On August 15, 2024 CEL-SCI Corporation (NYSE American: CVM) reported financial results for the quarter ended June 30, 2024, as well as key recent clinical and corporate developments (Press release, Cel-Sci, AUG 15, 2024, View Source [SID1234645952]).
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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.