First Berlin Equity Research has published a research update on CEL-SCI Corporation (ISIN: US1508376076). Analyst Christian Orquera reiterated his BUY rating and decreased the price target from USD 186.00 to USD 60.00.
Abstract
CEL-SCI Corporation is approaching a pivotal commercial inflection point in 2025. In mid-August, the company (1) filed for a Breakthrough Medicine Designation (BMD) with the Saudi Food & Drug Authority (SFDA) for Multikine, its lead immunotherapy for head and neck cancer (HNSCC). Approval could be granted within ~60 days?potentially by mid-to-late October?paving the way for early commercialisation in Saudi Arabia. (2) CEL-SCI also signed an MOU with Dallah Pharma, part of the prestigious Dallah Healthcare Group. As one of Saudi Arabia’s leading pharmaceutical companies, Dallah offers the regulatory expertise, government access, and nationwide reach needed to maximise Multikine’s sales potential. Partnering with a company of Dallah’s calibre strongly validates Multikine’s value and commercial promise. In parallel, the US FDA has approved the protocol for CEL-SCI’s confirmatory registration study in HNSCC, positioning the trial to start in CY H2 2025, subject to funding (FBe: USD30m). On the financial side, CEL-SCI raised USD12.6m in CY H1 2025 plus additional USD15.9m in July/August and executed a 1-for-30 reverse split to maintain NYSE compliance. The financial position has improved slightly as the cash runway has been extended until approximately summer 2026. Importantly, the Saudi commercialisation is expected to open doors for further funding. We have updated our SOTP model to incorporate the Saudi opportunity, reflect the effect of the reverse stock split and the significantly higher projected dilution due to the current low share price, resulting in a price target of USD 60.00 (previously USD 6.20 pre-split, or USD 186 post-split). We view CEL-SCI as a unique, substantially de-risked immuno-oncology play with multiple value catalysts ahead in 2025. We maintain our BUY rating.
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