CEL-SCI Corporation recently provided its financial results for the quarter ending June 30, 2024, and shared significant clinical and corporate updates that highlight the company’s progress.
Following the quarter, CEL-SCI conducted a bias analysis to assess the validity of the results from its Multikine treatment for head and neck cancer. This bias analysis is a standard procedure meant to ensure that there is no unintentional skewing of results that might favor the treatment.
The analysis confirmed that there was no bias favoring Multikine, reinforcing the company’s confidence that the treatment is responsible for the substantial survival benefits observed in patients.
This finding is critical as it strengthens the reliability of the data and supports the FDA’s approval for CEL-SCI’s next step, a smaller confirmatory Registration Study.
This upcoming study will enroll 212 patients who meet strict criteria, including newly diagnosed advanced head and neck cancer patients with no lymph node involvement (verified through PET scans) and low PD-L1 tumor expression (determined by biopsy).
These criteria are based on the earlier Phase 3 study, which included 928 patients and showed a 5-year survival rate of 73% for those treated with Multikine, compared to only 45% for the control group.
The Phase 3 study also demonstrated a hazard ratio of 0.35, meaning that the risk of death was reduced by 65% in patients who received Multikine. These impressive results have paved the way for the confirmatory study, which is expected to further validate the effectiveness of Multikine in this specific patient population.
The company believes, as do independent statisticians, that this study is highly likely to succeed, given the strength of the previous findings.
CEL-SCI Adds $750M IPO Strategist and Oncology Expert to Leadership Team
In parallel with the clinical developments, CEL-SCI made notable corporate moves to strengthen its leadership team.
The company appointed Robert Watson as Chairperson of its Board of Directors, bringing his extensive experience in capital formation and corporate strategy, having managed numerous capital transactions and IPOs worth over $750 million.
Additionally, Mario Gobbo, who has nearly four decades of experience in banking and corporate finance within the healthcare and energy sectors, joined CEL-SCI’s Board. These additions to the board signal CEL-SCI’s commitment to building a strong leadership foundation as it moves forward with critical trials and product development.
Furthermore, CEL-SCI added Dr. Giovanni Selvaggi, a key opinion leader in oncology who has successfully brought several oncology drugs to market, as a Clinical Advisor. Dr. Selvaggi brings valuable insights and guidance to CEL-SCI’s efforts to advance cancer treatments, particularly for head and neck cancers.
Multikine Cancer Therapy Achieves 73% 5-Year Survival, Showcased at IDDST
On the scientific front, CEL-SCI’s Chief Scientific Officer, Dr. Eyal Talor, presented the company’s groundbreaking results at the 20th Annual Congress of International Drug Discovery Science & Technology (IDDST) in Budapest, Hungary.
His presentation highlighted how Multikine improves survival rates for head and neck cancer patients with low PD-L1 tumor expression, cutting the risk of death in half compared to the control group.
The presentation reinforced the significant potential of Multikine as a neoadjuvant immunotherapy, demonstrating a 73% survival rate over five years compared to 45% in the control arm.
These results were statistically significant, with a log-rank p-value of 0.0015, further underscoring the treatment’s efficacy. The full presentation is available on CEL-SCI’s website for those interested in more detailed scientific data.
Funding Boost: $10.85M Raised After CEL-SCI Cuts Operating Expenses
Financially, CEL-SCI reported a decrease in its research and development expenses for the quarter, which totaled $4.7 million, compared to $5.7 million during the same period in 2023.
General and administrative expenses also decreased, from $2.5 million in the previous year to $2.0 million for the quarter ending June 30, 2024.
In addition to managing its operating expenses, CEL-SCI successfully raised $10.85 million through equity fundraising in July 2024, providing additional financial support for its ongoing research and clinical programs, including the upcoming confirmatory study.
This funding is a crucial component of CEL-SCI’s strategy to ensure it has the resources to complete its pivotal trials and continue its operations.
Multikine Poised to Revolutionize Cancer Treatment with FDA Orphan Drug Status
CEL-SCI’s main focus remains on developing innovative treatments that boost the patient’s immune system to better fight cancer while it is still intact.
Multikine, the company’s flagship treatment, helps the immune system target the tumor at an early stage, when the immune system is still strong, to improve patient outcomes.
The company has already dosed Multikine in over 740 patients and received Orphan Drug designation from the FDA for treating squamous cell carcinoma of the head and neck. This designation underscores the importance of Multikine in treating a difficult cancer type and represents a significant step forward in cancer immunotherapy.
The upcoming confirmatory Registration Study will focus on a specific group of head and neck cancer patients, which represents more than 100,000 cases annually, highlighting the potential market size and impact of Multikine.
CEL-SCI is optimistic about the future of Multikine, given the strong clinical data and ongoing support from the FDA, and remains committed to bringing this first-line cancer therapy to market.
CEL-SCI Poised for Game-Changing Cancer Breakthroughs with Powerhouse Leadership and Bold Scientific Ambitions
As CEL-SCI moves forward, its strong leadership and scientific support position it to achieve its goal of providing new, effective treatments for patients with head and neck cancer.
The company operates out of its headquarters in Vienna, Virginia, and has additional facilities near Baltimore, Maryland, where its research and development activities continue.
CEL-SCI’s forward-looking statements emphasize the company’s belief in the future success of its clinical programs while acknowledging the risks inherent in drug development, including regulatory hurdles and the need for continued capital to fund its operations.
Read also: CEL-SCI’s Multikine Doubles 5-Year Survival in Head & Neck Cancer and Apple Expected to Launch Smart Ring to Rival Samsung by 2026.
