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NYSE:CVM
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On May 16, 2022, CEL-SCI Corporation (NYSE:CVM) submitted its 2Q:22 Form 10-Q with the SEC. Since our last update in mid-February it has been a light quarter while CEL-SCI has been analyzing data for its completed Phase III clinical trial for Multikine designated IT-MATTERS. The highlight for the previous three months has been the company’s announcement of abstracts accepted for the American Society of Clinical Oncology (ASCO) meeting to be held June 3-7, 2022 in Chicago, IL.
CEL-SCI recognized no revenues and incurred operating expenses totaling $9.5 million during the quarter. This resulted in a net loss available to common shareholders of ($9.8) million, or ($0.23) per share.
For the second quarter ending March 31, 2022 versus the same ended March 31, 2021:
➢ Expenses for research and development increased by 25% to $6.5 million from $5.2 million. Major components of this increase include higher stock compensation expense and greater depreciation related to leasehold improvements to the manufacturing facility and additional cost related to preparing for the commercial sale of Multikine;
➢ General and administrative (G&A) expenses decreased by 9% to $3.0 million from $3.3 million attributable to a reduction in employee stock compensation expense partially offset by an increase in other net G&A expenses;
➢ Other non-operating gains were a gain of $2,000 compared to a loss of ($2.5) million largely related to fluctuations in the fair value of derivative liabilities;
➢ Net interest expense was ($0.3) million compared with ($0.3) million;
➢ Net loss totaled ($9.8) million versus ($11.3) million or ($0.23) and ($0.28) per share, respectively.
As of March 31, 2022, cash and equivalents totaled $34.3 million. Cash burn for the quarter amounted to approximately ($3.3) million versus ($8.4) million in the prior year period, with the majority of the difference attributable to higher depreciation and amortization add back, and a decrease in the “deposit” asset and other balance sheet items as well as the absence of material amounts of capital expenditures. CEL-SCI holds no debt on its balance sheet.
ASCO Abstract
CEL-SCI announced that submitted abstracts were accepted by American Society of Clinical Oncology (ASCO) for presentation during the organization’s 2022 meeting from June 3 to 7 in Chicago, IL.
Regulatory Submission
Now that the company has completed the IT-MATTERS trial, key drivers for valuation include the FDA’s willingness to accept the data available for a Biologic License Application (BLA). Additional data and information may be required prior to acceptance. The company has reached out to the FDA and contacted representatives from both the offices of oncology products and rare disease. We will update investors on these meetings, their outcomes and impact on valuation when details are made available.