CVM: Fiscal Year 2023 in Review
NYSE:CVM
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Fiscal Year 2023 Update
CEL-SCI Corporation (NYSE:CVM) reported fiscal year 2023 on December 22nd after filing its Form 10-K with the SEC the previous day. 2023 has been a busy year for the company with many scientific presentations reinforcing the survival benefit of Multikine and showing better performance for patients with low risk disease and low PD-L1 expression. Efforts to advance a biologics license application (BLA) in multiple jurisdictions continue with pre-submission meetings held with Health Canada, a vote of confidence from the UK’s NICE and ongoing conversations with the FDA to identify the best route forward for approval of Multikine. The company filed with the UK’s and the EMA’s regulatory authorities in September to obtain guidance for developing a conditional approval application. In October, CEL-SCI published data showing favorable efficacy in low PD-L1 expressers and in November conducted a small capital raise.
Management has outlined the steps it will follow for Multikine registration in the various regulatory territories being pursued. CEL-SCI’s goal is to come to market under a provisional approval and then conduct further work to obtain full approval later. Submissions and requests for consultation have taken place with four of the primary regulatory agencies around the world including Health Canada, the FDA, the European Medicines Agency and the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK. In this report, we will review CEL-SCI’s fiscal year 2023 financial and operational results and summarize some of the key milestones achieved during the year.
Financial Review
CEL-SCI recognized no revenues for its 2023 fiscal year ending September 30, 2023 and incurred operating expenses totaling $31.5 million during the twelve-month period. This resulted in a net loss available to common shareholders of ($32.4) million, or ($0.73) per share.
For the year ending September 30, 2023 versus the same period ending September 30, 2022:
➢ Expenses for research and development fell 11% to $22.5 million from $25.4 million. Lower employee stock compensation and clinical trial costs were partially offset by higher preparatory commercialization costs;
➢ General and administrative expenses declined 16% to $9.0 million from $10.7 million on lower employee stock compensation expense partially offset by an increase in miscellaneous administrative expenses;
➢ Other non-operating items were ($0.2) million compared to ($0.5) million in the prior year;
➢ Net interest expense of ($0.7) million compared with ($1.1) million due to greater interest income from cash holdings and less interest expense related to finance leases;
➢ Net loss totaled ($32.4) million versus ($37.6) million or ($0.73) and ($0.87) per share, respectively.
As of September 30, 2023, cash and equivalents totaled $4.1 million. Cash burn for the twelve-month period amounted to approximately ($23.2) million, greater in magnitude compared with last year’s ($18.9) million. After the end of the quarter, CEL-SCI sold 2.5 million shares of common stock to raise net proceeds of $4.5 million. CEL-SCI holds no debt on its balance sheet.
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