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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 21, 2024
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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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Chemomab Therapeutics Ltd. and its subsidiaries Interim Condensed Consolidated Financial Statements As of June 30, 2024 (Unaudited) |
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June 30,
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December 31,
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||||||||||
| Note |
2024
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2023
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|||||||||
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Assets
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|||||||||||
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Current assets
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|||||||||||
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Cash and cash equivalents
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|||||||||
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Short term bank deposits
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|||||||||
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Restricted cash
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|||||||||
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Other receivables and prepaid expenses
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|||||||||
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Total current assets
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|||||||||
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Non-current assets
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|||||||||||
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Long term prepaid expenses
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|||||||||
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Property and equipment, net
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|||||||||
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Operating lease right-of-use assets
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|||||||||
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Total non-current assets
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|||||||||
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Total assets
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|||||||||
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Current liabilities
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|||||||||||
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Trade payables
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|||||||||
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Accrued expenses
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|||||||||
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Employee and related expenses
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|||||||||
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Operating lease liabilities
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|||||||||
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Total current liabilities
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|||||||||
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Non-current liabilities
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|||||||||||
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Operating lease liabilities - long term
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|||||||||
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Total non-current liabilities
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|||||||||
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Commitments and contingent liabilities
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3
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||||||||||
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Total liabilities
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|||||||||
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Shareholders' equity (*)
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|||||||||||
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Ordinary shares
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- | - | |||||||||
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Issued and outstanding:
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|||||||||||
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Additional paid in capital
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|||||||||
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Accumulated deficit
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(
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)
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(
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)
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|||||||
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Total shareholders’ equity
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|||||||||
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Total liabilities and shareholders’ equity
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|||||||||
3
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Three months
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Three months
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Six months
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Six months
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|||||||||||||
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Ended
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Ended
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Ended
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Ended
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|||||||||||||
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June 30,
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June 30,
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June 30,
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June 30,
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|||||||||||||
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2024
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2023
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2024
|
2023
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|||||||||||||
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Operating expenses
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||||||||||||||||
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Research and development
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||||||||||||
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General and administrative
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||||||||||||
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Total operating expenses
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||||||||||||
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Financing income, net
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||||||||||||
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Loss before taxes
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||||||||||||
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Taxes on income
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||||||||||||
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Net loss for the period
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||||||||||||
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Basic and diluted loss per Ordinary Share (*)
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||||||||||||
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Weighted average number of Ordinary Shares outstanding, basic, and diluted (*)
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4
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Ordinary
Shares (*)(**)
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Additional
paid in
capital
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Accumulated
Deficit
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Total Shareholders’ equity
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|||||||||||||||||
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Number
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USD
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USD
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USD
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USD
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||||||||||||||||
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For the Six-month period ended on June 30, 2024
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Balance as of January 1, 2024
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(
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)
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||||||||||||||
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Share-based compensation
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-
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|||||||||||||||
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Issuance of shares
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|||||||||||||||
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Net loss for the period
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-
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(
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)
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(
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)
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|||||||||||||
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Balance as of March 31, 2024
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(
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)
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Share-based compensation
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-
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|||||||||||||||
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Issuance of shares
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|
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|
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|||||||||||||||
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Net loss for the period
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-
|
|
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(
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)
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(
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)
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|||||||||||||
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Balance as of June 30, 2024
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(
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)
|
|
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Ordinary
Shares (*)(**)
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Treasury
Share
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Additional
paid in
capital
|
Accumulated
Deficit
|
Total Shareholders’ equity
|
||||||||||||||||||||||||
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Number
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USD
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Number
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USD
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USD
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USD
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USD
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||||||||||||||||||||||
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For the six-month period ended on June 30, 2023
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||||||||||||||||||||||||||||
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Balance as of January 1, 2023
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(
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)
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(
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)
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(
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)
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||||||||||||||||||
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Share-based compensation
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-
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|||||||||||||||||||||
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Net loss for the year
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-
|
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(
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)
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(
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)
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|||||||||||||||||||
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Balance as of March 31, 2023
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|
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(
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)
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(
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)
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(
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)
|
|
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Share-based compensation
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-
|
|
|
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|||||||||||||||||||||
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Issuance of shares, net of issuance expenses
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|||||||||||||||||||||
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Net loss for the year
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-
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(
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)
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(
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)
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|||||||||||||||||||
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Balance as of June 30, 2023
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|
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(
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)
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(
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)
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(
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)
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|
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Six months
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Six months
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|||||||
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ended
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Ended
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|||||||
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June 30,
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June 30,
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|||||||
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2024
|
2023
|
|||||||
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Cash flows from operating activities
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||||||||
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Net loss for the period
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(
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)
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(
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)
|
||||
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Adjustments for operating activities:
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||||||||
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Depreciation
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||||||
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Share-based compensation
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Change in other receivables and prepaid expenses (short and long term)
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||||||
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Change in operating leases
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(
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)
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|||||
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Change in trade payables
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||||||
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Change in accrued expenses
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(
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)
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(
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)
|
||||
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Change in employees and related expenses
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(
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)
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|
|||||
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|||||||
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Net cash used in operating activities
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(
|
)
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(
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)
|
||||
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Cash flows from investing activities
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||||||||
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Decrease in bank deposits
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|
|
||||||
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Purchase of property and equipment
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|
(
|
)
|
|||||
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Net cash provided by investing activities
|
|
|
||||||
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Cash flows from financing activities
|
||||||||
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Issuance of Shares, net of issuance expenses
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|
|
||||||
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Net cash provided by financing activities
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|
|
||||||
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Decrease in cash, cash equivalents and restricted cash
|
(
|
)
|
(
|
)
|
||||
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Cash, cash equivalents and restricted cash at beginning of period
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||||||
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Cash, cash equivalents and restricted cash at end of period
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||||||
CHEMOMAB THERAPEUTICS LTD AND ITS SUBSIDIARIES
NOTES TO THE INTERIM CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
| A. |
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.
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| B. |
In October 2023, the Company entered into an At the Market Offering Agreement (the "Roth ATM Agreement") with Roth Capital Partners, LLC, (“Roth”). According to the Roth ATM Agreement, the Company may offer and sell, from time to time, its ADSs having an aggregate offering price of up to $
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8
CHEMOMAB THERAPEUTICS LTD AND ITS SUBSIDIARIES
NOTES TO THE INTERIM CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
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A.
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Basis of Preparation
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B.
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Use of estimates
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9
CHEMOMAB THERAPEUTICS LTD AND ITS SUBSIDIARIES
(FORMERLY ANCHIANO THERAPEUTICS LTD.)
NOTES TO THE INTERIM CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
|
|
•
|
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;
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|
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•
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references to “ordinary shares,” “our shares” and similar expressions refer to the Company’s ordinary shares, no nominal (par) value;
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•
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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;
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|
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•
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references to “dollars,” “U.S. dollars” and “$” are to U.S. Dollars;
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|
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•
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references to “NIS” are to New Israeli Shekels;
|
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•
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references to the “SEC” are to the U.S. Securities and Exchange Commission; and
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|
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•
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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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| • |
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,
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Increase/(decrease)
|
||||||||||||||
|
|
2024
|
2023
|
$ |
|
%
|
|||||||||||
|
|
(in thousands)
|
|||||||||||||||
|
Operating expenses:
|
||||||||||||||||
|
Research and development
|
$
|
2,928
|
$
|
5,020
|
$
|
(2,092
|
)
|
(42
|
)%
|
|||||||
|
General and administrative
|
840
|
3,175
|
(2,335
|
)
|
(74
|
)%
|
||||||||||
|
Operating loss
|
(3,768
|
)
|
(8,195
|
)
|
4,427
|
(54
|
)%
|
|||||||||
|
Financing Income, net
|
137
|
259
|
(122
|
)
|
(47
|
)%
|
||||||||||
|
Income Tax
|
-
|
34
|
(34
|
)
|
(100
|
)%
|
||||||||||
|
Net loss
|
$
|
(3,631
|
)
|
$
|
(7,970
|
)
|
$
|
4,339
|
(54
|
)%
|
||||||
|
|
Six months ended
|
|||||||||||||||
|
|
June 30,
|
Increase/(decrease)
|
||||||||||||||
|
|
2024
|
2023
|
$ |
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%
|
|||||||||||
|
|
(in thousands)
|
|||||||||||||||
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Operating expenses:
|
||||||||||||||||
|
Research and development
|
$
|
6,080
|
$
|
11,907
|
$
|
(5,827
|
)
|
(49
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)%
|
|||||||
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General and administrative
|
1,736
|
5,337
|
(3,601
|
)
|
(67
|
)%
|
||||||||||
|
Operating loss
|
(7,816
|
)
|
(17,244
|
)
|
9,428
|
(55
|
)%
|
|||||||||
|
Financing Income, net
|
317
|
576
|
(259
|
)
|
(45
|
)%
|
||||||||||
|
Income Tax
|
-
|
55
|
(55
|
)
|
(100
|
)%
|
||||||||||
|
Net loss
|
$
|
(7,499
|
)
|
$
|
(16,723
|
)
|
$
|
9,244
|
(55
|
)%
|
||||||
| • |
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.
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|
|
Six months ended
|
|||||||||||||||
|
|
June 30,
|
Change
|
||||||||||||||
|
|
2024
|
2023
|
$ |
|
%
|
|||||||||||
|
|
(in thousands)
|
|||||||||||||||
|
Net cash used in operating activities
|
$
|
(7,191
|
)
|
$
|
(14,672
|
)
|
$
|
7,481
|
(51
|
)%
|
||||||
|
Net cash provided by investing activities
|
2,801
|
10,164
|
(7,363
|
)
|
(72
|
)%
|
||||||||||
|
Net cash provided by financing activities
|
132
|
1,368
|
(1,236
|
)
|
(90
|
)%
|
||||||||||
|
Net decrease in cash, cash equivalents and restricted cash
|
$
|
(4,258
|
)
|
$
|
(3,140
|
)
|
$
|
(1,118
|
)
|
36
|
%
|
|||||
| ◾ |
On July 30, 2024, Chemomab announced the closing of a private placement that resulted in gross proceeds of approximately $10 million. Existing investors such as OrbiMed and new investors including HBM Partners and Sphera Biotech Master
Fund participated in the financing, which extends the company’s cash runway through early 2026.
|
| ◾ |
On July 25, 2024, Chemomab reported topline results from the CM-101 Phase 2 SPRING trial in patients with PSC. CM-101 met the primary study endpoint, demonstrating a favorable safety profile over the 15-week treatment period.
CM-101-treated patients with moderate/advanced disease showed improvements on a wide range of disease-related secondary endpoints, including assessments of changes from baseline relative to placebo at Week 15 in liver stiffness; in liver
fibrosis biomarkers, including the Enhanced Liver Fibrosis (ELF) score and PRO-C3 levels; in total bilirubin and liver function tests; in pruritis (itch) and in markers of inflammation. Dose-dependent responses were observed for multiple
disease-related biomarkers. A consistent pattern of greater improvement on the secondary endpoints was observed in the study arm receiving the higher 20 mg/kg dose of CM-101 and in the prespecified subgroup of PSC patients with
moderate/advanced disease. The open label extension portion of the Phase 2 SPRING trial is continuing, with results expected to be reported in early 2025.
|
| ◾ |
On June 18, 2024, Chemomab announced new scientific publications reinforcing the clinical potential of CM-101 in PSC. A proteomic analysis of patient samples further confirmed that the company’s novel CCL24 target is associated with
disease severity and progression in PSC.
|
| ◾ |
On June 6, 2024, Chemomab participated in multiple data presentations at EASL 2024 and a Gordon Research Conference supporting the clinical potential of CM-101 as a novel treatment for PSC. The findings support CM-101’s mode of action
in liver fibrosis and could help in characterizing its anti-fibrotic drug effects and potentially serve as a translational tool in future PSC clinical trials.
|
| ◾ |
On April 18, 2024, Chemomab announced a new peer-reviewed publication reinforcing the clinical association of its novel CCL24 target with disease severity and mortality in patients with systemic sclerosis.
|
| ◾ |
On April 10, 2024, Chemomab hosted an expert PSC webinar featuring Christopher Bowlus, MD, of UC Davis Health; Ricky Safer, founder and CEO of PSC Partners Seeking a Cure and Massimo Pinzani, MD, PhD, of the UCL Institute for Liver and
Digestive Health and UPMC ISMETT.
|
| ◾ |
Cash Position: Cash, cash equivalents and short-term bank deposits were $12.8 million as of June 30, 2024, compared to $19.9 million as of December 31, 2023. On July 30, 2024, Chemomab
successfully closed a $10 million private investment.
|
| ◾ |
Research and Development (R&D) Expenses: R&D expenses were $2.9 million for the second quarter of 2024, compared to $5.0 million for the second quarter of 2023. The decrease in R&D
expenses in the second quarter of 2024 compared to the second quarter of 2023 primarily resulted from the completion of the double-blinded portion of the company’s CM-101 Phase 2 PSC trial.
|
| ◾ |
General and Administrative (G&A) Expenses: G&A expenses were $0.8 million for the second quarter of 2024, compared to $3.2 million for the second quarter of 2023. The decrease in G&A
expenses primarily reflected reductions in headcount, consulting fees and other cost savings.
|
| ◾ |
Net Loss: Net loss was $3.6 million, or a net loss of approximately $0.01 per basic and diluted ordinary share for the second quarter of 2024, compared to $8.0 million, or a net loss of
approximately $0.04 per basic and diluted ordinary share for the second quarter of 2023. The weighted average number of ordinary shares outstanding, basic and diluted, was 286,080,133 (equal to approximately 14.3 million ADSs) for the
second quarter of 2024.
|
| ◾ |
Liquidity and Capital Resources: Chemomab believes its existing liquidity resources as of June 30, 2024, together with the additional funds of approximately $10 million raised in July 2024, will
enable the Company to fund its operations through the beginning of 2026.
|
| ◾ |
Number of issued and outstanding shares: Following completion of its July 2024 financing, the Company had 18,508,057 ADSs (representing 370,161,140 ordinary shares) issued and outstanding and
25,121,231 ADSs (representing 502,424,620 ordinary shares) outstanding on a fully diluted basis.
|
| June 30, |
December 31.
|
|||||||
| 2024 |
2023
|
|||||||
|
Assets
|
||||||||
|
Current assets
|
||||||||
|
Cash and cash equivalents
|
5,036
|
9,292
|
||||||
|
Short term bank deposits
|
7,691
|
10,492
|
||||||
|
Restricted cash
|
74
|
76
|
||||||
|
Other receivables and prepaid expenses
|
654
|
1,037
|
||||||
|
Total current assets
|
13,455
|
20,897
|
||||||
|
Non-current assets
|
||||||||
|
Long term prepaid expenses
|
472
|
559
|
||||||
|
Property and equipment, net
|
276
|
303
|
||||||
|
Operating lease right-of-use assets
|
341
|
392
|
||||||
|
Total non-current assets
|
1,089
|
1,254
|
||||||
|
Total assets
|
14,544
|
22,151
|
||||||
|
Current liabilities
|
||||||||
|
Trade payables
|
1,113
|
516
|
||||||
|
Accrued expenses
|
2,546
|
3,423
|
||||||
|
Employee and related expenses
|
540
|
823
|
||||||
|
Operating lease liabilities
|
109
|
76
|
||||||
|
Total current liabilities
|
4,308
|
4,838
|
||||||
|
Non-current liabilities
|
||||||||
|
Operating lease liabilities - long term
|
251
|
316
|
||||||
|
Total non-current liabilities
|
251
|
316
|
||||||
|
Commitments and contingent liabilities
|
||||||||
|
Total liabilities
|
4,559
|
5,154
|
||||||
|
Shareholders' equity (*)
|
||||||||
|
Ordinary shares no par value - Authorized: 4,650,000,000 shares as of June 30, 2024 and 650,000,000 shares as of December 31, 2023;
|
- |
- |
||||||
|
Issued and outstanding: 287,183,800 Ordinary shares as of June 30, 2024 and 284,094,700 as of December 31, 2023;
|
-
|
-
|
||||||
|
Additional paid in capital
|
106,162
|
105,675
|
||||||
|
Accumulated deficit
|
(96,177
|
)
|
(88,678
|
)
|
||||
|
Total shareholders’ equity
|
9,985
|
16,997
|
||||||
|
Total liabilities and shareholders’ equity
|
14,544
|
22,151
|
||||||
|
Three months
|
Three months
|
Six months
|
Six months
|
|||||||||||||
|
Ended
|
Ended
|
Ended
|
Ended
|
|||||||||||||
|
June 30,
|
June 30,
|
June 30,
|
June 30,
|
|||||||||||||
|
2024
|
2023
|
2024
|
2023
|
|||||||||||||
|
Operating expenses
|
||||||||||||||||
|
Research and development
|
2,928
|
5,020
|
6,080
|
11,907
|
||||||||||||
|
General and administrative
|
840
|
3,175
|
1,736
|
5,337
|
||||||||||||
|
Total operating expenses
|
3,768
|
8,195
|
7,816
|
17,244
|
||||||||||||
|
Financing income, net
|
137
|
259
|
317
|
576
|
||||||||||||
|
Loss before taxes
|
3,631
|
7,936
|
7,499
|
16,668
|
||||||||||||
|
Taxes on income
|
-
|
34
|
-
|
55
|
||||||||||||
|
Net loss for the period
|
3,631
|
7,970
|
7,499
|
16,723
|
||||||||||||
|
Basic and diluted loss per Ordinary Share (*)
|
0.013
|
0.036
|
0.026
|
0.076
|
||||||||||||
|
Weighted average number of Ordinary Shares outstanding, basic, and diluted (*)
|
286,080,133
|
221,674,130
|
285,111,876
|
221,338,951
|