UNITED STATES
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99.1
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Unaudited Condensed Financial Statements as of June 30, 2025
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99.2
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Operating and Financial Review as of June 30, 2025 and for the six months then ended
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99.3
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Press Release dated October 1, 2025
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Exhibit
No.
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Description
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Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
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Date: October 1, 2025
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PAINREFORM LTD.
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By:
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/s/ Ehud Geller
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Ehud Geller
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Executive Chairman of the Board and Interim Chief Executive Officer
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Page |
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F - 2 |
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F - 3 |
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F - 4 |
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F - 5 |
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F - 6 - F - 15 |
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PAINREFORM LTD.
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CONDENSED BALANCE SHEETS (Unaudited)
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U.S. dollars in thousands
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|
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As of
June 30, |
As of
December 31, |
|||||||||
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Note
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2025
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2024
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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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3,479
|
$
|
4,261
|
|||||||
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Restricted cash
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15
|
10
|
|||||||||
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Prepaid expenses and other current assets
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4
|
415
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157
|
||||||||
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Total current assets
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3,909
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4,428
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|||||||||
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Non-current assets
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|||||||||||
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Intangible assets, net
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8
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7,119
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-
|
||||||||
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Bridge loan
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50
|
-
|
|||||||||
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Operating lease right of use asset
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6
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58
|
62
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||||||||
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Property and equipment, net
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26
|
35
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|||||||||
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Total long-term assets
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7,253
|
97
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|||||||||
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Total assets
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$
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11,162
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$
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4,525
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Liabilities and shareholders’ equity
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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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164
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$
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296
|
|||||||
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Employees and related liabilities
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405
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197
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|||||||||
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Operating lease liability
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6
|
56
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45
|
||||||||
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Accrued expenses
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5
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1,831
|
1,904
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||||||||
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Total current liabilities
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2,456
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2,442
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|||||||||||
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Non-current liabilities:
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|||||||||||
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|||||||||||
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Provision for uncertain tax positions
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263
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259
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|||||||||
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Total non-current liabilities
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263
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259
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|||||||||||
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Total liabilities
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2,719
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2,701
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Commitments (Note 10)
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Shareholders’ equity:
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Ordinary shares, No par value; Authorized: 10,000,000 and 2,500,000 shares as of June 30, 2025, and December 31, 2024, respectively
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|||||||||||
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Issued and outstanding: 2,013,141 and 1,471,412 shares as of June 30, 2025, and December 31, 2024, respectively.
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Additional paid-in capital
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7a
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67,210
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58,275
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Accumulated deficit
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(58,767
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)
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(56,451
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)
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|||||||||||
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Total shareholders’ equity
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8,443
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1,824
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Total liabilities and shareholders’ equity
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$
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11,162
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$
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4,525
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PAINREFORM LTD.
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CONDENSED STATEMENTS OF COMPREHENSIVE LOSS (Unaudited)
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U.S. dollars in thousands (except share and per share data)
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For the Six Months Ended
June, |
||||||||||
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Note
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2025
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2024
|
||||||||
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|||||||||||
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Operating expenses:
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|||||||||||
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Amortization of intangible assets
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$
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(173
|
)
|
$
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-
|
||||||
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Research and development expenses
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(278
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)
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(11,407
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)
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|||||||
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General and administrative expenses
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(1,917
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)
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(1,503
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)
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|||||||||||
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Operating loss
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(2,368
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)
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(12,910
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)
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|||||||||||
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Financial income, net
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9
|
52
|
92
|
||||||||
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Net loss and comprehensive loss
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$
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(2,316
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)
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$
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(12,818
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)
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|||||
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|||||||||||
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Basic and diluted net loss per share
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7
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$
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(1.09
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)
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$
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(63.15
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)
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|||||||||||
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Weighted average number of Ordinary shares used in computing basic and diluted net loss per share
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2,123,538
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202,991
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PAINREFORM LTD.
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CONDESNED STATEMENT OF CHANGES IN SHAREHOLDERS’ (DEFICIT) EQUITY (Unaudited)
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U.S. dollars in thousands
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Ordinary shares
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Additional
paid-in |
Accumulated
|
Total
shareholders’ |
||||||||||||
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Number
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Capital
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Deficit
|
equity
|
||||||||||||
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||||||||||||||||
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Balance as of January 1, 2024
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165,489
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$
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49,102
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$
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(41,863
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)
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$
|
7,239
|
||||||||
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Share-based compensation to employees and directors
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-
|
198
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-
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198
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Share issuance |
12,412 |
- | - | - | ||||||||||||
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Issuance of common stock, warrants and prefunded warrants upon private placement, net of underwriting commissions and other offering costs
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18,646
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3,340
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-
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3,340
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Exercise of prefunded warrants
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41,438
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- | - | - | ||||||||||||
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Loss and Comprehensive Loss
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-
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-
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(12,818
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)
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(12,818
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)
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Balance as of June 30, 2024
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237,985
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$
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52,640
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$
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(54,681
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)
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$
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(2,041
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)
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|||||||
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Balance as of January 1, 2025
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1,471,412
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58,275
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(56,451
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)
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$
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1,824
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||||||||||
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Share-based compensation to employees and directors
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-
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396
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-
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396
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Share and warrants issuance to Bladeranger Ltd - DeepSolar asset acquisition (Note 8)
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178,769
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7,292
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-
|
7,292
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||||||||||||
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Issuance of Ordinary shares, net of offering costs – At-the-market (Note 7)
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362,960
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1,247
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-
|
1,247
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Net comprehensive loss
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-
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-
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(2,316
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)
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(2,316
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)
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||||||||||||||||
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Balance as of June 30, 2025
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2,013,141
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$
|
67,210
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$
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(58,767
|
)
|
$
|
8,443
|
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PAINREFORM LTD.
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CONDENSED STATEMENTS OF CASH FLOWS (Unaudited)
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U.S. dollars in thousands
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For the Six Months Ended
June, |
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2025
|
2024
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|||||||
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Cash flows from operating activities
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||||||||
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Net loss
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$
|
(2,316
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)
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$
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(12,818
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)
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||
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Adjustments to reconcile net loss to net cash used in operating activities:
|
||||||||
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Depreciation
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9
|
8
|
||||||
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Exchange rate differences on cash, cash equivalents and restricted cash
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(8
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)
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(3
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)
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||||
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Net change in operating lease asset and liability
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12
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(7
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)
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|||||
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Amortization of intangible assets
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173
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-
|
||||||
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Share-based compensation to employees and directors
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396
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198
|
||||||
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Changes in operating assets and liabilities:
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||||||||
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Prepaid expenses and other current assets
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(258
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)
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1,564
|
|||||
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Trade payables
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(132
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)
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(102
|
)
|
||||
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Employees, related liabilities and accrued expenses
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142
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2,516
|
||||||
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Net cash used in operating activities
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(1,982
|
)
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(8,644
|
)
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||||
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Cash flows from investing activities
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||||||||
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Purchase of property and equipment
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-
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(12
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)
|
|||||
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Bridge loan (Note 14) |
(50 |
) |
- | |||||
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Net cash used in investing activities
|
(50
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) |
(12
|
)
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Cash flows from financing activities
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||||||||
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Proceeds from issuance of shares, warrants and prefunded warrants
|
1,338
|
4,000
|
||||||
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Issuance costs
|
(91
|
)
|
(590
|
)
|
||||
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Net cash provided by financing activities
|
1,247
|
3,410
|
||||||
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Effect of Exchange rate changes on cash, cash equivalents and restricted cash
|
8
|
3
|
||||||
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Change in cash, cash equivalents and restricted cash
|
(777
|
)
|
(5,243
|
)
|
||||
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Cash, cash equivalents and restricted cash at the beginning of the period
|
4,271
|
8,036
|
||||||
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Cash, cash equivalents and restricted cash at the end of the period
|
$
|
3,494
|
$
|
2,793
|
||||
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As of June,
|
||||||||
|
2025
|
2024
|
|||||||
|
Cash and cash equivalents
|
$
|
3,479
|
$
|
2,783
|
||||
|
Restricted cash
|
15
|
10
|
||||||
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Total cash, cash equivalents and restricted cash
|
$
|
3,494
|
$
|
2,793
|
||||
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Acquisition of technology in exchange for equity instruments (Note 8)
|
$
|
7,292
|
$
|
-
|
||||
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Acquisition of right-of-use assets by means of lease liabilities |
$ |
49 | $ | - |
PAINREFORM LTD.
U.S. dollars in thousands, except share and per share data
In March 2025, the Comp any completed an asset acquisition, related to an AI-driven solar analytics technology, DeepSolar, that enables both consumers and enterprises to monitor, forecast, and optimize energy consumption—particularly in solar-integrated environments (see note 8).
In August 2025, the Company closed an investment in LayerBio, Inc.(“Layer Bio”), a privately held Boston-based biotechnology company, advancing sustained-release drug delivery technologies in ophthalmology. With this transaction, the Company acquired a majority equity interest in LayerBio that plans to initiate the next clinical trial of OcuRing™-K, LayerBio’s lead investigational product for pain and inflammation control following cataract surgery.
| a. |
Liquidity
|
| b. |
The Company reports its financial results in U.S. dollars. A portion of research, development, general and administrative expenses of its Israeli operations are incurred in New Israeli Shekel (“NIS”) As a result, the Company is exposed to exchange rate risks that may materially and adversely affect its financial results. If the NIS appreciates against the U.S. dollar, or if the value of the NIS declines against the U.S. dollar at a time when the rate of inflation in the cost of Israeli goods and services exceeds the rate of decline in the relative value of the NIS, then the U.S. dollar-denominated cost of its operations in Israel would increase and its results of operations could be materially and adversely affected.
Inflation in Israel compounds the adverse impact of a devaluation of the NIS against the U.S. dollar by further increasing the amount of its Israeli expenses. Israeli inflation may also (in the future) outweigh the positive effect of any appreciation of the U.S. dollar relative to the NIS, if and to the extent that, it outpaces or precedes such appreciation. The Israeli rate of inflation did not have a material adverse effect on its financial condition during the Six months ended June 30, 2025 and 2024, respectively. Given its general lack of currency hedging arrangements to protect it from fluctuations in the exchange rates of the NIS in relation to the U.S. dollar (and/or from inflation of such non-U.S. currencies), the Company may be exposed to material adverse effects from such movements. The Company cannot predict any future trends in the rate of inflation in Israel or the rate of devaluation (if any) of the U.S. dollar against the NIS. |
F - 6
PAINREFORM LTD.
NOTES TO CONDENSED UNAUDITED FINANCIAL STATEMENTS
U.S. dollars in thousands, except share and per share data
| c. |
U.S. and global markets are experiencing volatility and disruption following the escalation of geopolitical tensions and the military conflict between Russia and Ukraine. The conflict in Ukraine could lead to market disruptions, including significant volatility in commodity prices, credit and capital markets. Any of the abovementioned factors could affect its business, prospects, financial condition, and operating results. The extent and duration of the military action, sanctions and resulting market disruptions are not possible to predict.
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| d. |
On October 7, 2023, an attack was launched against Israel, which thrust Israel into a state of war. The Company's management does not expect this situation to have a material impact on its operations or its business results. As of the date of these financial statements, the war in Israel is ongoing and continues to evolve. The intensity and duration of the war is difficult to predict.
|
Impairment of long-lived assets
The Company tests long-lived assets for impairment whenever events or circumstances indicate the carrying amount may not be recoverable. If the sum of expected future cash flows (undiscounted and without interest charges) of the assets is less than the carrying amount of such assets, an impairment loss would be recognized. The assets would be written down to their estimated fair values, calculated based on the present value of expected future cash flows (discounted cash flows), or some other fair value measure.
F - 7
PAINREFORM LTD.
NOTES TO CONDENSED UNAUDITED FINANCIAL STATEMENTS
U.S. dollars in thousands, except share and per share data
|
|
As of
June 30,
|
As of
December 31,
|
||||||
|
|
2025
|
2024
|
||||||
|
|
||||||||
|
Receivables from governmental authorities
|
$
|
262
|
$
|
119
|
||||
|
Prepaid expenses
|
153
|
38
|
||||||
|
|
||||||||
|
|
$
|
415
|
$
|
157
|
||||
|
|
As of
June 30,
|
As of
December 31,
|
||||||
|
|
2025
|
2024
|
||||||
|
|
||||||||
|
Directors’ fees
|
$
|
21
|
$
|
54
|
||||
|
Manufacturing and trials expenses
|
1,731
|
1,710
|
||||||
|
Advisors and legal expenses
|
79
|
140
|
||||||
|
|
||||||||
|
|
$
|
1,831
|
$
|
1,904
|
||||
F - 8
PAINREFORM LTD.
NOTES TO CONDENSED UNAUDITED FINANCIAL STATEMENTS
U.S. dollars in thousands, except share and per share data
Between January 1, 2025, and June 30, 2025, the Company issued 362,960 ordinary shares through an At-the-Market (ATM) offering, generating gross proceeds of approximately $1.34 million, net of $1.25 million transaction costs.
|
-
|
An increase in the Company’s authorized share capital by an additional 7,500,000 ordinary shares with no par value, subject to approval by the shareholders at a general meeting scheduled for April 3, 2025. Upon approval, the total authorized share capital will be 10,000,000 ordinary shares with no par value.
|
|
-
|
An increase in the Company’s employee option pool to 400,000 options for ordinary shares.
|
F - 9
PAINREFORM LTD.
NOTES TO CONDENSED UNAUDITED FINANCIAL STATEMENTS
U.S. dollars in thousands, except share and per share data
| a. |
Warrants and Warrants units
|
|
Type
|
Issuance Date
|
Number of
warrants
|
Exercise price
|
Exercisable through
|
|
Warrants to underwriters (*)
|
September 3, 2020
|
125,000
|
$2,400.0
|
September 1, 2025
|
|
Warrants to underwriters (*)
|
October 5, 2020
|
375,000
|
$2,112.0
|
September 3, 2025
|
|
IPO warrants (*)
|
September 3, 2020
|
2,812,170
|
$2,112.0
|
September 3, 2025
|
|
PIPE warrants
|
March 11, 2021
|
232,500
|
$1,104.0
|
September 10, 2026
|
|
Warrants to PIPE placement agent
|
March 11,2021
|
52,173
|
$1,214.4
|
March 8, 2026
|
|
December 2023 warrants
|
December 28, 2023
|
32,753
|
$85.4
|
December 28, 2028
|
|
Warrants issued to underwriters
|
April 15, 2024
|
350,000
|
$24.00
|
April 15, 2029
|
|
Warrants issued to underwriters
|
September 11,2024
|
69,251
|
$8.0
|
September 11,2029
|
|
Warrants issued to underwriters
|
December 18, 2024
|
34,625
|
$8.0
|
December 18, 2029
|
|
Pre-funded warrants (Note 8)
|
March 5, 2025
|
223,792
|
$0.01
|
September 5, 2030
|
|
Milestone pre-funded warrants (Note 8)
|
March 5, 2025
|
685,004
|
$0.01
|
September 5, 2030
|
|
Warrant-A issued to Bladeranger (Note 8)
|
March 5, 2025
|
1,087,565
|
$3.1
|
September 5, 2030
|
|
Warrant-B issued to Bladeranger (Note 8)
|
March 5, 2025
|
1,087,565
|
$6.4
|
September 5, 2030
|
|
TOTAL
|
7,167,398
|
(*) At the date of these financial reports, the warrants had expired
| • |
Upon full dilution, the exercise of all outstanding warrants would result in the issuance of an additional 3,166,799 ordinary shares of the Company.
|
| • |
On March 5, 2025 the Company issued shares and warrants as part of an asset acquisition transaction (Note 6)
|
F - 10
PAINREFORM LTD.
NOTES TO CONDENSED UNAUDITED FINANCIAL STATEMENTS
U.S. dollars in thousands, except share and per share data
| b. |
Share-based compensation:
|
| 1. |
The 2008 Plan:
|
|
Number
of options
|
Weighted
average
exercise
price
|
Weighted
average
remaining
contractual
life
|
||||||||||
|
Options outstanding as of December 31,2024
|
22,552
|
$
|
88.32
|
9.17
|
||||||||
|
Options granted
|
197,768
|
(*) |
1.36
|
9.70
|
||||||||
|
Options exercised
|
-
|
-
|
-
|
|||||||||
|
Options expired
|
-
|
-
|
-
|
|||||||||
|
Options outstanding as of June 30, 2025
|
220,320
|
$
|
10.26
|
9.60
|
||||||||
|
Options exercisable as of June 30, 2025
|
128,153
|
$
|
15.22
|
9.49
|
||||||||
|
|
2025
|
2024
|
||||||
|
Expected term (years)
|
5.00-5.81
|
5.00-6.41
|
||||||
|
Risk-free interest rates
|
4.50
|
%
|
4.68
|
%
|
||||
|
Volatility
|
117-120
|
%
|
97.24
|
%
|
||||
|
Dividend yield
|
-
|
-
|
||||||
|
Exercise price
|
$
|
0.01-3.15
|
$ |
6.0
|
||||
As of June 30, 2025, the unrecognized compensation cost related to all unvested 92,167 options granted under the 2019 Plan, was $261, which is expected to be recognized as an expense over a weighted-average period of 3 years.
The Company recognized $389 and $146 during the years ended June 30, 2025, and 2024, respectively, as share-based compensation expenses which was included in general and administrative expenses, and $7 and $52 during the years ended June 30, 2025, and 2024, respectively, as share-based compensation expense which was included in research and development expenses.
F - 11
PAINREFORM LTD.
NOTES TO CONDENSED UNAUDITED FINANCIAL STATEMENTS
U.S. dollars in thousands, except share and per share data
| 1. |
178,769 ordinary shares;
|
| 2. |
223,792 pre-funded warrants;
|
| 3. |
685,004 milestone pre-funded warrants;
|
| 4. |
1,087,565 Warrant-A;
|
| 5. |
1,087,565 Warrant-B.
|
Warrants A to purchase 1,087,565 ordinary shares exercisable upon the achievement of a defined business milestone within 5.5 years from the grant date, at an exercise price equal to the average closing price of the Company’s shares over the five trading days prior to the issuance of such warrants.
Warrants B to purchase 1,087,565 ordinary shares will vest within two years from the Closing Date if either the Company’s share price reaches at least US$15.00, at an exercise price of US$6.40, and will be exercisable for three years following vesting.
F - 12
PAINREFORM LTD.
NOTES TO CONDENSED UNAUDITED FINANCIAL STATEMENTS
U.S. dollars in thousands, except share and per share data
|
NOTE 9: LOSS PER SHARE
Basic loss per share is computed on the basis of the net loss for the period divided by the weighted average number of ordinary shares, prefunded warrants during the period.
Diluted loss per share is based upon the weighted average number of ordinary shares and of potential ordinary shares outstanding when dilutive. Potential ordinary shares include outstanding stock options, and warrants, which are included under the treasury stock method when dilutive.
For the periods ended June 30, 2025, and 2024, all outstanding share options and warrants have been excluded from the calculation of the diluted net loss per share as all such securities are anti-dilutive for all periods presented.
|
F - 13
PAINREFORM LTD.
NOTES TO CONDENSED UNAUDITED FINANCIAL STATEMENTS
U.S. dollars in thousands, except share and per share data
|
Six Months ended
June 30,
|
||||||||
|
2025
|
2024
|
|||||||
|
Bank fees
|
(5
|
)
|
(9
|
)
|
||||
|
Interest income
|
49
|
98
|
||||||
|
Exchange rate differences
|
8
|
3
|
||||||
|
Total financial income, net
|
$
|
52
|
$
|
92
|
||||
Since March 5, 2025, following the acquisition of the solar assets as described in Note 8, the Company identifies and reports two reportable segments: clinical development and solar. The clinical development segment facilitates the development of potential new drug compounds. The solar segment comprises the design, development and sale of the Company’s intellectual property and related service offerings. The Company’s Chief Operating Decision Maker, who is the Chief Executive Officer, manages both segments on an ongoing basis and evaluates performance and allocates resources using the Company’s internal reporting, which is consistent with the presentation in these financial statements. In assessing performance, the CODM considers quantitative and qualitative measures that include segment operating loss and quarterly cash burn together with competitive benchmarking and analyses of budget to actual results. Prior to the acquisition of the solar assets on March 5, 2025, the Company operated and reported a single reportable segment. Comparative prior period segment information has not been recast because the solar operations did not exist in those periods, and the change did not affect the Company’s internal reporting for prior periods. The Company manages its assets on a group basis rather than by segment because many assets are shared across activities. The CODM does not regularly review asset information by segment and accordingly the Company does not present segment of asset information. As of June 30, 2025, and for the six months then ended, no revenue was recognized in either the clinical development or the solar segment.
F - 14
PAINREFORM LTD.
NOTES TO CONDENSED UNAUDITED FINANCIAL STATEMENTS
U.S. dollars in thousands, except share and per share data
|
|
Solar
|
Clinical Development
|
Total
|
|||||||||
|
Payroll and related Expenses
|
$
|
186
|
$
|
420
|
$
|
606
|
||||||
|
Consulting expenses (*)
|
285
|
740
|
1,025
|
|||||||||
|
Other segment items (**)
|
210
|
527
|
737
|
|||||||||
|
|
||||||||||||
|
Segments Operating Loss
|
$
|
681
|
$
|
1,687
|
$
|
2,368
|
||||||
|
Reconciliation between the operating loss of the reporting segments and the total loss for the reporting periods before income tax expense is presented below:
|
||||||||||||
|
Financial income, net
|
$
|
52
|
||||||||||
|
Loss before taxes on income
|
$
|
2,316
|
||||||||||
| 1. |
Between June 30, 2025 and the date of issuance of the financial statements, the Company issued a total of 1,062,199 ordinary shares under its At-the-Market (ATM) offering program, raising aggregate gross proceeds of approximately $2.7 million.
|
| 2. |
On July 10, 2025, the Company entered into a Preferred Stock Purchase Agreement (the “Purchase Agreement”) with LayerBio, Inc. (“LayerBio”) for the acquisition of 7,331,378 preferred shares of LayerBio, representing 51% of the issued and outstanding share capital of LayerBio on a fully diluted basis (the “Acquisition”). On August 13, 2025, the Acquisition closed, making LayerBio a majority-owned subsidiary of the Company. The Company paid $600 at the closing of the Acquisition (net of a $50 bridge loan that the Company previously made to LayerBio in June 2025). The Purchase Agreement further provides for up to $2.4 million of additional potential investment in four tranches, which are contingent upon the achievement of specific milestones related to a planned Phase II clinical trial that LayerBio plans on conducting.
|
|
| 3. |
Between June 30, 2025 and the date of issuance of the financial statements, Bladeranger exercised pre-funded warrants into a total of 840,000 ordinary shares at an exercise price of $0.01 per share. |
|
|
• |
our ability to continue as a going concern;
|
|
|
• |
our history of losses and needs for additional capital to fund our operations and our ability to obtain additional capital on acceptable terms, or at all;
|
|
|
• |
our dependence on the success of our initial product candidate, PRF-110, OcuRing™-K, LayerBio Inc.’s lead product
candidate, and the commercialization of the DeepSolar solution;
|
|
|
• |
the outcomes of preclinical studies, clinical trials and other research regarding PRF-110, OcuRing™-K and future product candidates;
|
|
|
• |
our limited experience managing clinical trials;
|
|
|
• |
our ability to retain key personnel and recruit additional employees;
|
|
|
• |
our reliance on third parties for the conduct of clinical trials, product manufacturing and development;
|
|
|
• |
the impact of competition and new technologies;
|
|
|
• |
our ability to comply with regulatory requirements relating to the development and marketing of our product candidates;
|
|
|
• |
our ability to establish and maintain strategic partnerships and other corporate collaborations;
|
|
|
• |
the implementation of our business model and strategic plans for our business and product candidates;
|
|
|
• |
the scope of protection we are able to establish and maintain for intellectual property rights covering our product candidates and our ability to operate our business without infringing the intellectual property rights of others;
|
|
|
• |
the overall global economic environment;
|
|
|
• |
our ability to maintain the listing of our ordinary shares on the Nasdaq Capital Market;
|
|
|
• |
our ability to develop an active trading market for our ordinary shares and whether the market price of our ordinary shares is volatile;
|
|
|
• |
statements as to the impact of the political and security situation in Israel on our business, including due to the current security situation in Israel; and
|
|
|
• |
those factors referred to in “Risk Factors” as well as in our most recent Annual Report on Form 20-F, or any updates in our Reports on Form 6-K, generally.
|
|
|
● |
incorporate the operations of the DeepSolar business into our operations;
|
|
|
● |
continue the ongoing and planned preclinical and clinical development of our drug candidates;
|
|
|
● |
build a portfolio of drug candidates through the acquisition or in-license of drugs, drug candidates or technologies;
|
|
|
● |
initiate preclinical studies and clinical trials for any additional drug candidates that we may pursue in the future;
|
|
|
● |
seek marketing approvals for our current and future drug candidates that successfully complete clinical trials;
|
|
|
● |
establish a sales, marketing and distribution infrastructure to commercialize any drug candidate for which we may obtain marketing approval;
|
|
|
● |
develop, maintain, expand and protect our intellectual property portfolio;
|
|
|
● |
implement operational, financial and management systems; and
|
|
|
● |
attract, hire and retain additional administrative, clinical, regulatory and scientific personnel.
|
|
|
● |
employee-related expenses, including salaries, benefits and stock-based compensation expense;
|
|
|
● |
fees paid to consultants for services directly related to our drug development and regulatory effort;
|
|
|
● |
expenses incurred under agreements with contract research organizations, as well as CMOs and consultants that conduct preclinical studies and clinical trials;
|
|
|
● |
costs associated with preclinical activities and development activities; and
|
|
|
● |
costs associated with technology and intellectual property licenses.
|
|
●
|
number of clinical trials required for approval and any requirement for extension trials;
|
|
●
|
per patient trial costs;
|
|
●
|
number of patients that participate in the clinical trials;
|
|
●
|
number of sites included in the clinical trials;
|
|
●
|
countries in which the clinical trial is conducted;
|
|
●
|
length of time required to enroll eligible patients;
|
|
●
|
potential additional safety monitoring or other studies requested by regulatory agencies; and
|
|
●
|
efficacy and safety profile of the drug candidate.
|
|
|
Six Months Ended
June 30,
|
|||||||
|
|
2025
|
2024
|
||||||
|
|
(US$ thousands)
|
|||||||
|
Statements of comprehensive loss data:
|
||||||||
|
Amortization of intangible assets
|
$
|
(173
|
)
|
$
|
-
|
|||
|
Research and development
|
(278
|
)
|
(11,407
|
)
|
||||
|
General and administrative
|
(1,917
|
)
|
(1,503
|
)
|
||||
|
Total operating loss
|
(2,368
|
)
|
(12,910
|
)
|
||||
|
Financial income, net
|
52
|
92
|
||||||
|
Net loss
|
(2,316
|
)
|
(12,818
|
)
|
||||
|
|
● |
the costs, timing and outcome of manufacturing clinical trial and commercial quantities of PRF-110 and OcuRing™-K;
|
|
|
● |
the scope, progress, results and costs of our current and future clinical trials of PRF-110 and OcuRing™-K for our current targeted uses;
|
|
●
|
the costs, timing and outcome of regulatory review of PRF-110 and OcuRing™-K;
|
|
|
● |
the extent to which we acquire or invest in businesses, products and technologies, including entering into or maintaining licensing or collaboration arrangements for PRF-110 and OcuRing™-K on favorable terms, although we currently have
no commitments or agreements to complete any such transactions;
|
|
|
● |
the costs and timing of future commercialization activities, including sales, marketing, manufacturing and distribution, for any of our product candidates for which we receive marketing approval, to the extent that such sales, marketing,
manufacturing and distribution are not the responsibility of any collaborator that we may have at such time;
|
|
|
● |
the cost to continue the development of the DeepSolar technology to develop a wider portfolio of solutions;
|
|
|
● |
the cost of establishing a sales, marketing, and technical support infrastructure to support the ramp up of the DeepSolar solution;
|
|
|
● |
the amount of revenue, if any, received from commercial sales of PRF-110 or OcuRing™-K, should it receive marketing approval, or from DeepSolar solution;
|
|
|
● |
the costs of preparing, filing and prosecuting patent applications, maintaining, defending and enforcing our intellectual property rights and defending intellectual property-related claims;
|
|
|
● |
our ability to establish strategic collaborations, licensing or other arrangements and the financial terms of any such agreements, including the timing and amount of any future milestone, royalty or other payments due under any such
agreement;
|
|
|
● |
our headcount growth and associated costs as we expand our business operations and our research and development activities;
|
|
●
|
the costs of operating as a public company;
|
|
●
|
maintaining minimum shareholders’ equity requirements under the Nasdaq rules; and
|
|
|
● |
the impact of the current war between Israel and Hamas which may exacerbate the magnitude of the factors discussed above.
|
|
|
Six months
Ended June 30,
2025
|
Six months
Ended June 30,
2024
|
||||||
|
Net cash used in operating activities
|
$
|
(1,982
|
)
|
$
|
(8,644
|
)
|
||
|
Net cash used in investing activities
|
(50
|
)
|
(12
|
)
|
||||
|
Net cash provided by financing activities
|
1,247
|
3,410
|
||||||
|
Effect of Exchange rate changes on cash, cash equivalents and restricted cash
|
8
|
3
|
||||||
|
Decrease in cash and cash equivalents and restricted cash
|
(777
|
)
|
(5,243
|
)
|
||||
|
Cash and cash equivalents and restricted cash, at the beginning of period
|
4,271
|
8,036
|
||||||
|
Cash and cash equivalents and restricted cash, at the end of period
|
$
|
3,494
|
$
|
2,793
|
||||

|
|
• |
Completed majority investment in LayerBio, adding OcuRing™-K, a breakthrough dropless cataract therapy targeting a ~$9B global market
|
|
|
• |
Advanced PRF-110 with ongoing R&D following partially positive efficacy signals in postoperative pain
|
|
|
• |
Expanded DeepSolar with completion of Smart Energy Management app, acceptance into NVIDIA Connect Program, and successful completion of a 92MW pilot with Econergy that advanced into the Company’s first commercial agreement
|
|
|
• |
Reduced net loss to $2.3M vs. $12.8M in prior-year period; maintained $3.5M cash and positive working capital of $1.5M
|
|
|
• |
LayerBio Acquisition: In August 2025, PainReform completed its strategic investment in LayerBio, Inc., acquiring a majority equity interest. LayerBio’s lead product candidate, OcuRing™-K, is a
sustained-release intraocular ring delivering Ketorolac for pain and inflammation control following cataract surgery. This novel, non-opiate, non-steroidal platform addresses a global market of approximately $9 billion, offering a
single-application, safer and compliance-free solution.
|
|
|
• |
PRF-110: Despite not meeting the primary endpoint in its Phase 3 bunionectomy trial due to data inconsistencies in the final 24-hour period, PRF-110 demonstrated significant efficacy during the
first 48 hours post-surgery. PainReform is conducting additional R&D to refine the pharmacokinetic and pharmacodynamic profile and remains committed to advancing the program.
|
|
|
• |
Smart Energy Expansion: In April 2025, PainReform officially expanded into the Smart Energy Management (SEM) sector, completing the development of MyDeepSolar, a consumer app that optimizes
residential solar efficiency through AI-driven analytics.
|
|
|
• |
NVIDIA Connect Program: In August 2025, DeepSolar was accepted into the NVIDIA Connect Program, providing access to advanced AI tools and frameworks to support the development of DeepSolar Predict,
a next-generation solar forecasting tool expected to improve weather prediction accuracy by up to 50%.
|
|
|
• |
Econergy Pilot and Commercial Transition: In April 2025, the Company launched a 92MW pilot project in Romania with Econergy Renewable Energy. Following successful execution, this engagement
advanced into PainReform’s first post-acquisition commercial customer agreement. The agreement marks DeepSolar’s entry into its initial phase of commercial deployment and establishes a foundation for broader customer adoption.
|