First Berlin Equity Research has initiated coverage on CEL-SCI Corporation (ISIN: US1508376076). Analyst Christian Orquera’s rating is BUY with a price target of USD 8.40 (€7.70).

CEL-SCI Corporation (CEL-SCI) is a biotech company with a development-stage immunotherapeutic product pipeline focused on cancer. The company’s lead drug candidate, Multikine, is a biological product that contains a mixture of naturally derived and naturally occurring human proteins called cytokines, capable of activating a patient’s immune system to fight and kill cancerous tumours. The drug candidate has been primarily developed as a neo-adjuvant (prior to standard therapy which mostly implies surgical removal of the tumour) immunotherapy for the treatment of various types of solid tumours, the lead indication, primary advanced head and neck squamous cell carcinoma (HNSCC). While Multikine did not meet the primary endpoint of the overall phase 3 trials in 923 patients, it demonstrated superior performance compared to standard of care in the pre-defined low-risk arm (n=380). Moreover, post-hoc data analysis of the whole study showed that the drug candidate achieves an even stronger performance in less sick locally advanced disease patients meeting certain criteria (No lymph node involvement – N0 – and low PD-L1 tumour expression). These patients showed a 73% 5-year survival rate vs 45% for the control group, a 28 percentage point overall survival advantage vs control (p=0.0015). Importantly, 38% of these patients saw pre-surgical responses with Multikine which led to a >32% 5-year absolute overall survival advantage vs control (p=0.0019). Based on this data, we believe CEL-SCI’s lead drug candidate, Multikine, has a good chance of receiving conditional approval in Canada and the UK in H2 2024, followed by Europe and the US in 2025. Subject to approval, the company will be able to commercialise the drug while conducting a confirmatory study. We project sales potential for Multikine in these markets of >USD970m. We expect positive news flow from Multikine’s approval process to add substantial value to CEL-SCI and positively impact the share price. We initiate coverage of CEL-SCI with a Buy rating and a USD8.40 (€7.70) price target.