Exhibit
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Description
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101
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Interactive data files pursuant to Rule 405 of Regulation S-T: (i) Unaudited Interim Consolidated Balance Sheets, (ii) Unaudited Interim Consolidated Statements of Operations, (iii) Unaudited Interim Consolidated Statements of Comprehensive Loss, (iv) Unaudited Consolidated Statements of Redeemable Convertible Preferred Shares and Changes in Shareholders’ Equity (v) Unaudited Consolidated Statements of Cash Flows and (vi) related notes to these consolidated financial statements.
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CHEMOMAB THERAPEUTICS LTD.
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Date: August 14, 2023
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By:
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/s/ Sigal Fattal
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Sigal Fattal
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Chief Financial Officer
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Page |
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3 |
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4 |
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5-6 |
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7 |
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8-9 |
June 30,
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December 31,
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||||||||||
Note
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2023
|
2022
|
|||||||||
Assets
|
Unaudited |
Audited |
|||||||||
Current assets
|
|||||||||||
Cash and cash equivalents
|
10,382
|
13,519
|
|||||||||
Short term bank deposits
|
16,207
|
26,374
|
|||||||||
Restricted cash |
74 |
77 |
|||||||||
Other receivables and prepaid expenses
|
1,042
|
1,766
|
|||||||||
Total current assets
|
27,705
|
41,736
|
|||||||||
Non-current assets
|
|||||||||||
Long term prepaid expenses
|
646
|
733
|
|||||||||
Property and equipment, net
|
338
|
367
|
|||||||||
Operating lease right-of-use assets
|
160
|
227
|
|||||||||
Total non-current assets
|
1,144
|
1,327
|
|||||||||
Total assets
|
28,849
|
43,063
|
|||||||||
Current liabilities
|
|||||||||||
Trade payables
|
2,347
|
1,688
|
|||||||||
Accrued expenses
|
2,503
|
3,378
|
|||||||||
Employee and related expenses
|
1,867
|
1,560
|
|||||||||
Operating lease liabilities
|
108
|
123
|
|||||||||
Total current liabilities
|
6,825
|
6,749
|
|||||||||
Non-current liabilities
|
|||||||||||
Operating lease liabilities - long term
|
33
|
91
|
|||||||||
Total non-current liabilities
|
33
|
91
|
|||||||||
Commitments and contingent liabilities
|
3 | ||||||||||
Total liabilities
|
6,858
|
6,840
|
|||||||||
Shareholders' equity (*)
|
1
|
||||||||||
Ordinary shares no par value - Authorized: 650,000,000 shares as of June 30, 2023 and December 31, 2022;
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-
|
-
|
|||||||||
Issued and outstanding: 248,058,700 Ordinary shares as of June 30, 2023 and 232,636,700 as of December 31, 2022;
|
-
|
-
|
|||||||||
Treasury share at cost (11,640,460 Ordinary shares as of June 30, 2023 and December 31, 2022) |
(1,218 |
) |
(1,218 |
) | |||||||
Additional paid in capital
|
103,751
|
101,260
|
|||||||||
Accumulated deficit
|
(80,542
|
)
|
(63,819
|
)
|
|||||||
Total shareholders’ equity
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21,991
|
36,223
|
|||||||||
Total liabilities and shareholders’ equity
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28,849
|
|
43,063 |
3
Condensed Consolidated Interim Statements of Operations (Unaudited)
Three months Ended June 30, 2023 |
Three months Ended June 30, 2022 |
Six months Ended June 30, 2023 |
Six months Ended June 30, 2022 |
||||||||||||
Operating expenses
|
|||||||||||||||
Research and development
|
5,020 |
2,914 |
11,907
|
5,659
|
|||||||||||
General and administrative
|
3,175 |
3,340 |
5,337
|
5,915
|
|||||||||||
Total operating expenses
|
8,195 |
6,254 |
17,244
|
11,574
|
|||||||||||
Financing expense (income), net |
(259 |
) |
480 |
(576
|
)
|
264
|
|||||||||
Loss before taxes
|
7,936 |
6,734 |
16,668
|
11,838
|
|||||||||||
Taxes on income (benefit) |
34 |
(544 |
) |
55
|
(544
|
) | |||||||||
Net loss for the period
|
7,970 |
6,190 |
16,723
|
11,294
|
|||||||||||
Basic and diluted loss per Ordinary Share (*)
|
0.036 |
0.027 |
0.076
|
0.050
|
|||||||||||
Weighted average number of Ordinary Shares outstanding, basic, and diluted (*)
|
221,674,130 |
228,173,276 |
221,338,951
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228,132,249
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The accompanying notes are an integral part of the condensed consolidated interim financial statements.
4
Ordinary
Shares
|
Treasury |
Additional
paid in
capital
|
Accumulated
Deficit
|
Total
Shareholders’
equity
|
||||||||||||||||||||||||
Number | USD |
Number |
USD | USD | USD | USD | ||||||||||||||||||||||
For the six-month period ended on June 30, 2023
|
||||||||||||||||||||||||||||
Balance as of January 1, 2023
|
232,636,700
|
-
|
(11,640,460 |
) |
(1,218 |
) |
101,260 |
|
(63,819
|
) |
36,223
|
|||||||||||||||||
Share-based compensation
|
-
|
-
|
- | - |
484
|
-
|
484
|
|||||||||||||||||||||
Net loss for the year
|
-
|
-
|
- | - |
-
|
(8,753
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) |
(8,753
|
) | |||||||||||||||||||
Balance as of March 31, 2023
|
232,636,700
|
-
|
(11,640,460 |
) |
(1,218 |
) |
101,744
|
(72,572
|
) |
27,954
|
||||||||||||||||||
Share-based compensation |
- | - | - | - | 639 | - | 639 | |||||||||||||||||||||
Net loss for the year |
- | - | - | - | - | (7,970 | ) |
(7,970 |
) | |||||||||||||||||||
Issuance of shares, net of issuance expenses |
15,422,000 |
- | - | - |
1,368 |
- |
1,368 |
|||||||||||||||||||||
Balance as of June 30, 2023 |
248,058,700 |
- |
(11,640,460 |
) |
(1,218 |
) |
103,751 |
(80,542 |
) | 21,991 |
The accompanying notes are an integral part of the condensed consolidated interim financial statements.
5
Ordinary
Shares
|
Additional
paid in
capital
|
Accumulated
Deficit
|
Total
Shareholders’
equity
|
|||||||||||||||||
Number
|
USD | USD | USD | USD | ||||||||||||||||
For the six-month period ended on June 30, 2022
|
||||||||||||||||||||
Balance as of January 1, 2022
|
228,090,300
|
-
|
97,639
|
(36,173
|
)
|
61,466
|
||||||||||||||
Share-based compensation
|
-
|
-
|
874
|
-
|
874
|
|||||||||||||||
Net loss for the period
|
-
|
-
|
-
|
(5,104
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)
|
(5,104
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)
|
|||||||||||||
Balance as of March 31, 2022
|
228,090,300
|
-
|
98,513
|
(41,277
|
)
|
57,236
|
||||||||||||||
Share-based compensation |
- | - | 761 | - | 761 | |||||||||||||||
Exercise of options |
542,820 |
- | 29 | - | 29 | |||||||||||||||
Net loss for the period |
- | - | - | (6,190 | ) | (6,190 |
) |
|||||||||||||
Balance as of June 30, 2022 |
228,633,120 |
- | 99,303 |
(47,467 |
) | 51,836 |
Six months
|
Six months
|
|||||||
ended
|
Ended
|
|||||||
June 30,
|
June 30,
|
|||||||
2023
|
2022
|
|||||||
Cash flows from operating activities
|
||||||||
Net loss for the period
|
(16,723
|
)
|
(11,294
|
)
|
||||
Adjustments for operating activities:
|
||||||||
Depreciation
|
32
|
27
|
||||||
Share-based compensation
|
1,123
|
1,635
|
||||||
Change in other receivables and prepaid expenses
|
811
|
(1,483
|
)
|
|||||
Change in operating lease liability
|
(6
|
)
|
(15
|
) | ||||
Change in trade payables
|
659
|
97
|
||||||
Change in accrued expenses
|
(875
|
)
|
1,157
|
|||||
Change in employees and related expenses
|
307
|
|
464
|
|||||
2,051
|
1,882
|
|||||||
Net cash used in operating activities
|
(14,672
|
)
|
(9,412
|
)
|
||||
Cash flows from investing activities
|
||||||||
Decrease in bank deposits
|
10,167
|
4,134
|
||||||
Purchase of property and equipment
|
(3
|
)
|
(25
|
)
|
||||
Net cash provided by investing activities
|
10,164
|
4,109
|
||||||
Cash flows from financing activities
|
||||||||
Issuance of Shares, net of issuance expenses |
1,368 | - | ||||||
Exercise of options |
- | 22 | ||||||
Net cash provided by financing activities
|
1,368
|
22
|
||||||
Change in cash, cash equivalents and restricted cash
|
(3,140
|
) |
(5,281
|
)
|
||||
Cash, cash equivalents and restricted cash at beginning of period
|
13,596
|
15,241
|
||||||
Cash, cash equivalents and restricted cash at end of period
|
10,456
|
9,960
|
||||||
Supplemental disclosure of non-cash investing and financing activities: |
||||||||
Receivable related to exercise of options |
- | 7 |
CHEMOMAB THERAPEUTICS LTD AND ITS SUBSIDIARIES
A.
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Chemomab Therapeutics Ltd. (the “Company") is an Israeli-based company incorporated under the laws of the State of Israel in September 2011. The Company’s registered office is located in Kiryat Atidim, Tel Aviv, Israel. The Company is a clinical-stage biotech company discovering and developing innovative therapeutics for conditions with high-unmet medical need that involve inflammation and fibrosis. The wholly owned subsidiaries of the Company are: Chemomab Ltd. ("Chemomab"), Chemomab Therapeutics Israel Ltd. and Chemomab Therapeutics Inc.
The Company currently has no products approved for sale. The Company’s operations are funded primarily by its Shareholders. The Company has incurred operating losses in each year since its inception and does not expect to generate significant revenue unless and until it obtains marketing approval for its products. Continuation of the Company’s development programs depend on its future ability to raise sources of financing. The Company believes that its existing liquidity resources as of June 30, 2023, will enable it to fund its operations through December 31, 2024 with the ability to perform cost reductions in order to extend the operations even further, if required to do so.
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B. |
On April 30, 2021, the Company entered into an At the Market Offering Agreement (the "ATM Agreement") with Cantor Fitzgerald & Co., ("Cantor"). According to the ATM Agreement, the Company may offer and sell, from time to time, its ADSs having an aggregate offering price of up to $75 million through Cantor or the ATM Agreement. On April 25, 2022, the Company filed a prospectus supplement with the SEC for the issuance and sale of up to $18,125,000 of its ADSs in connection with the reactivation of the ATM Agreement Facility and pursuant to General Instruction I.B.6 of Form S-3, which, subject to certain exceptions, limits the amount of securities the Company is able to offer and sell under such registration statement to one-third of the Company's unaffiliated public float. From April 30, 2021, through June 30, 2023, the Company issued 1,470,906 ADSs under the ATM Agreement, resulting in gross proceeds of $17,327 thousand.
|
C. |
On June 1, 2023, the board of directors (the “Board”) of the Company appointed Dr. Adi Mor as Chief Executive Officer of the Company (to replace Dr. Dale Pfost), and Sigal Fattal as the Chief Financial Officer of the Company (to replace Donald Marvin), effective as of the same date. The company has recorded in June 2023 a provision for severance payments to Dale Pfost and Donald Marvin in the amount of $1,110 thousand.
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8
CHEMOMAB THERAPEUTICS LTD AND ITS SUBSIDIARIES
(FORMERLY ANCHIANO THERAPEUTICS LTD)
NOTES TO CONDENSED CONSOLIDATED INTERIM FINANCIAL STATEMENTS
A.
|
Basis of Preparation
|
|
The condensed interim consolidated financial statements included in this quarterly report are unaudited. These financial statements have been prepared in accordance with U.S. GAAP and applicable rules and regulations of the SEC regarding interim financial reporting and reflect, in the opinion of management, all adjustments of a normal and recurring nature that are necessary for a fair statement of the Company’s financial position as of June 30, 2023, and its results of operations for the six months ended June 30, 2023, and 2022, changes in shareholders’ equity for the six months ended June 30, 2023 and 2022, and cash flows for the six months ended June 30, 2023 and 2022. The results of operations for the six months ended June 30, 2023 are not necessarily indicative of the results to be expected for the year ending December 31, 2023 or for any other future annual or interim period. These financial statements should be read in conjunction with the audited financial statements included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2022. The Company’s significant accounting policies are disclosed in the audited financial statements for the year ended December 31, 2022 included in the Company’s Annual Report on Form 10-K. Since the date of such financial statements, there have been no changes to the Company’s significant accounting policies. |
B.
|
Use of estimates
|
|
The preparation of financial statements in conformity with accounting principles generally accepted in the United States requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosures of contingent assets and liabilities at the date of the financial statements, and the reported amounts of revenues and expenses during the reporting period. Actual results could differ materially from those estimates. |
|
•
|
references to “Chemomab Therapeutics Ltd.”, “Chemomab,” the “Company,” “us,” “we” and “our” refer to Chemomab Therapeutics Ltd. an Israeli Company and its consolidated subsidiaries,
although with respect to the presentation of financial results for historical periods that preceded the Merger (as defined below), these terms refer to the financial results of Chemomab Ltd., which was the accounting acquirer in the Merger;
|
|
•
|
references to “ordinary shares,” “our shares” and similar expressions refer to the Company’s ordinary shares, no nominal (par) value;
|
|
•
|
references to “ADS” refer to the American Depositary Shares listed on the Nasdaq Capital Market (“Nasdaq”) under the symbol “CMMB,” each representing twenty (20) ordinary shares;
|
|
•
|
references to “dollars,” “U.S. dollars” and “$” are to U.S. Dollars;
|
|
•
|
references to “NIS” are to New Israeli Shekels;
|
|
•
|
references to the “SEC” are to the U.S. Securities and Exchange Commission; and
|
|
•
|
references to the “Merger” refer to the merger involving Anchiano Therapeutics Ltd. and Chemomab Ltd., whereby a wholly owned subsidiary of Anchiano Therapeutics Ltd. merged with and into
Chemomab Ltd., with Chemomab Ltd. surviving as a wholly owned subsidiary of Anchiano Therapeutics Ltd. Upon consummation of the Merger, Anchiano Therapeutics Ltd. changed its name to “Chemomab Therapeutics Ltd.” and the business conducted
by Chemomab Ltd. became primarily the business conducted by the Company.
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• |
FAST scores were improved in a higher proportion of CM-101-treated patients than in placebo patients.
|
• |
CM-101-treated patients with higher FAST scores demonstrated greater improvements in key fibro-inflammatory biomarkers than patients with lower FAST scores or placebo patients.
|
•
|
expenses incurred under agreements with contract research organizations or contract manufacturing organizations, as well as
investigative sites and consultants that conduct our clinical trials, preclinical studies and other scientific development services;
|
•
|
manufacturing scale-up expenses and the cost of acquiring and manufacturing preclinical and clinical trial materials;
|
•
|
employee-related expenses, including salaries, related benefits, travel and share-based compensation expenses for employees
engaged in research and development functions, as well as external costs, such as fees paid to outside consultants engaged in such activities;
|
•
|
license maintenance fees and milestone fees incurred in connection with various license agreements;
|
•
|
costs related to compliance with regulatory requirements; and
|
•
|
depreciation and other expenses.
|
|
Three months ended
|
|||||||||||||||
|
June 30,
|
Increase/(decrease)
|
||||||||||||||
|
2023
|
2022
|
$
|
%
|
||||||||||||
|
(in thousands)
|
|||||||||||||||
Operating expenses:
|
||||||||||||||||
Research and development
|
$
|
5,020
|
$
|
2,914
|
$
|
2,106
|
72.3
|
%
|
||||||||
General and administrative
|
3,175
|
3,340
|
(165
|
)
|
(4.9
|
)%
|
||||||||||
Operating loss
|
(8,195
|
)
|
(6,254
|
)
|
(1,941
|
)
|
31
|
%
|
||||||||
Financing expense (Income), net
|
(259
|
)
|
480
|
(739
|
)
|
154
|
%
|
|||||||||
Income Tax (benefit)
|
34
|
(544
|
)
|
578
|
(106.3
|
)%
|
||||||||||
Net loss
|
$
|
(7,970
|
)
|
$
|
(6,190
|
)
|
$
|
(1.,780
|
)
|
28.8
|
%
|
|
Six months ended
|
|||||||||||||||
|
June 30,
|
Increase/(decrease)
|
||||||||||||||
|
2023
|
2022
|
$
|
%
|
||||||||||||
|
(in thousands)
|
|||||||||||||||
Operating expenses:
|
||||||||||||||||
Research and development
|
$
|
11,907
|
$
|
5,659
|
$
|
6,248
|
110
|
%
|
||||||||
General and administrative
|
5,337
|
5,915
|
(578
|
)
|
(9.8
|
)%
|
||||||||||
Operating loss
|
(17,244
|
)
|
(11,574
|
)
|
(5,670
|
)
|
49
|
%
|
||||||||
Financing expense (Income), net
|
(576
|
)
|
264
|
(840
|
)
|
(318.2
|
)%
|
|||||||||
Income Tax (benefit)
|
55
|
(544
|
)
|
599
|
110.1
|
%
|
||||||||||
Net loss
|
$
|
(16,723
|
)
|
$
|
(11,294
|
)
|
$
|
(5,429
|
)
|
48
|
%
|
|
• |
the progress and costs of our preclinical studies, clinical trials and other research and development activities;
|
|
• |
the scope, prioritization and number of our clinical trials and other research and development programs;
|
|
• |
the amount of revenues and contributions we receive under future licensing, development and commercialization arrangements with respect to our product candidates;
|
|
• |
the costs of the development and expansion of our operational infrastructure;
|
|
• |
the costs and timing of obtaining regulatory approval for our product candidates;
|
|
• |
the costs of filing, prosecuting, enforcing and defending patent claims and other intellectual property rights;
|
|
• |
the costs and timing of securing manufacturing arrangements for clinical or commercial production;
|
|
• |
the costs of contracting with third parties to provide sales and marketing capabilities for us;
|
|
• |
the costs of acquiring or undertaking development and commercialization efforts for any future products, product candidates or platforms;
|
|
• |
the magnitude of our general and administrative expenses; and
|
|
• |
any cost that we may incur under future in- and out-licensing arrangements relating to our product candidates.
|
|
Six months ended
|
|||||||||||||||
|
June 30,
|
Increase/(decrease)
|
||||||||||||||
|
2023
|
2022
|
$
|
%
|
||||||||||||
|
(in thousands)
|
|||||||||||||||
Net cash used in operating activities
|
$
|
(14,672
|
)
|
$
|
(9,412
|
)
|
$
|
(5,260
|
)
|
55.9
|
%
|
|||||
Net cash provided by (used in) investing activities
|
10,164
|
4,109
|
6,055
|
147
|
%
|
|||||||||||
Net cash provided by financing activities
|
1,368
|
22
|
1,346
|
6,118
|
%
|
|||||||||||
Net (decrease) in cash, cash equivalents and restricted cash
|
$
|
(3,140
|
)
|
$
|
(5,281
|
)
|
$
|
2,141
|
59.5
|
%
|
◾ |
Cash Position: Cash, cash equivalents and short-term bank deposits were $26.7 million as of June 30, 2023, compared to $32.8 million on March 31, 2023.
|
◾ |
Research and Development (R&D) Expenses: R&D expenses were $5.0 million for the second quarter ended June 30, 2023, compared to $2.9 million for the same quarter in 2022. The increase was
primarily due to increased clinical activities.
|
◾ |
General and Administrative (G&A) Expenses: G&A expenses were $3.2 million for the quarter ended June 30, 2023, compared to $3.3 million for the same quarter in 2022.
|
◾ |
Net Loss: Net loss was $8.0 million, or a net loss of approximately $0.04 per basic and diluted ordinary share for the second quarter of 2023, compared to a net loss of $6.2 million, or a net loss
of approximately $0.03 per basic and diluted ordinary share for the second quarter of 2022. The weighted average number of ordinary shares outstanding, basic and diluted, was 221,674,130 (equal to approximately 11.1 million ADSs) for the
quarter ended June 30, 2023.
|
Media and Investors:
Barbara Lindheim
Consulting Vice President, Investor &
Public Relations, Strategic Communications
Phone: +1 917-355-9234
barbara.lindheim@chemomab.com
|
June 30,
|
December 31,
|
|||||||
2023
|
2022
|
|||||||
|
Unaudited
|
Audited
|
||||||
Assets
|
||||||||
Current assets
|
||||||||
Cash and cash equivalents
|
10,382
|
13,519
|
||||||
Short term bank deposits
|
16,207
|
26,374
|
||||||
Restricted cash
|
74
|
77
|
||||||
Other receivables and prepaid expenses
|
1,042
|
1,766
|
||||||
Total current assets
|
27,705
|
41,736
|
||||||
Non-current assets
|
||||||||
Long term prepaid expenses
|
646
|
733
|
||||||
Property and equipment, net
|
338
|
367
|
||||||
Operating lease right-of-use assets
|
160
|
227
|
||||||
Total non-current assets
|
1,144
|
1,327
|
||||||
Total assets
|
28,849
|
43,063
|
||||||
Current liabilities
|
||||||||
Trade payables
|
2,347
|
1,688
|
||||||
Accrued expenses
|
2,503
|
3,378
|
||||||
Employee and related expenses
|
1,867
|
1,560
|
||||||
Operating lease liabilities
|
108
|
123
|
||||||
Total current liabilities
|
6,825
|
6,749
|
||||||
Non-current liabilities
|
||||||||
Operating lease liabilities - long term
|
33
|
91
|
||||||
Total non-current liabilities
|
33
|
91
|
||||||
Commitments and contingent liabilities
|
||||||||
Total liabilities
|
6,858
|
6,840
|
||||||
Shareholders' equity (*)
|
||||||||
Ordinary shares no par value - Authorized: 650,000,000 shares as of June 30, 2023 and December 31, 2022;
|
-
|
-
|
||||||
Issued and outstanding: 248,058,700 Ordinary shares as of June 30, 2023 and 232,636,700 as of December 31, 2022;
|
-
|
-
|
||||||
Treasury share at cost (11,640,460 Ordinary shares as of June 30, 2023 and December 31, 2022)
|
(1,218
|
)
|
(1,218
|
)
|
||||
Additional paid in capital
|
103,751
|
101,260
|
||||||
Accumulated deficit
|
(80,542
|
)
|
(63,819
|
)
|
||||
Total shareholders’ equity
|
21,991
|
36,223
|
||||||
Total liabilities and shareholders’ equity
|
28,849
|
43,063
|
Three months
|
Three months
|
Six months
|
Six months
|
|||||||||||||
Ended
|
Ended
|
Ended
|
Ended
|
|||||||||||||
June 30,
|
June 30,
|
June 30,
|
June 30,
|
|||||||||||||
2023
|
2022
|
2023
|
2022
|
|||||||||||||
Operating expenses
|
||||||||||||||||
Research and development
|
5,020
|
2,914
|
11,907
|
5,659
|
||||||||||||
General and administrative
|
3,175
|
3,340
|
5,337
|
5,915
|
||||||||||||
Total operating expenses
|
8,195
|
6,254
|
17,244
|
11,574
|
||||||||||||
Financing expense (income), net
|
(259
|
)
|
480
|
(576
|
)
|
264
|
||||||||||
Loss before taxes
|
7,936
|
6,734
|
16,668
|
11,838
|
||||||||||||
Taxes on income (benefit)
|
34
|
(544
|
)
|
55
|
(544
|
)
|
||||||||||
Net loss for the period
|
7,970
|
6,190
|
16,723
|
11,294
|
Basic and diluted loss per Ordinary Share (*)
|
0.036
|
0.027
|
0.076
|
0.050
|
||||||||||||
Weighted average number of Ordinary Shares outstanding, basic, and diluted (*)
|
221,674,130
|
228,173,276
|
221,338,951
|
228,132,249
|