Monday, January 12, 2015 8:16:11 AM
Investment Summary
We increased our price target for CEL-SCI Corporation (NYSE MKT: CVM) to $12.50/share fair value estimate, based on our Discounted Cash Flow valuation methodology. Accordingly, CVM’s shares should trade at a 1760% premium to its current valuation. Recent developments at CEL-SCI triggering the price target increase include:
• 800% Increase in Patient Enrollment Over Prior Year
In its Phase III trial for the treatment of head and neck cancer, the largest Phase III study for this indication in the world, CVM has executed on rapid acceleration in patient enrollment. The Company reported an 8- fold increase in patient enrollment in calendar 2014 over 2013 levels. This proves that CVM, in conjunction with its two new clinical research organizations (CROs), can execute on scaling up and completing the study. It also shows the study design and CVM’s Multikine immunotherapy are well accepted by dozens of doctors and top medical facilities that have signed on for the study and are willing to advise their patients to undergo treatment with Multikine.
• 2015 is the Year CVM Will Complete Patient Enrollment
As of January 5, 2015, CVM reiterated it is on track to complete the enrollment of 880 patients in its Phase III trial. As of December 2014, CVM reported 328 patients were enrolled. Given the 800% increase in annual enrollment between 2013 and 2104, we assume CVM will comfortably complete enrollment during calendar 2015.
• Potential $50 Million Windfall by May 2015
On January 6, 2015, CVM reported a trial date has been set for May 4, 2015 in its arbitration suit against its former CRO, inVentive Clinical. CVM filed an arbitration claim seeking at least $50 million in damages against the CRO for breach of contract and fraud. The CRO may look to settle out of court, prior to the May court date. A win for CVM in this arbitration could put substantial non-dilutive funding on its balance sheet, potentially enough to complete its Phase III trial with no further fundraising. With its current $65 million market cap, a $50 million settlement is more than meaningful and should boost CVM’s valuation substantially.
• CVM to Apply for Marketing Approval In Most of the World
In December 2014 CVM announced it had added 7 more clinical sites in 6 more countries bringing it very close to the target 20 countries slated to participate in the study. By conducting the largest, global study of its kind, CVM is positioning itself to apply for marketing approval for Multikine in the U.S. and the majority of regulatory agencies around the world. The treatment of head and neck cancer is a $6 billion annual global market.
• Recently Raised Additional $7 Million
In October 2014 CVM raised $7 million. This is in addition to the $8.5 million in cash the Company reported on its balance sheet as of September 30, 2014.
Additional details in the full report:
http://acceleronequity.net/Acceleron_CVM_Update.pdf
Recent CVM News
- 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
- CEL-SCI Reports Fiscal 2023 Financial Results and Clinical & Corporate Developments • Business Wire • 12/22/2023 01:00:00 PM
- Form 10-K - Annual report [Section 13 and 15(d), not S-K Item 405] • Edgar (US Regulatory) • 12/21/2023 09:15:39 PM
- UK’S National Institute for Health and Care Excellence (NICE) Selects CEL-SCI’s Multikine as Potential New Standard of Care for Head & Neck Cancer • Business Wire • 12/04/2023 01:30:00 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 11/20/2023 10:25:18 PM
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