CEL-SCI Reports Fiscal 2023 Financial Results and Clinical & Corporate Developments
December 22 2023 - 8:00AM
Business Wire
CEL-SCI Corporation (NYSE American: CVM) reported
financial results for the fiscal year ended September 30, 2023, as
well as key clinical and corporate developments.
Clinical and Corporate Developments:
- CEL-SCI identified the target head and neck cancer patient
population for Multikine that will be the basis for the Company’s
regulatory filings for marketing clearance. The new data were
presented at the European Society for Medical Oncology (ESMO)
Congress. The target population, which saw its 5-year risk of death
cut in half, can be identified prior to surgery upon diagnosis with
tests that physicians routinely use in cancer screenings, a key
finding for Multikine, which is a neoadjuvant therapy. A summary of
Multikine’s results in the target population include the following:
- 73% survival for Multikine vs 45% in the control at 5
years
- 28% absolute survival benefit
- Statistically significant p = 0.0015 and hazard ratio =
0.35
- Tumor reduction rate >13% and tumor downstaging >35%
- No safety signals or toxicities vs standard of care
- Target population of an estimated 145,000 patients (global,
annual) who present with:
- No nodal involvement and no extracapsular spread
- Low PD-L1 tumor expression (different from high PD-L1 targeted
by checkpoint inhibitors)
- Physicians routinely assess these features at baseline; no
extra tests needed
- These features make it easy to write a label for Multikine,
which is essential for drug approval
- Marking a major milestone toward regulatory approval, the UK’s
National Institute for Health and Care Excellence (NICE) selected
Multikine to be evaluated as the potential new standard of care for
squamous cell carcinoma of the head and neck (SCCHN). NICE posted a
detailed report from the UK’s National Institute for Health and
Care Research (NIHR) regarding Multikine, its clinical data, and
its potential to become a better standard of care in treating newly
diagnosed head and neck cancer in the UK. This published report
informs UK doctors, patients, and other interested parties that
NICE has started the review of Multikine and is soliciting public
comment. CEL-SCI has submitted its SCCHN target population data to
the UK’s health regulator, the Medicines and Healthcare Products
Regulatory Agency, and is anticipating a Scientific Advise meeting
in H1 2024.
- CEL-SCI expects to submit the target population data to the
U.S. Food and Drug Administration (FDA) and Health Canada in Q1
2024. Health Canada advised CEL-SCI to request advance
consideration for approval under a Notice of Compliance with
Conditions policy which could lead to commercialization as early as
2024 if approved. The target population data have also been
submitted to the European Medicines Agency (EMA) with a Scientific
Advise Meeting expected H1 2024.
- Additional results from the Phase 3 clinical trial of Multikine
in advanced primary head and neck cancer were presented at the
following conferences:
- 10th European Congress on Head & Neck Oncology (ECHNO) 2023
- “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” (Link to data)
- European Society for Radiotherapy and Oncology (ESTRO) 2023
- “Histopathology population (HPP) confirms Multikine* [Leukocyte
Interleukin Injection (LI)] treatment (Tx) outcome in naïve locally
advanced primary head & neck squamous cell carcinoma SCCHN)”
(Link to data)
- American Head and Neck Cancer Society’s (AHNS) 11th Annual
International Conference on Head and Neck Cancer 2023
- “Tumor cell PD-L1 biomarker confirms Leukocyte Interleukin
Injection (LI) treatment (Tx) survival outcome advantage in naive
locally advanced primary head & neck squamous cell carcinoma
(SCCHN), the IT-MATTERS Study” (Link to data)
- European Society for Medical Oncology (ESMO) Annual Congress
2023
- “Early response to Neoadjuvant Leukocyte Interleukin Injection
(LI) immunotherapy extends overall survival (OS) in locally
advanced primary squamous cell carcinoma (SCC) of the head &
neck (HN): the IT-MATTERS Study” (Link to data)
- New PD-L1 biomarker findings from the Phase 3 study, which have
been integrated into the new target population, were presented at
AHNS. The new data demonstrated that Multikine significantly
increases overall survival in patients with low levels of tumor
cell PD-L1 expression in contrast to approved checkpoint
inhibitors, such as Keytruda and Opdivo, which most often show
longer survival in a proportion of patients with a higher level of
tumor cell PD-L1 expression, suggesting a combination therapy could
boost patient outcomes. CEL-SCI filed a patent for the use of
Multikine in tumors expressing low levels of PD-L1.
- CEL-SCI’s cGMP state-of-the-art dedicated manufacturing
facility commissioning is substantially complete, a significant
milestone toward a planned Biologics License Application (BLA) with
several regulatory agencies for approval of Multikine.
“The identification of our target patient population is a
tremendous achievement that we accomplished in conjunction with
regulators and the top key opinion leaders in head and neck cancer,
backed by our Phase 3 data from the largest study of its kind in
the world. Based on these findings, Multikine’s approval pathway
focuses on the 70% of patients not well served by the two leading
approved head and neck cancer drugs, Keytruda and Opdivo, which are
not approved as pre-surgical treatments, CEL-SCI’s intended
market,” stated CEL-SCI CEO, Geert Kersten. “We are working
diligently to move forward on the regulatory front, with several
meetings and filing upcoming next year.”
Financial Results
During the year ended September 30, 2023, research and
development expenses were $22.5 million, a decrease of
approximately $2.9 million, or 11%, from $25.4 million in the prior
fiscal year. General and administrative expenses in fiscal 2023
were $9 million, a decrease of approximately $1.7 million, or 16%,
compared to the year ended September 30, 2022. Net loss narrowed by
$4.5 million, or 12%, to approximately $32.2 million for the twelve
months ended September 30, 2023 from $36.7 million in fiscal 2022.
Almost 40% of the loss is non-cash expenditures. CEL-SCI’s audited
financial statements contained an audit opinion from its
independent registered public accounting firm that included an
explanatory paragraph related to CEL-SCI’s ability to continue as a
going concern.
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 (oral cavity and soft-palate)
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). We believe this approach is unique. Most other
cancer immunotherapies are administered only after conventional
therapies have been tried and/or failed.
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 enrolled 928 patients.
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.
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, 2023. 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
STATEMENTS OF
OPERATIONS
YEARS ENDED SEPTEMBER 30, 2023
and 2022
2023
2022
Operating expenses:
Research and development
$
22,471,496
$
25,355,346
General & administrative
9,004,578
10,707,447
Total operating expenses
31,476,074
36,062,793
Operating loss
(31,476,074
)
(36,062,793
)
Gain on derivative instruments
-
366,791
Other non-operating losses
-
(30,793
)
Interest expense, net
(675,416
)
(1,081,034
)
Other (expense) income
(42,813
)
107,148
Net loss
$
(32,194,303
)
$
(36,700,681
)
Modification of warrants
(171,552
)
(929,122
)
Net loss available to common
shareholders
$
(32,365,855
)
$
(37,629,803
)
Net loss per common share – basic and
diluted
$
(0.73
)
$
(0.87
)
Weighted average common shares outstanding
– basic and diluted
44,479,865
43,148,888
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version on businesswire.com: https://www.businesswire.com/news/home/20231222804784/en/
COMPANY CONTACT: Gavin de Windt CEL-SCI Corporation (703)
506-9460
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