CEL-SCI Corporation Reports Third Quarter Fiscal 2023 Financial Results
August 11 2023 - 7:00AM
Business Wire
CEL-SCI Corporation (NYSE American: CVM) today reported
financial results for the quarter ended June 30, 2023, as well as
key clinical and corporate developments.
Clinical and Corporate Developments this quarter include:
- CEL-SCI had a productive pre-submission meeting with Canada’s
regulator, Health Canada, to determine the best regulatory path
toward market approval. Health Canada advised CEL-SCI to request
advance consideration for approval under a Notice of Compliance
with Conditions (NOCC) 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 is preparing an application for the NOCC approval
as suggested and plans to file it by early next year. If Health
Canada grants the NOCC, then it is possible that CEL-SCI could
begin commercialization in 2024.
- Europe is a priority market for CEL-SCI, as Europe has more
than twice the number of head and neck cancer cases diagnosed each
year as compared to the United States (US). CEL-SCI is seeking
conditional marketing authorization for Multikine in Europe. Based
on the published guidelines, the Company believes it meets the
requirements for conditional approval of Multikine and has plans
for meetings with regulators in the fall.
- CEL-SCI had a collaborative and positive meeting with the U.S.
Food and Drug Administration (FDA). The FDA acknowledged the great
need for improved treatments for head and neck cancer, particularly
the locally advanced oral cavity that CEL-SCI is targeting and is
open to close collaboration with CEL-SCI to help demonstrate that
Multikine could fill this need. Preliminary feedback from the FDA
included that the selection criteria developed by CEL-SCI from its
Phase 3 data could be used to determine which locally advanced oral
cavity cancer patients might benefit from Multikine treatment.
CEL-SCI is preparing additional information about its Multikine
development plan for a follow-up meeting with the FDA based on this
feedback. A confirmatory clinical trial will be conducted based on
the agreed upon selection criteria for patients that will be
treated with Multikine as assessed by methods including PET-CT/MRI
screening. CEL-SCI will collaborate closely with the FDA on the
design of a clinical protocol that will allow the Company to
generate, as expeditiously as possible, the confirmatory data they
will require for approval of Multikine in the US. Importantly, this
study is also expected to have intermediate endpoints during study
enrollment for potential accelerated approval based on interim
results.
- Potentially quite impactful PD-L1 biomarker data from CEL-SCI’s
Phase 3 study was presented at the American Head and Neck Cancer
Society’s 11th Annual International Conference on Head and Neck
Cancer titled “Tumor cell PD-L1 biomarker confirms Leukocyte
Interleukin Injection (LI) treatment (Tx) survival outcome
advantage in naïve locally advanced primary head & neck
squamous cell carcinoma (SCCHN), the IT-MATTERS Study”. The data
demonstrated that the tumors of patients who responded best to
Multikine in the Phase 3 study had low levels of the PD-L1
biomarker. Currently approved checkpoint inhibitors (Keytruda and
Opdivo) which are indicated for treatment of unresectable or
recurrent or metastatic head and neck cancer are known to work best
in patients whose tumors express high PD-L1 levels and are less
likely to work in patients whose tumors express low PD-L1. These
contrasting PD-L1 data observed in patients responsive to Multikine
vs those observed in patients treated with checkpoint inhibitors
are very significant.
The data are expected to be helpful in key ways:
- Supporting marketing approval by using PD-L1 as a marker to
select patients who are most likely to benefit from Multikine
- Positioning Multikine as a combination therapy with checkpoint
inhibitors
- Combination studies may be conducted in partnership with a
larger pharma company that has an approved PD-L1 checkpoint
inhibitor
- Should combination studies with checkpoint inhibitors be
successful not only would patients benefit substantially, but the
financial benefits to CEL-SCI could be very large
- The global PD-L1/PD-1 therapeutics market was valued at $34.8
billion in 2022
- Data presented at the European Society for Radiotherapy and
Oncology (ESTRO) 2023 Congress in May confirmed that Multikine
significantly prolonged overall survival in head and neck cancer.
The presentation titled “Histopathology population (HPP) confirms
Multikine* [Leukocyte Interleukin Injection (LI)] treatment (Tx)
outcome in naïve locally advanced primary head & neck squamous
cell carcinoma SCCHN)” provided findings from a histopathology and
tumor biomarker analysis of its Phase 3 study that confirmed
Multikine-treated subjects had improved 5-year survival, showed
improved progression free survival and improved local regional
control, and a significantly lowered death rate compared to control
subjects who received standard of care alone.
“The growing body of data on the efficacy of Multikine presented
at peer-reviewed conferences is highly encouraging as we move
forward with regulatory meetings and submissions with the world’s
most respected regulators in the world in addition to FDA. The data
has also allowed us to define very well the population of patients
who have the greatest benefit from Multikine treatment. This is a
crucial part of our approval strategy in this unmet medical need as
we are aiming for conditional/accelerated approval pathways with
multiple regulators,” stated CEL-SCI CEO, Geert Kersten. “We are
also excited about the new prospect of developing Multikine in
conjunction with a pharma partner as a combination therapy with a
checkpoint inhibitor to boost patient outcomes.
Financial Results
CEL-SCI reported a loss per share for the quarter ending June
30, 2023 of $0.19 versus a loss of $0.23 for the quarter of June
30, 2022.
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, 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 CONDENSED
STATEMENTS OF OPERATIONS NINE MONTHS ENDED JUNE 30, 2023 AND 2022
(UNAUDITED)
2023
2022
Operating expenses:
Research and development
$
17,203,823
$
18,893,857
General and administrative
6,804,729
8,220,768
Total operating expenses
24,008,552
27,114,625
Operating loss
(24,008,552
)
(27,114,625
)
Gain on derivative instruments
-
366,791
Other non-operating losses
-
(30,793
)
Interest expense, net
(493,522
)
(1,460,055
)
Other expense
(61,525
)
-
Net loss
(24,563,599
)
(27,603,969
)
Modification of warrants
(171,552
)
(294,409
)
Net loss available to common
shareholders
$
(24,735,151
)
$
(28,533,091
)
Net loss per common share – basic and
diluted
$
(0.57
)
$
(0.66
)
Weighted average common shares outstanding
– basic and diluted
43,761,395
43,124,972
CEL-SCI CORPORATION CONDENSED
STATEMENTS OF OPERATIONS THREE MONTHS ENDED JUNE 30, 2023 AND 2022
(UNAUDITED)
2023
2022
Operating expenses:
Research and development
$
5,727,789
$
6,286,873
General and administrative
2,453,968
2,432,518
Total operating expenses
8,181,757
8,719,391
Operating loss
(8,181,757
)
(8,719,391
)
Interest expense, net
(181,670
)
(913,193
)
Other expense
(3,854
)
-
Net loss
(8,367,281
)
(8,997,871
)
Modification of Warrants
-
(294,409
)
Net loss available to common
shareholders
$
(8,367,281
)
$
(9,926,993
)
Net loss per common share – basic and
diluted
$
(0.19
)
$
(0.23
)
Weighted average common shares outstanding
– basic and diluted
44,254,363
43,174,775
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Gavin de Windt CEL-SCI Corporation (703) 506-9460
Cel Sci (AMEX:CVM)
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