First Berlin Equity Research has published a research update on CEL-SCI Corporation (ISIN: US1508376076). Analyst Christian Orquera reiterated his BUY rating and maintained his USD 8.40 price target.

CEL-SCI announced that it has completed commissioning of its US manufacturing facility for Multikine, its lead drug candidate for advanced primary (newly diagnosed) head and neck squamous cell carcinoma (HNSCC). We anticipate the company will complete the pending validation of the facility in H1 2024. These two steps are crucial for the drug candidate’s Biologics License Application (BLA) for registration. CEL-SCI is currently awaiting confirmation from the UK regulatory authority MHRA that it will accept a conditional approval pathway for Multikine, as the Canadian authority has proposed. We expect a positive response in H1 2024, which would allow for filing in Canada and the UK in H2 2024. These events will be an important catalyst for CEL-SCI’s share price. FY 22/23 financial results were roughly as expected. On 13 February 2024, the company completed the placement of 3.9m shares at USD 2.0 p/s, raising USD 7.75m and extending the cash runway into Q3 2024. Based on unchanged estimates, our sum-of-the-parts valuation model still yields a price target for CEL-SCI of USD 8.40. We maintain our Buy recommendation.