JERUSALEM ,
Aug. 15,
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 June 30, 2024 and provided a business update. The
Company will hold a webinar covering its Q2 2024 financial results
and business update on August
20th at 11AM
EDT/18:00 Israel time.
Registration for the webinar can be done using the
following LINK.
Business Update & Recent Highlights
Conversion of EIB Loan into Equity and Regaining Nasdaq
Compliance
On June 7, 2024, the Company
announced that on June 5, 2024, it
had received formal notification from the Listing Qualification
Department (the "Staff") of the Nasdaq Stock Market ("Nasdaq") that
the Company remains non-compliant with the requirement in Listing
Rule 5550(b)(1) that a company have stockholders' equity of at
least $2.5 million, or any of the
alternative requirements under Nasdaq Listing Rule 5550(b) ("Equity
Requirement"). Accordingly, on June
18, 2024, the Company presented its plan to regain
compliance with the Equity Requirement with the Nasdaq Hearing
Panel. The plan presented to the panel included a debt-to-equity
loan restructuring deal between the Company and the European
Investment Bank (the "EIB").
On July 3, 2024, the Company
announced that the Hearings Panel had determined to grant the
Company's request to continue its listing on The Nasdaq Stock
Market, subject to the Company meeting certain conditions,
including filing on or before August 14,
2024 a public disclosure demonstrating compliance with the
Equity Requirement.
On August 13, 2024, the Company
announced that it had signed a Loan Restructuring Agreement, which
included an amendment and restatement to the amended Finance
Contract with the EIB. The closing of the transaction is subject to
delivery of customary closing documents and is expected to close by
August 23, 2024. In connection with
the transaction, an amount equal to approximately EUR 26.6 million (equal to approximately
$29 million), including interest accrued to date, owed by the
Company to the EIB under the amended Finance Contract between the
parties will be converted into 1,000 preferred shares, no par value
per share, of the Company (the "Preferred Shares") convertible into
ADSs. Following such conversion, the total outstanding amount owed
by the Company to the EIB will be EUR
250,000 (equal to approximately $273,000). The outstanding amount will have a
maturity date of December 31, 2031, will not be prepayable in
advance, and no interest accrues or is due and payable on such
amount. Under the terms of the agreement, EIB may not convert
its Preferred Shares into ADSs for a period of twelve (12) months
from the date of issuance of the Preferred Shares. In
addition, EIB may not convert its Preferred Shares into ADSs if at
the time of conversion the aggregate number of ADSs EIB will
receive or would have been entitled to receive within the twelve
months prior to such conversion would exceed 4.99% of the ADSs
issued and outstanding at the time of such conversion.
On August 14, 2024h the
Company received from the Nasdaq Hearing Panel an extension until
August 23, 2024 to close the
restructuring transaction with the EIB and thereby demonstrate
compliance with the Equity Requirement. Following closing of the
restructuring transaction with the EIB, the Company intends to
issue a press release submitted on Form 6-K stating that as a
result of the completed loan restructuring, the Company has
stockholders' equity above $2.5
million as of the date of the filing. .
CDMO business unit
Since Jan 2024, the Company has
received CDMO work orders valued at approximately $600K, and the Company is in advanced contract
discussions with several other potential clients. The Company
maintains confidence in its sales guidance for 2024 of $1.25 million in expected revenues. As the
Company CDMO unit is new, and the Company is focused on
rapidly growing, acquiring new clients and building its reputation
and brand awareness of its CDMO services, the Company expects
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 the Company has 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 the Company marketed its CDMO services and
met potential partners for its R&D pipeline and potential
investors.
The Company's CDMO unit is currently focused both on executing
drug development projects for its clients and on validating its
processes and facilities to be ready for cGMP inspection by the
Israeli Ministry of Health.
In June 2024, the Company held its
first of its kind, hands on aseptic processing course at its
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 the Company's facility for
this two-day education and training course.
Pipeline Development
The Company is aggressively advancing the NanoAb preclinical
development. At the end of April
2024, the Company 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.
On July 15, 2024, the Company
announced promising results as the statistical analysis of
psoriasis markers measured in the study confirmed that the effect
of Scinai's NanoAb was similar to that of the two comparator drugs,
supporting the hypothesis that intralesional injection of a nanoAb
blocking the IL-17 cytokine can positively impact the inflammatory
cytokine cascade, and lead to reduction in psoriatic lesion
severity and improvement of the skin's integrity. By delivering a
biological treatment directly into psoriatic lesions, the Company
aims to improve disease management for patients suffering from mild
to moderate plaque psoriasis by offering the high potency and
specificity advantages reserved for biologic drugs while providing
a safer and more convenient treatment option compared to existing
therapies currently offered to this patient category.
On June 4, 2024, the Company 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.
Consequently, on July 23, 2024,
the Company announced the receipt of positive regulatory feedback
from the PEI for its drug development program towards Phase 1/2a
clinical trial of its anti-IL-17A/F nanoAb (SCN-1) in Plaque
Psoriasis. The minutes of meeting clarified its preclinical
toxicology and clinical program for Plaque Psoriasis with
intralesional injections for the treatment of patients with mild to
moderate Plaque Psoriasis. The PEI requested to see data of
efficacy in blocking IL-17F, and this data became available as per
the Company's announcement on July 15,
2024 describing the positive in vivo proof of concept
results. The PEI accepted the Company's position that toxicology
studies can be conducted in pigs rather than in Non-Human Primates.
The PEI also accepted the Company's position to compare the SCN-1
to placebo directly in patients with mild to moderate plaque
psoriasis while skipping the need for testing in healthy
volunteers, resulting in a phase 1/2a clinical trial, which will
assess both safety and efficacy in the same trial. Moreover, the
PEI agreed to compare SCN-1 to placebo on the same human subject, a
strategy that could significantly reduce the number of patients
required for the clinical trial. Last, the PEI commented that the
manufacturing process looks well developed and that controls and
specifications presented are acceptable.
The Phase 1/2a study is expected to include approximately 24
plaque psoriasis patients and is expected to commence in the second
half of 2025 with readout in 2026.
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.
The Company is pursuing strategic partnerships and sublicensing
options for both its COVID-19 self-administered inhaled NanoAb,
which demonstrated highly promising in vivo results in animals as
both a therapeutic and prophylactic treatment, and its anti-IL-17
nanoAb for the treatment of plaque psoriasis and other potential
indications.
Q2 2024 Financial Summary
- R&D expenses for the six months ended
June 30, 2024 amounted to
$2,788 thousand, compared to
$3,449 thousand for the six months
ended June 30, 2023. The decrease was
primarily due to a reduction in salaries and reduced use of
subcontractors.
- Marketing, general and administrative expenses for
the six months ended June 30, 2024
amounted to $1,003 thousands,
compared to $2,332 thousands for the
six months ended June 30, 2023. The
decrease was primarily due to a reduction in salaries, share-based
compensation and professional services.
- Financial expenses for the six months ended
June 30, 2024 amounted to
$526 thousand compared to
$1,496 thousand for the six months
ended June 30, 2023.
- Net loss for the six months ended June 30, 2024 was $4,481
thousand compared to net loss of $7,277 thousand for the six months ended
June 30, 2023.
As of June 30, 2024, the
Company had cash and cash equivalents and short-term deposits of
$3,076 thousands compared to
$4,870 thousands as of June 30, 2023.
BALANCE
SHEETS
|
U.S. dollars in
thousands
|
|
|
|
|
|
|
|
|
|
|
June
30,
|
|
|
December
31,
|
|
|
|
2024
|
|
|
2023
|
|
ASSETS
|
|
|
|
|
|
|
|
|
|
|
|
|
|
CURRENT
ASSETS:
|
|
|
|
|
|
|
Cash and cash
equivalents
|
|
$
|
3,076
|
|
|
$
|
4,870
|
|
Restricted
cash
|
|
|
138
|
|
|
|
140
|
|
Trade
receivables
|
|
|
119
|
|
|
|
-
|
|
Prepaid expenses and
other receivables
|
|
|
324
|
|
|
|
437
|
|
|
|
|
|
|
|
|
|
|
Total current
assets
|
|
|
3,657
|
|
|
|
5,447
|
|
|
|
|
|
|
|
|
|
|
NON-CURRENT
ASSETS:
|
|
|
|
|
|
|
|
|
Property, plant and
equipment, net
|
|
|
10,180
|
|
|
|
10,825
|
|
Operating lease
right-of-use assets
|
|
|
1,014
|
|
|
|
1,200
|
|
|
|
|
|
|
|
|
|
|
Total non-current
assets
|
|
|
11,194
|
|
|
|
12,025
|
|
|
|
|
|
|
|
|
|
|
Total assets
|
|
$
|
14,851
|
|
|
$
|
17,472
|
|
|
|
|
|
|
|
|
|
|
The accompanying notes
are an integral part of the financial statements.
|
|
BALANCE
SHEETS
|
|
U.S. dollars in
thousands (except share data)
|
|
|
|
|
|
|
|
|
|
|
June
30,
|
|
|
December
31,
|
|
|
|
2024
|
|
|
2023
|
|
|
|
|
|
|
|
|
LIABILITIES NET OF CAPITAL DEFICIENCY
|
|
|
|
|
|
|
|
|
|
|
|
|
|
CURRENT
LIABILITIES:
|
|
|
|
|
|
|
Trade payables
|
|
$
|
658
|
|
|
$
|
535
|
|
Operating lease liabilities
|
|
|
364
|
|
|
|
396
|
|
Other payables
|
|
|
650
|
|
|
|
849
|
|
|
|
|
|
|
|
|
|
|
Total current
liabilities
|
|
|
1,672
|
|
|
|
1,780
|
|
|
|
|
|
|
|
|
|
|
NON-CURRENT
LIABILITIES:
|
|
|
|
|
|
|
|
|
Warrants liability
|
|
|
3
|
|
|
|
96
|
|
Loan from others
|
|
|
19,820
|
|
|
|
19,368
|
|
Non-current operating lease liabilities
|
|
|
640
|
|
|
|
797
|
|
|
|
|
|
|
|
|
|
|
Total non-current
liabilities
|
|
|
20,463
|
|
|
|
20,261
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
SHAREHOLDERS' DEFICIT:
|
|
|
|
|
|
|
|
|
Ordinary shares of no
par value: Authorized: 20,000,000,000 shares at June 30, 2024 and
at December 31, 2023; Issued and outstanding 3,349,431,584 shares
at June 30, 2024 and 1,857,169,984 shares at December 31,
2023
|
|
|
-
|
|
|
|
-
|
|
Additional paid-in
capital
|
|
|
121,272
|
|
|
|
119,506
|
|
Accumulated
deficit
|
|
|
(126,816)
|
|
|
|
(122,335)
|
|
Accumulated other
comprehensive loss
|
|
|
(1,740)
|
|
|
|
(1,740)
|
|
|
|
|
|
|
|
|
|
|
Total shareholders'
deficit
|
|
|
(7,284)
|
|
|
|
(4,569)
|
|
|
|
|
|
|
|
|
|
|
Total liabilities and
shareholders' deficit
|
|
$
|
14,851
|
|
|
$
|
17,472
|
|
|
|
|
|
|
|
|
|
|
The accompanying notes
are an integral part of the financial statements.
|
|
STATEMENTS OF
OPERATIONS
|
|
|
|
|
|
U.S. dollars in
thousands (except share data)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
For the six months
ended June 30
|
|
|
|
|
|
2024
|
|
|
2023
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenues
|
|
|
|
$
|
284
|
|
|
$
|
-
|
|
|
Cost of
revenues
|
|
|
|
|
448
|
|
|
|
-
|
|
|
Gross loss
|
|
|
|
|
(164)
|
|
|
|
-
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and
development expenses, net
|
|
|
|
$
|
2,788
|
|
|
$
|
3,449
|
|
|
Marketing, general,
and administrative expenses
|
|
|
|
|
1,003
|
|
|
|
2,332
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total operating
expenses
|
|
|
|
|
3,791
|
|
|
|
5,781
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total operating
loss
|
|
|
|
|
3,955
|
|
|
|
5,781
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total Financial
Expenses net,
|
|
|
|
|
526
|
|
|
|
1,496
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
|
|
|
|
$
|
4,481
|
|
|
$
|
7,277
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per share
attributable to ordinary shareholders, basic and diluted
|
|
|
|
|
(0.002)
|
|
|
|
(0.006)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average
number of shares used in computing net loss per share attributable
to ordinary shareholders, basic and diluted
|
|
|
|
|
2,288,278,248
|
|
|
|
1,322,019,241
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The accompanying notes
are an integral part of the financial statements.
|
|
|
STATEMENTS OF
COMPREHENSIVE LOSS
|
U.S. dollars in
thousands
|
|
|
|
|
|
|
|
|
|
|
|
For the six months
ended June 30
|
|
|
|
|
|
2024
|
|
|
2023
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
|
|
|
|
$
|
4,481
|
|
|
$
|
7,277
|
|
|
|
|
|
|
|
|
|
|
|
|
Other comprehensive
income:
|
|
|
|
|
|
|
|
|
|
|
Foreign currency
translation adjustments
|
|
|
|
|
-
|
|
|
|
(267)
|
|
|
|
|
|
|
|
|
|
|
|
|
Total comprehensive
loss
|
|
|
|
|
4,481
|
|
|
$
|
7,010
|
|
|
|
|
|
|
|
|
|
|
|
|
The accompanying notes
are an integral part of the financial statements.
|
STATEMENTS OF
CHANGES IN SHAREHOLDERS' EQUITY
|
|
U.S. dollars in
thousands (except share data)
|
|
|
|
|
|
Ordinary
shares
|
|
|
Additional
paid-in
|
|
|
Accumulated
comprehensive
|
|
|
Accumulated
|
|
|
Total
shareholders'
|
|
|
|
Number
|
|
|
Amount
|
|
|
capital
|
|
|
loss
|
|
|
deficit
|
|
|
equity
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance as of January
1, 2024
|
|
|
1,857,169,984
|
|
|
$
|
-
|
|
|
$
|
119,506
|
|
|
|
$(1, 740)
|
|
|
$
|
(122,335)
|
|
|
$
|
(4,569)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Issuance and exercise
of warrants, net of issuance costs of $275(see note 5)
|
|
|
1,491,240,800
|
|
|
|
-
|
|
|
|
1,433
|
|
|
|
-
|
|
|
|
-
|
|
|
|
1,433
|
|
Vested RSU's
|
|
|
1,020,800
|
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
Share-based
compensation
|
|
|
-
|
|
|
|
-
|
|
|
|
333
|
|
|
|
-
|
|
|
|
-
|
|
|
|
333
|
|
Net loss
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
(4,481)
|
|
|
|
(4,481)
|
|
Balance as of June 30,
2024
|
|
|
3,349,431,584
|
|
|
|
-
|
|
|
$
|
121,272
|
|
|
|
$(1, 740)
|
|
|
$
|
(126,816
|
(
|
|
$
|
(7,284)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Ordinary
shares
|
|
|
Additional
paid-in
|
|
|
Accumulated
comprehensive
|
|
|
Accumulated
|
|
|
Total
shareholders'
|
|
|
|
Number
|
|
|
Amount
|
|
|
capital
|
|
|
loss
|
|
|
deficit
|
|
|
equity
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance as of January
1, 2023
|
|
|
989,290,784
|
|
|
$
|
-
|
|
|
$
|
116,082
|
|
|
|
$(2,007)
|
|
|
$
|
(115,835)
|
|
|
$
|
(1,760)
|
|
Exercise of
warrants
|
|
|
464,015,200
|
|
|
|
-
|
|
|
|
801
|
|
|
|
-
|
|
|
|
-
|
|
|
|
801
|
|
Vested RSU's
|
|
|
664,800
|
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
Reclassification of
warrants liability to equity
|
|
|
-
|
|
|
|
-
|
|
|
|
398
|
|
|
|
-
|
|
|
|
-
|
|
|
|
398
|
|
Share-based
compensation
|
|
|
-
|
|
|
|
-
|
|
|
|
459
|
|
|
|
-
|
|
|
|
-
|
|
|
|
459
|
|
Other comprehensive
income
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
267
|
|
|
|
|
-
|
|
|
267
|
|
Net loss
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
(7,277)
|
|
|
|
(7,277)
|
|
Balance as of June 30,
2023
|
|
|
1,453,970,784
|
|
|
|
-
|
|
|
$
|
117,740
|
|
|
|
$(1, 740)
|
|
|
$
|
(123,112
|
(
|
|
$
|
(7,112)
|
|
STATEMENTS OF CASH
FLOWS
|
|
|
|
|
U.S. dollars in
thousands
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
For the six months
ended June 30,
|
|
|
|
|
2024
|
|
|
2023
|
|
|
|
|
|
|
|
|
|
|
Cash flows from
operating activities:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
|
|
$
|
(4,481)
|
|
|
$
|
(7,277)
|
|
|
|
|
|
|
|
|
|
|
|
|
Adjustments to
reconcile net loss to net cash used in operating
activities:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Depreciation of
property, plant and equipment
|
|
|
652
|
|
|
|
285
|
|
|
Financial expense
related to loan from others
|
|
|
451
|
|
|
|
4,321
|
|
|
Revaluation of
warrants
|
|
|
(93)
|
|
|
|
(3,333)
|
|
|
Share-based
compensation
|
|
|
333
|
|
|
|
452
|
|
|
Decrease (increase) in
receivables
|
|
|
(119)
|
|
|
|
-
|
|
|
Decrease (increase) in
other receivables
|
|
|
110
|
|
|
|
8
|
|
|
Changes in operating
lease right-of-use assets
|
|
|
189
|
|
|
|
(16)
|
|
|
Increase in trade
payables
|
|
|
125
|
|
|
|
(31)
|
|
|
Changes in operating
lease liabilities
|
|
|
(189)
|
|
|
|
3
|
|
|
Increase (decrease) in
other payables
|
|
|
(199)
|
|
|
|
(347)
|
|
|
|
|
|
|
|
|
|
|
|
|
Net cash used in
operating activities
|
|
|
(3,221)
|
|
|
|
(5,935)
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash flows from
investing activities:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Purchase of property,
plant and equipment
|
|
|
(8)
|
|
|
|
(383)
|
|
|
|
|
|
|
|
|
|
|
|
|
Net cash used in
investing activities
|
|
$
|
(8)
|
|
|
$
|
(383)
|
|
|
|
|
|
|
|
|
|
|
|
|
The accompanying notes
are an integral part of the financial statements.
|
|
|
STATEMENTS OF CASH
FLOWS
|
U.S. dollars in
thousands
|
|
|
For the six months
ended June 30,
|
|
|
|
|
2024
|
|
|
2023
|
|
|
|
|
|
|
|
|
|
|
Cash flows from
financing activities:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Proceed from exercise
of warrants, net
|
|
$
|
1,433
|
|
|
|
-
|
|
|
|
|
|
|
|
|
|
|
|
|
Net cash provided by
financing activities
|
|
|
1,433
|
|
|
|
-
|
|
|
|
|
|
|
|
|
|
|
|
|
Effect of exchange rate
changes on cash, cash equivalents and restricted cash
|
|
|
121
|
|
|
|
(265)
|
|
|
|
|
|
|
|
|
|
|
|
|
Increase (decrease) in
cash, cash equivalents and restricted cash
|
|
|
(1,917)
|
|
|
|
(6,583)
|
|
|
Cash, cash equivalents
and restricted cash at beginning of year
|
|
|
5,010
|
|
|
|
14,215
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash, cash equivalents
and restricted cash at end of year
|
|
$
|
3,214
|
|
|
$
|
7,632
|
|
|
|
|
|
|
|
|
|
|
|
|
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 equity
|
|
|
-
|
|
|
|
398
|
|
|
Exercise of warrants
liability into shares
|
|
$
|
-
|
|
|
$
|
801
|
|
|
|
|
|
|
|
|
|
|
|
|
Reconciliation of cash,
cash equivalents and restricted cash:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash and cash
equivalents
|
|
$
|
3,076
|
|
|
$
|
7,506
|
|
|
Restricted
cash
|
|
|
138
|
|
|
|
126
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash, cash equivalents
and restricted cash
|
|
$
|
3,214
|
|
|
$
|
7,632
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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.
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, the
closing of the transaction with EIB, 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; risk associated with the closing of the transaction
with EIB; 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; 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.
Photo:
https://mma.prnewswire.com/media/2482084/Scinai_Immunotherapeutics.jpg
Logo:
https://mma.prnewswire.com/media/2310190/Scinai_Immunotherapeutics_Logo.jpg
Company Contacts
Investor Relations | +972 8 930
2529 | ir@scinai.com
Business Development | +972 8 930 2529
| bd@scinai.com
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SOURCE Scinai Immunotherapeutics Ltd.