JERUSALEM, July 2, 2024
/PRNewswire/ -- Scinai Immunotherapeutics Ltd. (Nasdaq:
SCNI) ("Scinai", or the "Company"), a biopharmaceutical company
focused on developing inflammation and immunology (I&I)
biological products and on providing CDMO services through its
Scinai Bioservices business unit, today published its financial
results for the quarter ended March 31,
2024, and provided a business update.
Business Update & Recent Highlights
Financing
In support of the Company's strategic pivot, on January 3, 2024, we raised $1.69 million in gross proceeds from the exercise
of certain of our outstanding warrants and the issuance of new
warrants. H.C. Wainwright & Co. acted as exclusive placement
agent in connection with the offering.
Nasdaq Compliance and Conversion of EIB Loan into
Equity
On June 7, 2024 the Company
announced that on June 5, 2024, it
received formal notification from the Listing Qualification
Department (the "Staff") of the Nasdaq Stock Market ("Nasdaq") that
the Company had regained compliance with the minimum $1.00 bid price requirement set forth in Nasdaq
Listing Rule 5550(a)(2) (the "Rule"). In the notification provided
by the Staff on June 5, 2024, the
Staff stated that the Company remains non-compliant with the equity
requirement in Listing Rule 5550(b)(1), or any of the alternative
requirements under Listing Rule 5550(b), and accordingly the
Company presented its plan to get back into compliance with the
equity requirement with the Nasdaq Hearing Panel on June 18, 2024. The Plan presented to the panel
included a debt-to-equity loan restructuring deal the Company is
working on with its lender, the European Investment Bank (the
"EIB").
On June 13, 2024 the Company
announced that it received a letter of Intent from the EIB. This
LoI outlined specific indicative terms for converting the EIB's
loan into equity. The Company expects to receive a binding term
sheet in July and have the financial contract with EIB fully
amended by the end of August.
Based on the above plan, the Company requested from the Nasdaq
Hearing Panel an extension of the deadline for regaining compliance
with the equity requirement. The Company expects to receive the
decision of the Hearing Panel in the coming weeks.
CDMO business unit
In the first six months of 2024 we received CDMO work orders
valued at approximately $500K, and we
are in advanced contract discussions with several other potential
clients. We maintain confidence in our sales guidance for 2024 of
$1.25 million in expected revenues.
As our CDMO unit is new and we are in a rapid growth stage,
acquiring new clients and building our reputation and brand
awareness of our CDMO services, we expect revenues from the
CDMO business to increase materially in the coming years. This is
also coupled with growing demand for boutique CDMO services from
early-stage biotech companies looking for fast project onset at
competitive pricing without compromising on meeting the most
stringent scientific and quality standards.
In addition, in 2024 we have been pursuing extensive targeted
marketing activities, including online advertisements, direct
outreach campaigns and participation in major pharmaceutical
conferences, such as BIO Europe Spring in Barcelona (March
2024), and the BioMed Israel conference in
Tel Aviv, Israel (May 2024), at which we marketed our CDMO services
and met potential partners for our R&D pipeline and
potential investors.
Our CDMO unit is currently focused both on executing drug
development projects for our clients and on validating our
processes and facilities to be ready for cGMP inspection by the
Israeli Ministry of Health.
In June, we held a first of its kind, hands on aseptic
processing course at our facility in Jerusalem in collaboration with key figures in
the industry including Ms. Rachel
Shimonovitz, Head of GMP inspectorate of the Israeli
Ministry of Health, and ADRES Int'l Biotech, a leading Israeli
regulatory and quality consulting services firm. The course
attracted many senior role holders from the Israeli biotech
industry who came to our facility for this two-day education and
training course.
Pipeline Development
We are aggressively advancing the NanoAb preclinical
development. At the end of April
2024, we concluded an in-vivo proof of concept animal study
in collaboration with Prof. Amos Gilhar, a world-renowned
dermatologist of the prestigious Technion Israel Institute of
Technology. The results look promising and corroborate our
aspiration for the development of a novel, local biologics
therapeutic for the treatment of patients suffering from plaque
psoriasis.
On June 4, 2024, we met for a
scientific advisory meeting with the Paul Erlich Institute (the
PEI) of Germany, the scientific
advice of which is considered acceptable guidance for IMPD filing
with the European Medicines Agency (EMA) and is also considered the
European comparable to a pre-IND meeting with the FDA in the U.S.
We expect their final minutes of the meeting in the coming
couple of weeks. Upon guidance from the PEI, we expect to commence
preparations for a pre-clinical toxicology study before commencing
a first-in-human clinical trial of our anti-IL NanoAbs for the
treatment of plaque psoriasis in 2025.
Additional NanoAbs for treatment of additional autoimmune
diseases, such as asthma, atopic dermatitis and wet AMD, have been
discovered and characterized at Max Planck and University Medical
Center Göttingen as part of their research collaboration agreement
with Scinai. Scinai holds exclusive options for exclusive licenses
at pre-agreed financial terms for each of the resulting
NanoAbs.
We are pursuing a strategic partnership for both our COVID-19
self-administered inhaled NanoAb, which demonstrated highly
promising in vivo results in animals as both a therapeutic and
prophylactic treatment, and our anti-IL-17 nanoAb for the treatment
of plaque psoriasis and other potential indications.
Q1 2024 Financial Summary
- R&D expenses for the three months ended March 31, 2024, amounted to $1,568 thousands, compared to $1,995 thousands for the three months ended
March 31, 2023. The decrease was
primarily due to a reduction in salaries and reduced use of
subcontractors.
- Marketing, general and administrative expenses for
the three months ended March 31,
2024, amounted to $484
thousands, compared to $1,191
thousands for the three months ended March 31, 2023. The decrease was primarily due to
a reduction in each of salaries, share-based compensation and
professional services.
- Financial income for the three months ended March 31, 2024, amounted to $231 thousands compared to $329 thousands for the three months ended
March 31, 2023.
- Net loss for the three months ended March 31, 2024, was $2,159
thousands compared to net loss of $3,515 thousands for the three months ended
March 31, 2023.
As of March 31, 2024, Scinai had
cash and cash equivalents and short-term deposits of $4,826 thousands compared to $4,870 thousands as of March 31, 2023.
SCINAI
IMMUNOTHERAPEUTICS LTD. (Formerly known as BiondVax Pharmaceuticals
Ltd.)
|
|
|
|
BALANCE
SHEETS
|
|
U.S. dollars in
thousands (except share and per share data)
|
|
|
|
|
|
March
31,
|
|
|
December
31,
|
|
|
|
2024
|
|
|
2023
|
|
ASSETS
|
|
Unaudited
|
|
|
Audited
|
|
|
|
|
|
|
|
|
CURRENT
ASSETS:
|
|
|
|
|
|
|
Cash and cash
equivalents
|
|
$
|
4,826
|
|
|
$
|
4,870
|
|
Restricted
cash
|
|
|
140
|
|
|
|
140
|
|
Prepaid expenses and
other receivables
|
|
|
288
|
|
|
|
437
|
|
|
|
|
|
|
|
|
|
|
Total current
assets
|
|
|
5,254
|
|
|
|
5,447
|
|
|
|
|
|
|
|
|
|
|
NON-CURRENT
ASSETS:
|
|
|
|
|
|
|
|
|
Property, plant and
equipment, net
|
|
|
10,671
|
|
|
|
10,825
|
|
Operating lease
right-of-use assets
|
|
|
1,126
|
|
|
|
1,200
|
|
|
|
|
|
|
|
|
|
|
Total non-current
assets
|
|
|
11,797
|
|
|
|
12,025
|
|
|
|
|
|
|
|
|
|
|
Total assets
|
|
$
|
17,051
|
|
|
$
|
17,472
|
|
|
|
The accompanying notes
are an integral part of the financial statements.
|
|
SCINAI
IMMUNOTHERAPEUTICS LTD. (Formerly known as BiondVax Pharmaceuticals
Ltd.)
|
|
|
|
BALANCE
SHEETS
|
|
U.S. dollars in
thousands (except share and per share data)
|
|
|
|
|
|
March
31,
|
|
|
December
31,
|
|
|
|
2024
|
|
|
2023
|
|
|
|
Unaudited
|
|
|
Audited
|
|
LIABILITIES NET OF
CAPITAL DEFICIENCY
|
|
|
|
|
|
|
|
|
|
|
|
|
|
CURRENT
LIABILITIES:
|
|
|
|
|
|
|
Trade
payables
|
|
$
|
928
|
|
|
$
|
535
|
|
Operating lease
liabilities
|
|
|
387
|
|
|
|
396
|
|
Other
payables
|
|
|
610
|
|
|
|
849
|
|
|
|
|
|
|
|
|
|
|
Total current
liabilities
|
|
|
1,925
|
|
|
|
1,780
|
|
|
|
|
|
|
|
|
|
|
NON-CURRENT
LIABILITIES:
|
|
|
|
|
|
|
|
|
Warrants
liability
|
|
|
-
|
|
|
|
96
|
|
Loan from
others
|
|
|
19,510
|
|
|
|
19,368
|
|
Non-current operating
lease liabilities
|
|
|
732
|
|
|
|
797
|
|
|
|
|
|
|
|
|
|
|
Total non-current
liabilities
|
|
|
20,242
|
|
|
|
20,261
|
|
|
|
|
|
|
|
|
|
|
CONTINGENT LIABILITIES
AND COMMITMENTS
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
SHAREHOLDERS' DEFICIT:
|
|
|
|
|
|
|
|
|
Ordinary shares of no
par value: Authorized: 20,000,000,000 shares at
March 31, 2024 and at December 31, 2023; Issued and outstanding
2,160,346,784 shares at March 31, 2024 and 1,857,169,984 shares
at
December 31, 2023
|
|
|
-
|
|
|
|
-
|
|
Additional paid-in
capital
|
|
|
121,118
|
|
|
|
119,506
|
|
Accumulated
deficit
|
|
|
(124,494)
|
|
|
|
(122,335)
|
|
Accumulated other
comprehensive loss
|
|
|
(1,740)
|
|
|
|
(1,740)
|
|
|
|
|
|
|
|
|
|
|
Total shareholders'
deficit
|
|
|
(5,116)
|
|
|
|
(4,569)
|
|
|
|
|
|
|
|
|
|
|
Total liabilities and
shareholders' deficit
|
|
$
|
17,051
|
|
|
$
|
17,472
|
|
|
The accompanying notes
are an integral part of the financial statements.
|
SCINAI
IMMUNOTHERAPEUTICS LTD. (Formerly known as BiondVax Pharmaceuticals
Ltd.)
|
|
STATEMENTS OF
OPERATIONS
|
U.S. dollars in
thousands (except share and per share data)
|
|
|
|
For the three months
ended
March 31
|
|
|
|
|
2024
|
|
|
2023
|
|
|
|
|
Unaudited
|
|
|
Unaudited
|
|
|
|
|
|
|
|
|
|
|
Research and
development expenses, net
|
|
$
|
1,568
|
|
|
$
|
1,995
|
|
|
Marketing, general, and
administrative expenses
|
|
|
484
|
|
|
|
1,191
|
|
|
Other income
|
|
|
(124)
|
|
|
|
-
|
|
|
Total operating
expenses
|
|
|
1,928
|
|
|
|
3,186
|
|
|
|
|
|
|
|
|
|
|
|
|
Total operating
loss
|
|
|
1,928
|
|
|
|
3,186
|
|
|
|
|
|
|
|
|
|
|
|
|
Total Financial
Expenses net,
|
|
|
231
|
|
|
|
329
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
|
|
$
|
2,159
|
|
|
$
|
3,515
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per share
attributable to ordinary shareholders,
basic and diluted
|
|
|
(0.001)
|
|
|
|
(0.003)
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average number
of shares used in computing
net loss per share attributable to ordinary shareholders,
basic and diluted
|
|
|
2,026,147,212
|
|
|
|
1,295,256,604
|
|
|
|
|
|
The accompanying notes
are an integral part of the financial statements.
|
|
|
SCINAI
IMMUNOTHERAPEUTICS LTD. (Formerly known as BiondVax Pharmaceuticals
Ltd.)
|
|
STATEMENTS OF
COMPREHENSIVE LOSS
|
U.S. dollars in
thousands (except share and per share data)
|
|
|
|
For the three
months
ended March 31
|
|
|
|
|
|
2024
|
|
|
2023
|
|
|
|
|
|
Unaudited
|
|
|
Unaudited
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
|
|
$
|
2,159
|
|
|
$
|
3,515
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other comprehensive
income:
|
|
|
|
|
|
|
|
|
|
|
Foreign currency
translation adjustments
|
|
|
-
|
|
|
|
(116)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total comprehensive
loss
|
|
$
|
2,159
|
|
|
$
|
3,399
|
|
|
|
|
The accompanying notes
are an integral part of the financial statements.
|
SCINAI
IMMUNOTHERAPEUTICS LTD. (Formerly known as BiondVax Pharmaceuticals
Ltd.)
|
|
STATEMENTS OF
CHANGES IN SHAREHOLDERS' EQUITY
|
U.S. dollars in
thousands (except share and per share data)
|
|
|
|
Ordinary
shares
|
|
|
Additional
paid-in
|
|
|
Accumulated
comprehensive
|
|
|
Accumulated
|
|
|
Total
shareholders'
|
|
|
|
Number
|
|
|
Amount
|
|
|
capital
|
|
|
loss
|
|
|
deficit
|
|
|
equity
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance as of December
31, 2022
|
|
|
989,290,784
|
|
|
$
|
-
|
|
|
$
|
116,082
|
|
|
$
|
(2,007)
|
|
|
$
|
(115,835)
|
|
|
$
|
(1,760)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Exercise of
warrants
|
|
|
584,015,200
|
|
|
|
-
|
|
|
|
801
|
|
|
|
-
|
|
|
|
-
|
|
|
|
801
|
|
Vested RSU's
|
|
|
8,108,400
|
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
Issuance of warrants
and shares, net of issuance costs of $86
|
|
|
160,000,000
|
|
|
|
-
|
|
|
|
1,086
|
|
|
|
-
|
|
|
|
-
|
|
|
|
1,086
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Reclassification of
warrants liability to equity
|
|
|
-
|
|
|
|
-
|
|
|
|
398
|
|
|
|
-
|
|
|
|
-
|
|
|
|
398
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Share-based
compensation
|
|
|
-
|
|
|
|
|
|
|
|
869
|
|
|
|
-
|
|
|
|
-
|
|
|
|
869
|
|
Shares issued for
services
|
|
|
115,755,600
|
|
|
|
-
|
|
|
|
270
|
|
|
|
-
|
|
|
|
-
|
|
|
|
270
|
|
Other comprehensive
income
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
267
|
|
|
|
-
|
|
|
|
267
|
|
Net loss
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
(6,500)
|
|
|
|
(6,500)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance as of December
31, 2023
|
|
|
1,857,169,984
|
|
|
$
|
-
|
|
|
$
|
119,506
|
|
|
|
$(1, 740)
|
|
|
$
|
(122,335)
|
|
|
$
|
(4,569)
|
|
Issuance of shares, net
of issuance costs of $275
|
|
|
-
|
|
|
|
-
|
|
|
|
1,421
|
|
|
|
-
|
|
|
|
-
|
|
|
|
1,421
|
|
Share-based
compensation
|
|
|
-
|
|
|
|
-
|
|
|
|
191
|
|
|
|
-
|
|
|
|
-
|
|
|
|
191
|
|
Net loss
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
(2,159)
|
|
|
|
(2,159)
|
|
Balance as of March 31,
2024
|
|
|
1,857,169,984
|
|
|
$
|
-
|
|
|
$
|
121,118
|
|
|
|
$(1, 740)
|
|
|
$
|
(124,494)
|
|
|
$
|
(5,116)
|
|
SCINAI
IMMUNOTHERAPEUTICS LTD. (Formerly known as BiondVax Pharmaceuticals
Ltd.)
|
|
STATEMENTS OF
CHANGES IN SHAREHOLDERS' EQUITY
|
U.S. dollars in
thousands (except share and per share data)
|
|
|
|
Ordinary
shares
|
|
|
Additional
paid-in
|
|
|
Accumulated
comprehensive
|
|
|
Accumulated
|
|
|
Total
shareholders'
|
|
|
|
Number
|
|
|
Amount
|
|
|
capital
|
|
|
loss
|
|
|
deficit
|
|
|
equity
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance as of December
31, 2022
|
|
|
989,290,784
|
|
|
$
|
-
|
|
|
$
|
116,082
|
|
|
|
$(2, 007)
|
|
|
$
|
(115,835)
|
|
|
$
|
(1,760)
|
|
Exercise of
warrants
|
|
|
324,000,000
|
|
|
|
-
|
|
|
|
97
|
|
|
|
-
|
|
|
|
-
|
|
|
|
97
|
|
Vested RSUs
|
|
|
332,400
|
|
|
|
|
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
Other comprehensive
income
|
|
|
-
|
|
|
|
-
|
|
|
|
|
|
|
|
116
|
|
|
|
--
|
|
|
|
116
|
|
Share-based
compensation
|
|
|
-
|
|
|
|
-
|
|
|
|
252
|
|
|
|
-
|
|
|
|
-
|
|
|
|
252
|
|
Net loss
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
(3,515)
|
|
|
|
(3,515)
|
|
Balance as of March 31,
2023
|
|
|
1,313,623,184
|
|
|
$
|
-
|
|
|
$
|
116,431
|
|
|
|
$(1, 891)
|
|
|
$
|
(119,350)
|
|
|
$
|
(4,810)
|
|
SCINAI
IMMUNOTHERAPEUTICS LTD. (Formerly known as BiondVax Pharmaceuticals
Ltd.)
|
|
|
|
STATEMENTS OF CASH
FLOWS
|
|
U.S. dollars in
thousands
|
|
|
|
|
|
For the three
months
ended March 31,
|
|
|
|
|
2024
|
|
|
2023
|
|
|
|
|
|
|
|
|
|
|
Cash flows from
operating activities:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
|
|
$
|
(2,159)
|
|
|
$
|
(3,515)
|
|
|
|
|
|
|
|
|
|
|
|
|
Adjustments to
reconcile net loss to net cash used in operating
activities:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Depreciation of
property, plant and equipment
|
|
|
156
|
|
|
|
138
|
|
|
Financial income
(expense) related to loan from others
|
|
|
225
|
|
|
|
2,354
|
|
|
Revaluation of
warrants
|
|
|
(96)
|
|
|
|
-
|
|
|
Share-based
compensation
|
|
|
191
|
|
|
|
252
|
|
|
Decrease (increase) in
other receivables
|
|
|
149
|
|
|
|
140
|
|
|
Changes in operating
lease right-of-use assets
|
|
|
75
|
|
|
|
(18)
|
|
|
Increase in trade
payables
|
|
|
309
|
|
|
|
629
|
|
|
Changes in operating
lease liabilities
|
|
|
(74)
|
|
|
|
7
|
|
|
Increase (decrease) in
other payables
|
|
|
(239)
|
|
|
|
(369)
|
|
|
|
|
|
|
|
|
|
|
|
|
Net cash used in
operating activities
|
|
|
(1,463)
|
|
|
|
(3,059)
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash flows from
investing activities:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Purchase of property,
plant and equipment
|
|
|
(2)
|
|
|
|
(6)
|
|
|
|
|
|
|
|
|
|
|
|
|
Net cash used in
investing activities
|
|
$
|
(2)
|
|
|
$
|
(6)
|
|
|
|
|
|
The accompanying notes
are an integral part of the financial statements.
|
|
|
SCINAI
IMMUNOTHERAPEUTICS LTD. (Formerly known as BiondVax Pharmaceuticals
Ltd.)
|
|
STATEMENTS OF CASH
FLOWS
|
U.S. dollars in
thousands (except share and per share data)
|
|
|
|
For the three
months
ended March 31,
|
|
|
|
|
2024
|
|
|
2023
|
|
|
|
|
|
|
|
|
|
|
Cash flows from
financing activities:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Proceed from issuance
of warrants and shares, net
|
|
$
|
1,421
|
|
|
|
-
|
|
|
|
|
|
|
|
|
|
|
|
|
Net cash provided by
financing activities
|
|
|
1,421
|
|
|
|
-
|
|
|
|
|
|
|
|
|
|
|
|
|
Effect of exchange rate
changes on cash, cash equivalents and restricted cash
|
|
|
-
|
|
|
|
(224)
|
|
|
|
|
|
|
|
|
|
|
|
|
Increase (decrease) in
cash, cash equivalents and restricted cash
|
|
|
(44)
|
|
|
|
(3,289)
|
|
|
Cash, cash equivalents
and restricted cash at beginning of year
|
|
|
5,010
|
|
|
|
14,215
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash, cash equivalents
and restricted cash at end of year
|
|
$
|
4,966
|
|
|
$
|
10,926
|
|
|
|
|
|
|
|
|
|
|
|
|
Supplementary
disclosure of cash flows activities:
|
|
|
|
|
|
|
|
|
|
(1) Cash paid during
the year for:
|
|
|
|
|
|
|
|
|
|
Interest
|
|
$
|
143
|
|
|
$
|
725
|
|
|
|
|
|
|
|
|
|
|
|
|
(2) Non-cash
transactions:
|
|
|
|
|
|
|
|
|
|
Reclassification of
warrants liability to financial income
|
|
|
96
|
|
|
|
-
|
|
|
Exercise of warrants
liability into shares
|
|
$
|
-
|
|
|
$
|
97
|
|
|
|
|
|
|
|
|
|
|
|
|
Reconciliation of cash,
cash equivalents and restricted cash:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash and cash
equivalents
|
|
$
|
4,826
|
|
|
$
|
10,799
|
|
|
Restricted
cash
|
|
|
140
|
|
|
|
127
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash, cash equivalents
and restricted cash
|
|
$
|
4,966
|
|
|
$
|
10,926
|
|
|
|
|
The accompanying notes
are an integral part of the financial statements.
|
|
About Scinai Immunotherapeutics
Scinai Immunotherapeutics Ltd. (Nasdaq: SCNI) is a
biopharmaceutical company with two complementary business units,
one focused on in-house development of inflammation and immunology
(I&I) biological therapeutic products beginning with an
innovative, de-risked pipeline of nanosized VHH antibodies
(NanoAbs) targeting diseases with large unmet medical needs, and
the other a boutique CDMO providing biological drug development,
analytical methods development, clinical cGMP manufacturing, and
pre-clinical and clinical trial design and execution services for
early stage biotech drug development projects.
Company website: www.scinai.com.
Company Contacts
Investor Relations | +972 8 930 2529 | ir@scinai.com
Business Development | +972 8 930 2529 | bd@scinai.com
Forward-Looking Statements
This press release contains forward-looking statements within
the meaning of the Private Litigation Reform Act of 1995. Words
such as "expect," "believe," "intend," "plan," "continue," "may,"
"will," "anticipate," and similar expressions are intended to
identify forward-looking statements. All statements, other than
statements of historical facts, are forward-looking statements.
Examples of such statements include, but are not limited to,
execution of a binding term sheet providing for revised terms of
the Finance Contract with EIB, the accounting impact of execution
of such revised terms and the ability of the Company to regain and
remain compliant with the continued listing standards of Nasdaq,
the potential of Scinai's NanoAb program, expected revenues of
Scinai's CDMO business and timing of pre-clinical and clinical
studies of the Company's anti-IL NanoAbs for the treatment of
plaque psoriasis and their results. These forward-looking
statements reflect management's current views with respect to
certain current and future events and are subject to various risks,
uncertainties and assumptions that could cause the results to
differ materially from those expected by the management of Scinai
Immunotherapeutics Ltd. Risks and uncertainties include, but are
not limited to, the risk that the Company will not execute a
binding term sheet with the EIB providing for revised terms
of the Finance Contract with EIB and the risk that execution of
such binding term sheet will not resolve the deficiency notice of
Nasdaq with respect to the Company's shareholders' equity; the risk
that the Company will otherwise be unable to regain compliance and
remain compliant with the continued listing requirements of Nasdaq;
lower than anticipated revenues of Scinai's CDMO business in 2024
and thereafter, failure to sign agreements with other potential
clients of the CDMO business; a delay in the commencement and
results of pre-clinical and clinical studies, the risk of delay in,
Scinai's inability to conduct, or the unsuccessful results of, its
research and development activities, including the contemplated
in-vivo studies and a clinical trial; the risk that Scinai will not
be successful in expanding its CDMO business or in-license other
NanoAbs; the risk that Scinai may not be able to secure additional
capital on attractive terms, if at all; the risk that the
therapeutic and commercial potential of NanoAbs will not be met or
that Scinai will not be successful in bringing the NanoAbs towards
commercialization; the risk of a delay in the preclinical and
clinical trials data for NanoAbs, if any; the risk that our
business strategy may not be successful; the risk that the European
Investment Bank (EIB) may accelerate the financial facility under
its finance contract with Scinai; Scinai's ability to acquire
rights to additional product opportunities; Scinai's ability to
enter into collaborations on terms acceptable to Scinai or at all;
timing of receipt of regulatory approval of Scinai's manufacturing
facility in Jerusalem, if at all
or when required; the risk that the manufacturing facility will not
be able to be used for a wide variety of applications and other
vaccine and treatment technologies; and the risk that drug
development involves a lengthy and expensive process with uncertain
outcomes. More detailed information about the risks and
uncertainties affecting the Company is contained under the heading
"Risk Factors" in the Company's Annual Report on Form 20-F filed
with the Securities and Exchange Commission ("SEC") on May 15, 2024, and the Company's subsequent
filings with the SEC. Scinai undertakes no obligation to revise or
update any forward-looking statement for any reason.
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SOURCE Scinai Immunotherapeutics Ltd.