CVM: Start Your Engines – FDA Green Lights Confirmatory Registration Study
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CEL-SCI Corporation (NYSE:CVM) reported its fiscal third quarter on August 15, 2024 with the submission of its Form 10-Q with the SEC and a press release on the following day. Since our previous update for the fiscal second quarter, CEL-SCI has added several new individuals to its ranks, conducted a population analysis and presented data at IDDST for IT-MATTERS and raised additional capital to support the advance of Multikine towards the confirmatory registrational trial.
Financial Review
CEL-SCI recognized no revenues for its fiscal third quarter ending June 30, 2023 and incurred operating expenses totaling $6.7 million during the three-month period. This resulted in a net loss available to common shareholders of ($7.5) million, or ($0.14) per share.
For the quarter ending June 30, 2023 versus the same prior year period:
? Expenses for research and development fell 18% to $4.7 million from $5.7 million. Lower Phase III study, employee stock compensation and miscellaneous costs contributed to the decrease and were partially offset by increased spending to prepare for the confirmatory registration study;
? General and administrative expenses decreased 20% to $2.0 million from $2.5 million on lower consulting fees and employee stock compensation partially offset by other miscellaneous expenses;
? Other non-operating items were $14,000 compared to ($8,000) in the prior year;
? Net interest expense of ($0.2) million compared with ($0.2) million was related to lease liabilities and was relatively constant;
? Modification of warrants totaled ($659,000) compared to zero as several series of warrants received an extension of expiration dates;
? Net loss totaled ($7.5) million versus ($8.4) million or ($0.14) and ($0.19) per share, respectively.
As of June 30, 2024, cash and equivalents totaled $0.4 million. Cash burn for the three-month period amounted to approximately ($4.6) million, up from 3Q:23’s ($5.9) million. Following the end of the quarter, CEL-SCI closed on a gross $10.8 million common stock offering. CEL-SCI holds no debt on its balance sheet.
CEL-SCI Milestones
? Appointment of Mario Gobbo to Board of Directors – April 2024
? Dr. Giovanni Selvaggi joins CEL-SCI as clinical advisor – June 2024
? Presentation at the International Drug Discovery Science & Technology (IDDST) Congress – June 2024
o Neoadjuvant Immunotherapy for Head and Neck Cancer: Low Tumor PD-L1 Expression - IT-MATTERS – RCT
o Presented by Dr. Eyal Talor
? CEL-SCI appoints Robert Watson as Chairperson of the Board – July 2024
