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CEL-SCI CORPORATION Original-Research: CEL-SCI Corporation (von First Berlin Equity Research GmbH): Buy
Directive transparence : information réglementée
05/12/2023 15:46
Original-Research: CEL-SCI Corporation - von First Berlin Equity Research GmbH
Einstufung von First Berlin Equity Research GmbH zu CEL-SCI Corporation
Unternehmen: CEL-SCI Corporation
ISIN: US1508376076
Anlass der Studie: Initiation of coverage Empfehlung: Buy
seit: 05.12.2023
Kursziel: USD8.40
Kursziel auf Sicht von: 12 months
Letzte Ratingänderung: -
Analyst: Christian Orquera
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).
Abstract:
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.
First Berlin Equity Research hat die Coverage von CEL-SCI Corporation (ISIN: US1508376076) aufgenommen. Das Rating von Analyst Christian Orquera ist BUY bei einem Kursziel von USD 8,40 (€7,70).
Recent CVM News
- CEL-SCI Presents Head & Neck Cancer Data at Iddst Annual Congress in Budapest: Risk of Death Cut in Half for Patients Treated With Multikine in the Target Population • Business Wire • 06/18/2024 12:00:00 PM
- Dr. Giovanni Selvaggi, Who Has Brought Several Oncology Drugs to Market, Joins CEL-SCI as Clinical Advisor • Business Wire • 06/06/2024 11:00:00 AM
- CEL-SCI Corporation Reports Second Quarter Fiscal 2024 Financial Results • Business Wire • 05/16/2024 01:00:00 PM
- Form 10-Q - Quarterly report [Sections 13 or 15(d)] • Edgar (US Regulatory) • 05/15/2024 08:17:31 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 05/10/2024 01:04:18 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 05/09/2024 05:07:10 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 05/09/2024 01:19:04 PM
- CEL-SCI Receives FDA Go-Ahead for Its Confirmatory Study of Multikine in the Treatment of Head & Neck Cancer • Business Wire • 05/08/2024 01:00:00 PM
- CEL-SCI Appoints Mario Gobbo to Its Board of Directors • Business Wire • 04/23/2024 01:00:00 PM
- CEL-SCI’s LEAPS Vaccine Offers Promising New Paradigm to Treat Rheumatoid Arthritis: Published in Frontiers in Immunology • Business Wire • 03/19/2024 01:00:00 PM
- Form DEFA14A - Additional definitive proxy soliciting materials and Rule 14(a)(12) material • Edgar (US Regulatory) • 03/07/2024 04:33:42 PM
- Form ARS - Annual Report to Security Holders • Edgar (US Regulatory) • 03/07/2024 04:33:13 PM
- CEL-SCI Corporation Issues Letter to Shareholders • Business Wire • 03/06/2024 01:45:00 PM
- CEL-SCI Corporation Reports First Quarter Fiscal 2024 Financial Results • Business Wire • 02/15/2024 01:00:00 PM
- Form 10-Q - Quarterly report [Sections 13 or 15(d)] • Edgar (US Regulatory) • 02/14/2024 09:31:12 PM
- CEL-SCI Announces Closing of $7.75 Million Public Offering of Common Stock • Business Wire • 02/13/2024 05:00:00 PM
- CEL-SCI Announces Pricing of $7.75 Million Public Offering of Common Stock • Business Wire • 02/09/2024 01:30:00 PM
- CEL-SCI Completes Commissioning of Its Multikine Manufacturing Facility for Commercial Scale Production of Head & Neck Cancer Drug • Business Wire • 02/06/2024 02:00:00 PM
- European Medicines Agency Grants CEL-SCI a Waiver of Strict Pediatric Requirements, Clearing the Path Towards Marketing Authorization for Multikine® • Business Wire • 01/31/2024 02:00:00 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 01/02/2024 02:06:17 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 01/02/2024 02:03:28 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 01/02/2024 02:00:11 PM
- Form S-8 - Securities to be offered to employees in employee benefit plans • Edgar (US Regulatory) • 12/22/2023 09:01:06 PM
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