NEW
YORK, Nov. 10, 2022 /PRNewswire/ -- Oramed
Pharmaceuticals Inc. ("Oramed" or the "Company") (Nasdaq: ORMP)
(TASE: ORMP) (www.oramed.com), a clinical-stage pharmaceutical
company focused on the development of oral drug delivery platforms,
today reported its financial results for the quarter ended
September 30, 2022.
"We are pleased to share our quarterly report for the third
quarter of 2022. We had a strong quarter filled with important
milestones, including positive Phase 2 NASH data and initial
positive results from our Phase 1 oral Covid-19 vaccine trial. Over
the next few months, we look forward to sharing multiple
milestones, most notably topline data from our first Phase 3 oral
insulin trial expected in January," said Oramed Chief Executive
Officer, Nadav Kidron. "Oramed
remains in a strong financial position with approximately
$160 million in cash and investments
as of September 30, 2022, allowing us
to continue advancing all aspects of our pipeline and giving us
sufficient runway to complete our pivotal oral insulin (ORMD-0801)
Phase 3 trials and advance us towards potential FDA approval."
Financial Results for the Three Month Period Ended
September 30, 2022
- As of September 30, 2022, we had
approximately $160 million in
cash and investments, comprised of $33,196,000 of available cash,
$121,119,000 of short-term bank
deposits and $5,234,000 of
marketable securities.
- Research and development expenses for the three
month period ended September 30, 2022
decreased by 12% to $5,347,000,
compared to $6,086,000 for the three
month period ended September 30,
2021. The decrease was mainly due to lower research and
development expenses in our subsidiary Oravax Inc. ("Oravax") in
the third quarter of 2022. Stock-based compensation expenses for
the three month period ended September 30,
2022 were $771,000, compared
to $495,000 during the three month
period ended September 30, 2021. This
increase was mainly due to equity awards granted to employees in
2022, and equity awards granted by Oravax to employees and board
members of Oravax and to other service providers in September 2022.
- Sales and marketing expenses for the three month
period ended September 30, 2022
increased by 169% to $463,000,
compared to $172,000 for the three
month period ended September 30,
2021. The increase was primarily due to stock-based
compensation expenses and consulting expenses. Stock-based
compensation costs for the three month period ended September 30, 2022 were $303,000, compared to $142,000 for the three month period ended
September 30, 2021. This increase was
mainly due to equity awards granted to an employee during fiscal
years 2021 and 2022.
- General and administrative expenses for the three
month period ended September 30, 2022
increased by 60% to $3,061,000
compared to $1,909,000 for the three
month period ended September 30,
2021. The increase was mainly due to higher stock-based
compensation expenses and salary expenses. Stock-based compensation
costs for the three month period ended September 30, 2022 were $1,977,000, compared to $644,000 for the three month period ended
September 30, 2021. This increase was
mainly due to equity awards granted to directors, officers and
other employees in 2022, and equity awards granted by Oravax to
employees and board members of Oravax and to other service
providers in September 2022.
- Basic and diluted loss per share of common stock
for the three month period ended September
30, 2022 decreased by 14% to $0.18, compared to $0.21 for the three month period ended
September 30, 2021. The decrease in
loss was mainly due to a higher number of weighted average shares
of common stock in the three month period ended September 30, 2022 compared to the three month
period ended September 30, 2021.
Full financial tables are included below.
About Oramed Pharmaceuticals
Oramed Pharmaceuticals (Nasdaq/TASE: ORMP) is a platform
technology pioneer in the field of oral delivery solutions for
drugs currently delivered via injection. Established in 2006, with
offices in the United States and
Israel, Oramed has developed a
novel Protein Oral Delivery (POD™) technology. Oramed is seeking to
transform the treatment of diabetes through its proprietary lead
candidate, ORMD-0801, which is being evaluated in two pivotal Phase
3 studies and has the potential to be the first commercial oral
insulin capsule for the treatment of diabetes. In addition, Oramed
is developing an oral GLP-1 (Glucagon-like peptide-1) analog
capsule (ORMD-0901).
For more information, please visit www.oramed.com.
Forward-looking statements: This press release contains
forward-looking statements. For example, we are using
forward-looking statements when we discuss the potential
development and timing of an oral COVID-19 vaccine, what our
financial position is expected to allow us to achieve, our
expectations to share multiple milestones, including topline data
from our first Phase 3 oral insulin trial, the expected timing of
results of our clinical trials, the expected timing and achievement
of milestones and other anticipated future results. In addition,
historic results of scientific research and clinical trials do not
guarantee that the conclusions of future research or trials will
suggest identical or even similar conclusions. These
forward-looking statements are based on the current expectations of
the management of Oramed only, and are subject to a number of
factors and uncertainties that could cause actual results to differ
materially from those described in the forward-looking statements,
including the risks and uncertainties related to the progress,
timing, cost, and results of clinical trials and product
development programs; difficulties or delays in obtaining
regulatory approval or patent protection for our product
candidates; competition from other pharmaceutical or biotechnology
companies; and our ability to obtain additional funding required to
conduct our research, development and commercialization activities.
In addition, the following factors, among others, could cause
actual results to differ materially from those described in the
forward-looking statements: changes in technology and market
requirements; delays or obstacles in launching our clinical trials;
changes in legislation; inability to timely develop and introduce
new technologies, products and applications; lack of validation of
our technology as we progress further and lack of acceptance of our
methods by the scientific community; inability to retain or attract
key employees whose knowledge is essential to the development of
our products; unforeseen scientific difficulties that may develop
with our process; greater cost of final product than anticipated;
loss of market share and pressure on pricing resulting from
competition; laboratory results that do not translate to equally
good results in real settings; our patents may not be sufficient;
and finally that products may harm recipients, all of which could
cause the actual results or performance of Oramed to differ
materially from those contemplated in such forward-looking
statements. Except as otherwise required by law, Oramed undertakes
no obligation to publicly release any revisions to these
forward-looking statements to reflect events or circumstances after
the date hereof or to reflect the occurrence of unanticipated
events. For a more detailed description of the risks and
uncertainties affecting Oramed, reference is made to Oramed' s
reports filed from time to time with the Securities and Exchange
Commission.
Company Contact:
Zach
Herschfus
+1-844-9-ORAMED
zach@oramed.com
FINANCIAL TABLES
|
|
|
|
|
|
ORAMED
PHARMACEUTICALS INC.
|
|
INTERIM CONDENSED
CONSOLIDATED BALANCE SHEETS
|
|
U.S. Dollars in
thousands (except share and per share data)
|
|
(UNAUDITED)
|
|
|
|
|
|
September 30,
|
|
|
December 31,
|
|
|
|
2022
|
|
|
2021
|
|
Assets
|
|
|
|
|
|
|
CURRENT
ASSETS:
|
|
|
|
|
|
|
Cash and cash
equivalents
|
|
$
|
33,196
|
|
|
$
|
27,456
|
|
Short-term
deposits
|
|
|
121,119
|
|
|
|
111,077
|
|
Marketable
securities
|
|
|
5,234
|
|
|
|
7,747
|
|
Prepaid expenses
and other current assets
|
|
|
623
|
|
|
|
1,657
|
|
Total current
assets
|
|
|
160,172
|
|
|
|
147,937
|
|
|
|
|
|
|
|
|
|
|
LONG-TERM
ASSETS:
|
|
|
|
|
|
|
|
|
Long-term deposits
|
|
|
2
|
|
|
|
25,094
|
|
Long-term investments
|
|
|
2,700
|
|
|
|
-
|
|
Marketable securities
|
|
|
-
|
|
|
|
3,875
|
|
Amounts funded in respect of employee rights upon
retirement
|
|
|
23
|
|
|
|
26
|
|
Property and equipment, net
|
|
|
535
|
|
|
|
388
|
|
Operating lease right-of-use assets
|
|
|
1,005
|
|
|
|
500
|
|
Total long-term
assets
|
|
|
4,265
|
|
|
|
29,883
|
|
Total assets
|
|
$
|
164,437
|
|
|
$
|
177,820
|
|
|
|
|
|
|
|
|
|
|
Liabilities and
stockholders' equity
|
|
|
|
|
|
|
|
|
CURRENT
LIABILITIES:
|
|
|
|
|
|
|
|
|
Accounts payable, accrued expenses and other
liabilities
|
|
$
|
4,205
|
|
|
$
|
4,535
|
|
Deferred revenues
|
|
|
2,022
|
|
|
|
2,703
|
|
Payable to related parties
|
|
|
70
|
|
|
|
-
|
|
Operating lease liabilities
|
|
|
228
|
|
|
|
130
|
|
Total current
liabilities
|
|
|
6,525
|
|
|
|
7,368
|
|
|
|
|
|
|
|
|
|
|
LONG-TERM
LIABILITIES:
|
|
|
|
|
|
|
|
|
Long-term deferred revenues
|
|
|
4,000
|
|
|
|
3,340
|
|
Employee rights upon retirement
|
|
|
21
|
|
|
|
22
|
|
Provision for uncertain tax position
|
|
|
11
|
|
|
|
11
|
|
Operating lease liabilities
|
|
|
672
|
|
|
|
370
|
|
Other liabilities
|
|
|
61
|
|
|
|
99
|
|
Total long-term
liabilities
|
|
|
4,765
|
|
|
|
3,842
|
|
|
|
|
|
|
|
|
|
|
COMMITMENTS
(note 2)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Equity
|
|
|
|
|
|
|
|
|
EQUITY ATTRIBUTABLE
TO COMPANY'S STOCKHOLDERS:
|
|
|
|
|
|
|
|
|
Common stock, $0.012
par value (60,000,000 authorized shares; 39,113,236
and 38,158,792 shares issued and outstanding as
of September 30, 2022
and December 31, 2021, respectively)
|
|
|
470
|
|
|
|
459
|
|
Additional paid-in
capital
|
|
|
307,876
|
|
|
|
292,514
|
|
Accumulated
deficit
|
|
|
(154,538)
|
|
|
|
(126,520)
|
|
Total stockholders'
equity
|
|
|
153,808
|
|
|
|
166,453
|
|
Non-controlling
interests
|
|
|
(661)
|
|
|
|
157
|
|
Total equity
|
|
|
153,147
|
|
|
|
166,610
|
|
Total liabilities and
equity
|
|
$
|
164,437
|
|
|
$
|
177,820
|
|
|
|
ORAMED
PHARMACEUTICALS INC.
|
|
INTERIM CONDENSED
CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS
|
|
U.S. Dollars in
thousands (except share and per share data)
|
|
(UNAUDITED)
|
|
|
|
|
|
Nine months
ended
|
|
|
Three months
ended
|
|
|
|
September
30,
|
|
|
September
30,
|
|
|
September
30,
|
|
|
September
30,
|
|
|
|
2022
|
|
|
2021
|
|
|
2022
|
|
|
2021
|
|
REVENUES
|
|
$
|
2,022
|
|
|
|
2,022
|
|
|
$
|
682
|
|
|
|
682
|
|
RESEARCH AND
DEVELOPMENT EXPENSES
|
|
|
20,362
|
|
|
|
15,452
|
|
|
|
5,347
|
|
|
|
6,086
|
|
SALES AND MARKETING
EXPENSES
|
|
|
1,433
|
|
|
|
172
|
|
|
|
463
|
|
|
|
172
|
|
GENERAL AND
ADMINISTRATIVE EXPENSES
|
|
|
11,085
|
|
|
|
4,937
|
|
|
|
3,061
|
|
|
|
1,909
|
|
OPERATING
LOSS
|
|
|
30,858
|
|
|
|
18,539
|
|
|
|
8,189
|
|
|
|
7,485
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
FINANCIAL INCOME
(EXPENSE), NET
|
|
|
1,930
|
|
|
|
1,031
|
|
|
|
1,036
|
|
|
|
(51)
|
|
LOSS BEFORE TAX
EXPENSES
|
|
|
28,928
|
|
|
|
17,508
|
|
|
|
7,153
|
|
|
|
7,536
|
|
TAX
EXPENSES
|
|
|
100
|
|
|
|
-
|
|
|
|
100
|
|
|
|
-
|
|
NET LOSS FOR THE
PERIOD
|
|
$
|
29,028
|
|
|
|
17,508
|
|
|
$
|
7,253
|
|
|
|
7,536
|
|
NET LOSS
ATTRIBUTABLE TO NON-
CONTROLLING INTERESTS
|
|
|
1,010
|
|
|
|
764
|
|
|
|
193
|
|
|
|
279
|
|
NET LOSS
ATTRIBUTABLE TO STOCKHOLDERS
|
|
|
28,018
|
|
|
|
16,744
|
|
|
|
7,060
|
|
|
|
7,257
|
|
LOSS PER
SHARE
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
BASIC AND DILUTED
LOSS PER SHARE OF
COMMON STOCK
|
|
$
|
0.72
|
|
|
$
|
0.54
|
|
|
$
|
0.18
|
|
|
$
|
0.21
|
|
WEIGHTED AVERAGE
NUMBER OF SHARES
OF COMMON STOCK USED IN
COMPUTING BASIC AND DILUTED LOSS
PER SHARE OF COMMON STOCK
|
|
|
38,856,514
|
|
|
|
31,097,270
|
|
|
|
39,100,231
|
|
|
|
34,539,487
|
|
ORAMED
PHARMACEUTICALS INC.
|
|
INTERIM CONDENSED
CONSOLIDATED STATEMENTS OF CASH FLOWS
|
|
U.S. dollars in
thousands
|
|
(UNAUDITED)
|
|
|
|
|
|
Nine months
ended
|
|
|
|
September
30,
|
|
|
|
2022
|
|
|
2021
|
|
CASH FLOWS FROM
OPERATING ACTIVITIES:
|
|
|
|
|
|
|
Net loss
|
|
$
|
(29,028)
|
|
|
$
|
(17,508)
|
|
Adjustments required to
reconcile net loss to net cash used in operating
activities:
|
|
|
|
|
|
|
|
|
Depreciation
|
|
|
41
|
|
|
|
69
|
|
Non-cash expense for acquired in-process research and
development
|
|
|
-
|
|
|
|
1,040
|
|
Exchange differences and interest on deposits and held to
maturity bonds
|
|
|
(933)
|
|
|
|
429
|
|
Changes in fair value of investments
|
|
|
494
|
|
|
|
(732)
|
|
Stock-based compensation
|
|
|
8,961
|
|
|
|
2,896
|
|
Changes in operating assets and liabilities:
|
|
|
|
|
|
|
|
|
Prepaid expenses and other current assets
|
|
|
1,034
|
|
|
|
128
|
|
Accounts payable, accrued expenses and related
parties
|
|
|
(330)
|
|
|
|
1,875
|
|
Net
changes in operating lease
|
|
|
(105)
|
|
|
|
-
|
|
Deferred revenues
|
|
|
(21)
|
|
|
|
(2,022)
|
|
Liability for employee rights upon retirement
|
|
|
(1)
|
|
|
|
-
|
|
Other liabilities
|
|
|
32
|
|
|
|
(74)
|
|
Total net cash used in
operating activities
|
|
|
(19,856)
|
|
|
|
(13,899)
|
|
CASH FLOWS FROM
INVESTING ACTIVITIES:
|
|
|
|
|
|
|
|
|
Purchase of held to
maturity securities
|
|
|
-
|
|
|
|
(8,593)
|
|
Purchase of short-term
deposits
|
|
|
(111,500)
|
|
|
|
(6,000)
|
|
Investment in long-term
deposits
|
|
|
-
|
|
|
|
(25,000)
|
|
Proceeds from
short-term deposits
|
|
|
128,000
|
|
|
|
9,500
|
|
Proceeds from maturity
of held to maturity securities
|
|
|
5,336
|
|
|
|
6,065
|
|
Long-term
investments
|
|
|
(2,700)
|
|
|
|
-
|
|
Proceeds from sale of
mutual funds
|
|
|
-
|
|
|
|
3,029
|
|
Funds in respect of
employee rights upon retirement
|
|
|
3
|
|
|
|
-
|
|
Purchase of property
and equipment
|
|
|
(188)
|
|
|
|
(55)
|
|
Total net cash provided
by (used in) investing activities
|
|
|
18,951
|
|
|
|
(21,054)
|
|
CASH FLOWS FROM
FINANCING ACTIVITIES:
|
|
|
|
|
|
|
|
|
Proceeds from issuance
of common stock, net of issuance costs
|
|
|
7,345
|
|
|
|
74,743
|
|
Proceeds from exercise
of warrants and options
|
|
|
42
|
|
|
|
21,496
|
|
Transaction with
non-controlling interests
|
|
|
-
|
|
|
|
1,500
|
|
Tax withholdings
related to stock-based compensation settlements
|
|
|
(783)
|
|
|
|
-
|
|
Total net cash provided
by financing activities
|
|
|
6,604
|
|
|
|
97,739
|
|
EFFECT OF EXCHANGE
RATE CHANGES ON CASH AND CASH EQUIVALENTS
|
|
|
41
|
|
|
|
(3)
|
|
|
|
|
|
|
|
|
|
|
INCREASE IN CASH AND
CASH EQUIVALENTS
|
|
|
5,740
|
|
|
|
62,783
|
|
CASH AND CASH
EQUIVALENTS AT BEGINNING OF PERIOD
|
|
|
27,456
|
|
|
|
21,630
|
|
CASH AND CASH
EQUIVALENTS AT END OF PERIOD
|
|
$
|
33,196
|
|
|
$
|
84,413
|
|
|
|
|
|
|
|
|
|
|
(A) SUPPLEMENTARY
DISCLOSURE ON CASH FLOWS -
|
|
|
|
|
|
|
|
|
Interest
received
|
|
$
|
906
|
|
|
$
|
505
|
|
(B) SUPPLEMENTARY
DISCLOSURE ON CASH FLOWS -
|
|
|
|
|
|
|
|
|
Recognition of
operating lease right of use assets and liabilities
|
|
$
|
678
|
|
|
$
|
-
|
|
(C) ASSET
ACQUISITION TRANSACTION (see note 8) -
|
|
|
|
|
|
|
|
|
In-process research and
development
|
|
|
-
|
|
|
|
1,040
|
|
Transaction with
non-controlling interests
|
|
|
-
|
|
|
|
1,500
|
|
Additional paid in
capital
|
|
|
-
|
|
|
|
(1,045)
|
|
Non-controlling
interests
|
|
$
|
-
|
|
|
$
|
(1,495)
|
|
Logo -
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SOURCE Oramed Pharmaceuticals Inc.