VIENNA, Va.– (BUSINESS THREAD)–CEL-SCI Corporation (NYSE American: CVM) today reported financial results for the quarter ended June 30, 2022, as well as key clinical and corporate developments.
Clinical and corporate developments include:
The American Society of Clinical Oncology (ASCO) published two abstracts related to the Phase 3 CEL-SCI randomized controlled head and neck cancer clinical trial to be held on June 3. -7, 2022 in Chicago, Illinois. The summary titles are: Multikine is given for three weeks after a cancer diagnosis, but before surgery and other treatments. In the peer-reviewed abstract presented at ASCO, a clear survival advantage was described for patients treated with Multikine before surgery in the surgery and radiation arm of the IT-MATTERS study. The survival advantage was driven by objective data derived from patients in the intention-to-treat (ITT) population who had a significant number of early complete and partial tumor responses that occurred before surgery. In five study patients, the tumors disappeared completely (confirmed by pathology) before surgery. In the overall ITT population, 8.5% of all Multikine-treated patients had a tumor response before surgery, but no tumor response was observed before surgery in the ITT control group before surgery, a statistically highly significant finding (p-value). less than 0.00000000001). This indicates that the probability of seeing these results by chance is less than 1 in ten billion. These results confirm findings from Phase 1 and 2 studies with Multikine and provide direct evidence of Multikine’s anticancer activity. Additional results from the Phase 3 study of Multikine in advanced primary head and neck cancer have been posted to the US government’s clinical trials website www.clinicaltrials.gov. This data is expected to be released to the public in the near future. CEL-SCI’s current dedicated Good Manufacturing Practices (cGMP) facility in which Multikine is manufactured is now being validated following the completion of its commercial-scale construction in the first quarter of 2022. Construction is designed to ensure that the facility meets all requirements. GMP and European regulations of the US Food and Drug Administration (FDA).
“Advanced primary squamous cell carcinoma (cancer) of the head and neck is a horrific disease for which the FDA has not approved a new treatment in many decades. Many leading drugs have failed in studies for the treatment of advanced primary head and neck cancer. Our phase 3 study shows a median survival benefit of almost 4 years for patients who received Multikine treatment before surgery and radiation. We believe this represents a significant clinical impact for those patients for whom no treatment has yielded a significant survival benefit in decades. We look forward to further peer-reviewed publications of these data,” stated CEL-SCI CEO Geert Kersten.
CEL-SCI reported an operating loss of $27.1 million for the nine months ended June 30, 2022 compared to an operating loss of $27.7 million for the nine months ended June 30, 2021 .Net cash used for the nine months ended June 30, 2022 was $13.3. millions This represents a decrease of $0.7 million compared to the nine months ended June 30, 2021. CEL-SCI reported an operating loss of $8.7 million for the three months ended June 30, 2021. 2022 compared with an operating loss of $10.5 million in the three months ended June. 30, 2021.
About CEL-SCI Corporation
CEL-SCI believes that boosting a patient’s immune system while it is still intact should provide the greatest possible impact on survival. Therefore, in the phase 3 CEL-SCI study, patients newly diagnosed with advanced primary squamous cell carcinoma of the head and neck were treated with the investigational product Multikine* first, BEFORE receiving surgery and radiotherapy or surgery plus concurrent radiochemotherapy (the current standard). care for these patients). This approach is unique. Most other cancer immunotherapies are given only after conventional therapies have been tried and/or failed. Multikine (leukocyte interleukin, injection) received orphan drug designation from the FDA for neoadjuvant therapy in patients with squamous cell carcinoma (cancer) of the head and neck. CEL-SCI believes this phase 3 study is the world’s largest phase 3 study for the treatment of primary advanced head and neck cancer.
Multikine is designed to help the immune system “see” the tumor at a time when the immune system is still relatively intact and is therefore thought to be better able to attack the tumor. The phase 3 study was initiated in early 2011 and fully enrolled 928 patients in September 2016. To demonstrate an overall survival benefit, the study required CEL-SCI to wait until they had produced at least 298 events (deaths) between the two main comparators. groups The announced study results showed a survival benefit of nearly 4 years for patients who received a Multikine treatment regimen plus surgery and radiation. When chemotherapy was added to radiotherapy after surgery, the survival benefit was negated.
The company’s LEAPS technology is being developed for rheumatoid arthritis. The company has operations in Vienna, Virginia, and near/in Baltimore, Maryland.
This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. When used in this press release, the words “intend,” “believe,” “anticipate,” “plan” and “expect” and similar expressions are intended to identify forward-looking statements. These statements are subject to risks and uncertainties that could cause actual results to differ materially from those anticipated. These statements include, but are not limited to, statements regarding the terms, expected proceeds, use of proceeds and closing of the offering. Factors that could cause or contribute to these differences include the inability to duplicate the clinical results demonstrated in clinical studies, the timely development of any potential product that can be demonstrated to be safe and effective, receiving the necessary regulatory approvals, difficulties in manufacturing any of the company’s products. potential products, inability to raise necessary capital and the risk factors set forth from time to time in CEL-SCI’s filings with the Securities and Exchange Commission, including, but not limited to, its report on Form 10-K for for the year ended September 30, 2021. The Company undertakes no obligation to publicly disclose the result of any revision of these forward-looking statements that may be made to reflect events or circumstances subsequent to the date hereof or reflect the occurrence of unforeseen events.
* Multikine (Leukocyte Interleukin, Injection) is the trademark that CEL-SCI has registered for this investigational therapy, and this proprietary name is subject to FDA review in connection with the future regulatory filing planned for the approval of the company. Multikine has not been authorized or approved for sale, barter, or exchange by the FDA or any other regulatory agency. Likewise, its safety or effectiveness for any use has not been established.