VIENNA, Va.--(BUSINESS WIRE)--CEL-SCI Corporation (NYSE American: CVM) today reported financial results for the quarter ended March 31, 2023, as well as key clinical and corporate developments.
Clinical and Corporate Developments include:
- In addition to pursuing approval by the US Food and Drug Administration (FDA), CEL-SCI is also pursuing marketing approval for Multikine in the treatment of head and neck cancer in Canada and the European Union.
- In April 2023, CEL-SCI had a productive pre-submission meeting with Canada’s regulator, Health Canada, to determine the best regulatory path toward market approval. Based on the existing data that was summarized and presented, Health Canada advised CEL-SCI to request advance consideration for approval under a Notice of Compliance with Conditions (NOC/c) policy which facilitates earlier access for physicians and patients to promising new drugs for patients suffering from serious, life-threatening or severely debilitating diseases.
- CEL-SCI has engaged a highly regarded regulatory consultancy with expertise in Europe to prepare the documents for a meeting with the European Medicines Agency (EMA) to determine the most efficient pathway to obtain marketing approval for Multikine in Europe. The regulations for conditional approval, similar to Canada’s NOC/c, are detailed on the EMA’s site at this link: Conditional Marketing Authorisation. Europe has almost twice the number of head and neck cancer patients than the US.
- In March 2023, Eyal Talor, Ph.D., CEL-SCI’s Chief Scientific Officer, presented a poster titled “Leukocyte Interleukin Injection (LI) immunotherapy followed by radiotherapy extends overall survival (OS) in treatment naïve locally advanced primary squamous cell carcinoma of the head & neck: the IT-MATTERS Study” at the 10th European Congress on Head & Neck Oncology (ECHNO). Key study findings for the intended Multikine patient population who received radiotherapy, as recommended by National Comprehensive Cancer Network (NCCN) guidelines, following surgery include:
- The overall survival advantage accelerated and increased over time, with the benefit of adding Multikine+CIZ to the treatment regimen as compared to Standard of Care (SOC) alone increasing from 2.8% at 3 years (36 months), to 8.3% at 4 years (48 months), to 15.6% at 5 years (60 months), with a 49.7% survival for control vs. 65.3% for the Multikine treated group at 5 years.
- The hazard ratio was 0.70 (95% CI: [0.49 - 1.00]) which represents a 43% survival extension.
- Progression free survival was 8.4% higher at 5 years for patients treated with Multikine+ CIZ+SOC as compared to patients treated with SOC control alone.
- 16.5% of these patients were early tumor responders, including complete tumor responders (confirmed by pathology at surgery), following the 3-week treatment with Multikine as compared to 0% responders of patients who were treated with SOC alone.
- Multikine patients who had an early tumor response had significantly improved survival. Their death rate was only 15.6% vs. 48.7% death rate for the control patients at 5 years.
- Even the patients who did not have an early tumor response had a better survival than did the control group patients, with a 43.8% death rate vs. 48.7% death rate for control at 5 years.
- CEL-SCI is close to reaching validation of the dedicated Multikine manufacturing facility. This process had been delayed by the US Defense Production Act which gave preference to supplies for companies working on COVID products as described on FEMA’s site: Applying the Defense Production Act. Fortunately, the COVID emergency has now officially ended and validation, an important step in the FDA approval process, is moving toward completion.
“We are pleased with the results of our discussions with Health Canada regarding approval pathways for Multikine. Our Phase 3 study spanned over 20 countries, and we hope to make Multikine available to head and neck cancer patients in need across all those countries and more,” stated CEL-SCI CEO, Geert Kersten. “A stellar team of regulatory advisors and top-tier physician consultants are working with us as we are laser-focused on regulatory approval. At the same time, by presenting our growing body of data at leading medical conferences, we are building awareness of Multikine amongst the oncologists who we hope will be integrating our immunotherapy into their practice upon its approval.”
Financial Results
CEL-SCI reported a loss per share for the quarter ending March 31, 2023 of $0.19 versus a loss of $0.23 for the quarter of March 31, 2022. CEL-SCI had $10 million in cash and cash equivalents on March 31, 2023. On May 2, 2023, CEL-SCI received $1.4 million in net proceeds from a small financing. Cash used during the six months ended March 31, 2023 included a one-time $2.3 million deposit for the Company’s manufacturing facility and various other expenses that are expected to decline as key projects are being completed.
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 study, CEL-SCI studied patients who were newly diagnosed with locally advanced primary squamous cell carcinoma of the head and neck with the investigational product Multikine first, BEFORE they received surgery and radiotherapy or surgery plus concurrent radiotherapy and chemotherapy (the current standard of care for these patients). This approach is unique. Most other cancer immunotherapies are administered 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 that this Phase 3 study is the largest Phase 3 study in the world for the treatment of locally advanced primary head and neck cancer.
Multikine is designed to help the immune system “target” the tumor at a time when the immune system is still relatively intact and thereby thought to be better able to mount an attack on the tumor. The Phase 3 study was started in early 2011 and was fully enrolled with 928 patients in September 2016. To test for an overall survival benefit, the study required CEL-SCI to wait until at least 298 (deaths) events had occurred among the two main comparator groups.
The Company has operations in Vienna, Virginia, and near/in Baltimore, Maryland.
Forward-Looking Statements
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 "intends," "believes," "anticipated," "plans" and "expects," and similar expressions, are intended to identify forward-looking statements. Such statements are subject to risks and uncertainties that could cause actual results to differ materially from those projected. Such statements include, but are not limited to, statements about the terms, expected proceeds, use of proceeds and closing of the offering. Factors that could cause or contribute to such differences include an inability to duplicate the clinical results demonstrated in clinical studies, timely development of any potential products that can be shown to be safe and effective, receiving necessary regulatory approvals, difficulties in manufacturing any of the Company's potential products, inability to raise the 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 the year ended September 30, 2022. The Company undertakes no obligation to publicly release the result of any revision to these forward-looking statements which may be made to reflect the events or circumstances after the date hereof or to reflect the occurrence of unanticipated events.
* Multikine (Leukocyte Interleukin, Injection) is the trademark that CEL-SCI has registered for this investigational therapy. This proprietary name is subject to FDA review in connection with the Company's future anticipated regulatory submission for approval. Multikine has not been licensed or approved for sale, barter or exchange by the FDA or any other regulatory agency. Similarly, its safety or efficacy has not been established for any use.
CEL-SCI CORPORATION
|
|||||||
|
2023 |
|
|
|
2022 |
|
|
Operating expenses: |
|||||||
Research and development |
$ |
11,476,034 |
|
$ |
12,606,984 |
|
|
General and administrative |
|
4,350,761 |
|
|
5,788,250 |
|
|
Total operating expenses |
|
15,826,795 |
|
|
18,395,234 |
|
|
|
|
||||||
Operating loss |
|
(15,826,795 |
) |
|
(18,395,234 |
) |
|
Gain on derivative instruments |
|
- |
|
|
366,791 |
|
|
Other non-operating losses |
|
- |
|
|
(30,793 |
) |
|
Interest expense, net |
|
(311,852 |
) |
|
(546,862 |
) |
|
Other expense |
|
(57,671 |
) |
|
|
- |
|
|
|
||||||
Net loss |
|
(16,196,318 |
) |
|
(18,606,098 |
) |
|
Modification of warrants |
|
(171,552 |
) |
|
- |
|
|
|
|
||||||
Net loss available to common shareholders |
$ |
(16,367,870 |
) |
$ |
(18,606,098 |
) |
|
Net loss per common share – basic and diluted |
$ |
(0.38 |
) |
$ |
(0.43 |
) |
|
Weighted average common shares outstanding – basic and diluted |
|
43,513,571 |
|
|
43,100,070 |
|
|
CEL-SCI CORPORATION
|
|||||||
|
2023 |
|
|
|
2022 |
|
|
Operating expenses: |
|||||||
Research and development |
$ |
6,083,488 |
|
$ |
6,523,817 |
|
|
General and administrative |
|
2,092,758 |
|
|
3,028,042 |
|
|
Total operating expenses |
|
8,176,246 |
|
|
9,551,859 |
|
|
|
|
||||||
Operating loss |
|
(8,176,246 |
) |
|
(9,551,859 |
) |
|
Gain on derivative instruments |
|
- |
|
|
2,195 |
|
|
Interest expense, net |
|
(159,063 |
) |
|
(273,828 |
) |
|
Other expense |
|
(7,500 |
) |
|
|
- |
|
|
|
||||||
Net loss |
|
(8,342,809 |
) |
|
(9,823,492 |
) |
|
|
|
||||||
Net loss available to common shareholders |
$ |
(8,342,809 |
) |
$ |
(9,823,492 |
) |
|
Net loss per common share – basic and diluted |
$ |
(0.19 |
) |
$ |
(0.23 |
) |
|
Weighted average common shares outstanding – basic and diluted |
|
43,588,381 |
|
|
43,122,671 |
|
|
