benefit compared to the control group in the target head and neck cancer patient population.

What is the statistical significance of the results for Multikine in the target population?

The results for Multikine in the target population were statistically significant, with a p-value of 0.0015 and a hazard ratio of 0.35.

Are there any safety concerns associated with Multikine in the target population?

There were no safety signals or toxicities observed with Multikine compared to the standard of care in the target head and neck cancer patient population.