PRF Technologies Ltd 6-K, filed Oct 1, 2025
PRF Technologies Ltd. (PRFX)
6-K
2025-10-01
For: 2025-06-30
View Original
Added on
April 10, 2026
About this 6-K
PRF Technologies Ltd filed this 6-K on October 1, 2025.
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Form 6-K
Report of Foreign Private Issuer
Pursuant to Rule 13a-16 or 15d-16
of the Securities Exchange Act of 1934
of the Securities Exchange Act of 1934
For the month of October 2025
Commission File Number: 001-39481
(Translation of registrant’s name into English)
(Address of principal executive offices)
Indicate by check mark whether the registrant files or will file annual reports under cover Form 20-F or Form 40-F.
Form 20-F ☒ Form 40-F ☐
This Form 6-K, excluding the press release attached hereto as Exhibit 99.3, is incorporated by reference into the Company’s Registration Statements on Form S-8 (Registration No. 333-257968 and 333-265902) and the Company’s Registration Statements on Form F-3 (Registration No. 333-282264, 333-254982, 333-276485, 333-277594, 333-283655 and 333-286941), to be a part thereof from the date on which this report is submitted, to the extent not superseded by documents or reports subsequently filed or furnished. .
On October 1, 2025, PainReform Ltd. (the “Company”) issued a press release announcing its financial results for the six months ended June 30, 2025 . The Company is also publishing its unaudited condensed financial statements, as well as its operating and financial review as of June 30, 2025 and for the six months then ended. Attached hereto are the following exhibits.
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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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In addition, effective September 30, 2025, Professor Eli Hazum resigned from the Company’s Board of Directors due to personal reasons. Professor Hazum’s resignation was not the result of any disagreement with the Company or its management. In his place, Asaf Shavit was appointed to serve as a member of the Board of Directors, effective immediately.
Mr. Shavit has more than 35 years of experience providing audit, tax and financial advisory services to public and private companies, including public corporations and subsidiaries of foreign entities. His areas of expertise include audits of financial statements, budget planning and control, taxation, mergers and acquisitions, corporate liquidations, valuations, and complex cross-border and capital markets transactions. He currently serves as Managing Partner at Moalem-Shavit & Co., Certified Public Accountants, since 1995, where he leads a team of more than 14 professionals. Mr. Shavit holds a B.A. in Accounting, Economics and Business Management and an M.B.A. in Business Management with a concentration in Finance and Banking. He is also a Certified Public Accountant.
Exhibit Index
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Exhibit
No.
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Description
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SIGNATURES
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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Exhibit 99.1
PAINREFORM LTD.
CONDENSED FINANCIAL STATEMENTS
AS OF JUNE 30, 2025
U.S. DOLLARS IN THOUSANDS
UNAUDITED
INDEX
Page | ||
F - 2 | ||
F - 3 | ||
F - 4 | ||
F - 5 | ||
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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$
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|||||||
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Restricted cash
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|||||||||
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Prepaid expenses and other current assets
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4
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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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Intangible assets, net
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8
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||||||||
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Bridge loan
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|||||||||
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Operating lease right of use asset
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6
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Property and equipment, net
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Total long-term assets
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Total assets
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$
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$
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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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$
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Employees and related liabilities
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|||||||||
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Operating lease liability
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6
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Accrued expenses
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5
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Total current liabilities
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Non-current liabilities:
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Provision for uncertain tax positions
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Total non-current liabilities
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|||||||||||
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Total liabilities
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Commitments (Note 10)
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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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7a
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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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|||||||||||
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Total shareholders’ equity
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|||||||||
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|||||||||||
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Total liabilities and shareholders’ equity
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$
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$
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The accompanying notes are an integral part of the unaudited condensed financial statements.
F - 2
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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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|||||||||||
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Operating expenses:
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Amortization of intangible assets
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$
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(
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)
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$
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Research and development expenses
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(
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)
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(
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)
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General and administrative expenses
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(
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)
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(
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)
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|||||||||||
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Operating loss
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(
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)
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(
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)
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Financial income, net
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9
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Net loss and comprehensive loss
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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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Basic and diluted net loss per share
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7
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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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Weighted average number of Ordinary shares used in computing basic and diluted net loss per share
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|||||||||
The accompanying notes are an integral part of the unaudited condensed financial statements.
F - 3
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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
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Total
shareholders’ |
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Number
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Capital
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Deficit
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equity
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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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)
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$
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||||||||
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Share-based compensation to employees and directors
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-
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Share issuance |
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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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||||||||||||||||
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Exercise of prefunded warrants
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Loss and Comprehensive Loss
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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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Balance as of June 30, 2024
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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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||||||||||||||||
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Balance as of January 1, 2025
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(
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)
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$
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Share-based compensation to employees and directors
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-
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Share and warrants issuance to Bladeranger Ltd - DeepSolar asset acquisition (Note 8)
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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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||||||||||||
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Net comprehensive loss
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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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Balance as of June 30, 2025
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$
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$
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(
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)
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$
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||||||||
(*) Represents amount less than $1.
The accompanying notes are an integral part of the unaudited condensed financial statements.
F - 4
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PAINREFORM LTD.
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CONDENSED STATEMENTS OF CASH FLOWS (Unaudited)
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U.S. dollars in thousands
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For the Six Months Ended
June, |
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2025
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2024
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|||||||
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Cash flows from operating activities
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Net loss
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$
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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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Adjustments to reconcile net loss to net cash used in operating activities:
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||||||||
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Depreciation
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||||||
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Exchange rate differences on cash, cash equivalents and restricted cash
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(
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)
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(
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)
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||||
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Net change in operating lease asset and liability
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(
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)
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|||||
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Amortization of intangible assets
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||||||
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Share-based compensation to employees and directors
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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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(
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)
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|||||
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Trade payables
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(
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)
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(
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)
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||||
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Employees, related liabilities and accrued expenses
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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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)
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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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|||||
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Bridge loan (Note 14) |
( |
) |
||||||
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Net cash used in investing activities
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(
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) |
(
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)
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||||
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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
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|
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||||||
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Issuance costs
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(
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)
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(
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)
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||||
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Net cash provided by financing activities
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|
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||||||
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Effect of Exchange rate changes on cash, cash equivalents and restricted cash
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||||||
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Change in cash, cash equivalents and restricted cash
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(
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)
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(
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)
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||||
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Cash, cash equivalents and restricted cash at the beginning of the period
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|
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||||||
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Cash, cash equivalents and restricted cash at the end of the period
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$
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$
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||||
Supplemental cash flow information:
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As of June,
|
||||||||
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2025
|
2024
|
|||||||
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Cash and cash equivalents
|
$
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$
|
|
||||
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Restricted cash
|
|
|
||||||
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Total cash, cash equivalents and restricted cash
|
$
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$
|
|
||||
Investing and Financial activities not involving cash flow:
|
Acquisition of technology in exchange for equity instruments (Note 8)
|
$
|
|
$
|
|
||||
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Acquisition of right-of-use assets by means of lease liabilities |
$ |
$ |
The accompanying notes are an integral part of the unaudited condensed financial statements.
F - 5
PAINREFORM LTD.
NOTES TO CONDENSED UNAUDITED FINANCIAL STATEMENTS
U.S. dollars in thousands, except share and per share data
NOTE 1: GENERAL
PainReform Ltd. (“the Company”) was incorporated and started business operations in November 2007. The Company is a specialty pharmaceutical company focused on the reformulation of established therapeutics. The Company’s proprietary extended-release drug-delivery system is designed to provide an extended period of post-surgical pain relief without the need for repeated dose administration while reducing the potential need for the use of opiates.
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
|
Since its inception, the Company has devoted substantially all its efforts to research and development, clinical trials, and capital raising activities. The Company is still in its development and clinical stage and has not yet generated revenues.
The Company has incurred significant losses and negative cash flows from operations and incurred losses of $2,316 and $12,818 for the six-month periods ended June 30, 2025, and 2024, respectively. During the six months ended June 30, 2025, and 2024, the Company had operating cash outflows of $1,982 and $8,644 , respectively. As of June 30, 2025, the Company had positive working capital of $1,453 . The Company expects to continue to incur losses and negative cash flows from operations until its products reach profitability, if at all. As of June 30, 2025, the Company’s accumulated deficit was $58,767 . The Company has funded its operations to date primarily through equity financing and has cash on hand (including restricted cash) in the amount of $3,494 as of June 30, 2025.
The Company expects to continue incurring losses and negative cash flows from operations until PRF-110, OcuRing™-K and the DeepSolar products reach commercial profitability, if at all. As a result, along with its current cash position, the Company does not have sufficient resources to fund operations nor to continue as a going concern for at least one year from the issuance date of these financial statements.
Management’s plans include continued capital raising through the sale of additional equity securities, debt, or capital inflows from strategic partnerships. There are no assurances, however, that the Company will successfully obtain the level of financing needed for its operations. If the Company is unsuccessful in raising capital, it may need to reduce activities or curtail or abandon some or all of its operations, which could materially harm the Company’s business, financial condition and results of operations. These factors raise substantial doubt about the Company’s ability to continue as a going concern. These financial statements have been prepared assuming that the Company will continue as a going concern, which contemplates the realization of assets and satisfaction of liabilities in the normal course of business and does not include any adjustments that might result from the outcome of this uncertainty.
| 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
NOTE 1: GENERAL (Cont.)
| 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.
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NOTE 2: UNAUDITED CONDENSED FINANCIAL STATEMENTS
The unaudited condensed financial statements included herein have been prepared in accordance with accounting principles generally accepted in the United States (“U.S. GAAP”) and, on the same basis as the audited financial statements included in the Company’s Annual Report on Form 20-F for the fiscal year ended December 31, 2024 (the “2024 Form 20-F”).
Certain information and disclosures normally included in annual financial statements have been omitted in this interim period report pursuant to the rules and regulations of the Securities and Exchange Commission (the “SEC”)” Because the unaudited condensed financial statements do not include all of the information and disclosures required by U.S. GAAP for annual financial statements, they should be read in conjunction with the audited financial statements and notes included in the 2024 Form 20-F.
The year-end balance sheet data were derived from the audited financial statements as of December 31, 2024, but not all disclosures required by U.S. GAAP are included.
In the opinion of management, all adjustments (consisting only of normal recurring accruals) considered necessary for a fair statement of the Company’s financial position as of June 30, 2025 and its results of operations and cash flows for the six months ended June 30, 2025 and 2024 have been included. Operating results for the six months ended June 30, 2025, are not necessarily indicative of the results that may be expected for the year ending December 31, 2025 or any other interim period or for any other future year.
NOTE 3: SIGNIFICANT ACCOUNTING POLICIES
The significant accounting policies that have been applied in the preparation of the unaudited condensed financial statements are consistent with those that were applied in preparation of the Company’s most recent annual financial statements in connection with its Annual Report on Form 20-F, except for the following:
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
NOTE 4: PREPAID EXPENSES AND OTHER CURRENT ASSETS
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As of
June 30,
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As of
December 31,
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|
2025
|
2024
|
||||||
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||||||||
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Receivables from governmental authorities
|
$
|
|
$
|
|
||||
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Prepaid expenses
|
|
|
||||||
|
|
||||||||
|
|
$
|
|
$
|
|
||||
NOTE 5: ACCRUED EXPENSES
|
|
As of
June 30,
|
As of
December 31,
|
||||||
|
|
2025
|
2024
|
||||||
|
|
||||||||
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Directors’ fees
|
$
|
|
$
|
|
||||
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Manufacturing and trials expenses
|
|
|
||||||
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Advisors and legal expenses
|
|
|
||||||
|
|
||||||||
|
|
$
|
|
$
|
|
||||
NOTE 6: RIGHT OF USE ASSETS AND LEASE LIABILITY
F - 8
PAINREFORM LTD.
NOTES TO CONDENSED UNAUDITED FINANCIAL STATEMENTS
U.S. dollars in thousands, except share and per share data
NOTE 7: SHAREHOLDERS’ EQUITY
On January 2, 2025, the Board of Directors of PainReform approved an increase to the Company’s ATM program, pursuant to a written board’s approval dated October 14, 2024. The program allows offerings of up to $4.0 million.
Between January 1, 2025, and June 30, 2025, the Company issued
On February 20, 2025, the Company’s Board of Directors approved the following resolutions:
|
-
|
An increase in the Company’s authorized share capital by an additional
|
|
-
|
An increase in the Company’s employee option pool to
|
F - 9
PAINREFORM LTD.
NOTES TO CONDENSED UNAUDITED FINANCIAL STATEMENTS
U.S. dollars in thousands, except share and per share data
NOTE 7: SHAREHOLDERS’ EQUITY (Cont.)
| a. |
Warrants and Warrants units
|
The following table summarizes the warrants and warrants units outstanding as of June 30, 2025:
|
Type
|
Issuance Date
|
Number of
warrants
|
Exercise price
|
Exercisable through
|
|
Warrants to underwriters (*)
|
|
|
$
|
|
|
Warrants to underwriters (*)
|
|
|
$
|
|
|
IPO warrants (*)
|
|
|
$
|
|
|
PIPE warrants
|
|
|
$
|
|
|
Warrants to PIPE placement agent
|
|
|
$
|
|
|
December 2023 warrants
|
|
|
$
|
|
|
Warrants issued to underwriters
|
|
|
$
|
|
|
Warrants issued to underwriters
|
|
|
$
|
|
|
Warrants issued to underwriters
|
|
|
$
|
|
|
Pre-funded warrants (Note 8)
|
|
|
$
|
|
|
Milestone pre-funded warrants (Note 8)
|
|
|
$
|
|
|
Warrant-A issued to Bladeranger (Note 8)
|
|
|
$
|
|
|
Warrant-B issued to Bladeranger (Note 8)
|
|
|
$
|
|
|
TOTAL
|
|
(*) 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
|
| • |
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
NOTE 7: SHAREHOLDERS’ EQUITY (Cont.)
| b. |
Share-based compensation:
|
| 1. |
The 2008 Plan:
|
The share options were expired without being exercised on April 2, 2024.
The 2019 Plan:
Share options outstanding and exercisable to employees and directors under the 2019 Share Option Plan (the “2019 Plan”) as of June 30, 2025, were as follows:
|
Number
of options
|
Weighted
average
exercise
price
|
Weighted
average
remaining
contractual
life
|
||||||||||
|
Options outstanding as of December 31,2024
|
|
$
|
|
|
||||||||
|
Options granted
|
|
(*) |
|
|
||||||||
|
Options exercised
|
|
|
-
|
|||||||||
|
Options expired
|
|
|
-
|
|||||||||
|
Options outstanding as of June 30, 2025
|
|
$
|
|
|
||||||||
|
Options exercisable as of June 30, 2025
|
|
$
|
|
|
||||||||
(*)On February 20, 2025, the Company’s shareholders approved the grant of 131,568 options to purchase an aggregate of shares to two current board members, and to the chairman of the board of directors. The valuation of the option on the grant date was $443 .
The following table sets forth the assumptions that were used in determining the fair value of options granted in 2025 to employees in 2019 plan for up to June 30, 2025 and 2024.
|
|
2025
|
2024
|
||||||
|
Expected term (years)
|
|
|
||||||
|
Risk-free interest rates
|
|
%
|
|
%
|
||||
|
Volatility
|
|
%
|
|
%
|
||||
|
Dividend yield
|
|
|
||||||
|
Exercise price
|
$
|
|
$ |
|
||||
As of June 30, 2025, the unrecognized compensation cost related to all unvested
The Company recognized $
F - 11
PAINREFORM LTD.
NOTES TO CONDENSED UNAUDITED FINANCIAL STATEMENTS
U.S. dollars in thousands, except share and per share data
NOTE 8: INTANGIBLE ASSET ACQUISITION
On February 17, 2025, the Company entered into an Asset Acquisition Agreement (the “Agreement”) with Bladeranger Ltd. (“Bladeranger”), a public Israeli company, to acquire 100 % of its AI-based solar analytics platform, DeepSolar. The transaction was closed on March 5, 2025.
As consideration, the Company agreed to issue to BLRN the following securities:
| 1. |
|
| 2. |
|
| 3. |
|
| 4. |
|
| 5. |
|
At the initial closing, which took place on May 19, 2025, the Company issued milestone pre-funded warrants exercisable to 685,004 ordinary shares at an exercise price of $0.01 per share.
Warrants A to purchase
Warrants B to purchase
The Company also entered into employment agreements with certain BLRN employees. Under the terms of the Agreement, BLRN and its assignees may not exercise any of the warrants if, following such exercise, their holdings would exceed 9.99 % of the Company’s outstanding ordinary shares.
Accounting treatment
The Company evaluated the transaction under ASC 805, Business Combinations, and concluded that the acquired set of assets and activities does not meet the definition of a business. Accordingly, the transaction was accounted for as an asset acquisition under ASC 805-50.
Fair value measurement
In connection with the acquisition, the Company performed a valuation analysis of the equity instruments issued as consideration and a purchase price allocation (“PPA”) for the acquired assets. The fair value of the consideration transferred, determined based on the fair value of the issued shares and warrants, together with the PPA analysis, was established at $7,292 . In connection with the acquisition, the Company performed a valuation analysis of the equity instruments issued as consideration and a purchase price allocation (“PPA”) for the acquired assets. The valuation applied option pricing models (Black-Scholes and Monte Carlo) for the warrants, incorporating assumptions regarding share price (USD 2.98 ), expected term (5 –5.5 years), risk-free rates (4.1 %), historical volatility (100 %) and milestone achievement probabilities (75 -100 %). The acquired intangible asset was valued using a discounted cash flow approach with a discount rate of 40 %, terminal growth of 3 %.
Useful life and amortization
As of the reporting date, accumulated amortization amounted to $173 thousand, resulting in a net carrying amount of $7,119 thousand for the intangible asset.
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.
|
NOTE 10: COMMITMENTS AND CONTINGENCIES
On August 1, 2023, the Company entered into a one-year lease agreement for its principal offices in Tel Aviv, Israel, later extended to July 31, 2025. As of the reporting date, the Company extends the lease for one year to July 2026 and the Company is exploring alternatives. Monthly rent is $5 , linked to the CPI. In 2025, lease expenses totaled $30 . The weighted average remaining lease term is 1 year, and the discount rate is 8.5 %.
F - 13
PAINREFORM LTD.
NOTES TO CONDENSED UNAUDITED FINANCIAL STATEMENTS
U.S. dollars in thousands, except share and per share data
NOTE 11: FINANCIAL INCOME, NET
|
Six Months ended
June 30,
|
||||||||
|
2025
|
2024
|
|||||||
|
Bank fees
|
(
|
)
|
(
|
)
|
||||
|
Interest income
|
|
|
||||||
|
Exchange rate differences
|
|
|
||||||
|
Total financial income, net
|
$
|
|
$
|
|
||||
NOTE 12: FINANCIAL INSTRUMENTS
The carrying amount of cash equivalents, restricted cash, account payables and accrued expenses approximate their fair value due to their short-term characteristics.
NOTE 13: SEGMENT REPORTING
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
NOTE 13: SEGMENT REPORTING (Cont.)
The following tables presents information on reportable segments profit (loss) for the period ended 30 June 2025:
|
|
Solar
|
Clinical Development
|
Total
|
|||||||||
|
Payroll and related Expenses
|
$
|
|
$
|
|
$
|
|
||||||
|
Consulting expenses (*)
|
|
|
|
|||||||||
|
Other segment items (**)
|
|
|
|
|||||||||
|
|
||||||||||||
|
Segments Operating Loss
|
$
|
|
$
|
|
$
|
|
||||||
|
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
|
$
|
|
||||||||||
|
Loss before taxes on income
|
$
|
|
||||||||||
(*) Consulting expenses items include accounting, legal, and other consulting expenses.
(**) Other Segment items included in operating loss include income tax expenses, Amortization of intangible asset, Share-based compensation expenses, rent and office maintenance expenses, D&O insurance expenses, depreciation expenses and other expenses.
NOTE 14: SUBSEQUENT EVENTS
| 1. |
Between June 30, 2025 and the date of issuance of the financial statements, the Company issued a total of
|
| 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
|
|
| 3. |
Between June 30, 2025 and the date of issuance of the financial statements, Bladeranger exercised pre-funded warrants into a total of |
F - 15
Exhibit 99.2
OPERATING AND FINANCIAL REVIEW AND PROSPECTS
You should read the following selected financial data and discussion of our operating and financial condition and prospects in conjunction with the financial
statements and the notes thereto included elsewhere in this Form 6-K. Our financial statements are prepared in accordance with U.S. GAAP, and reported in U.S. dollars. We maintain our accounting books and records in U.S. dollars and our functional
currency is the U.S. dollar. Certain amounts presented herein may not sum due to rounding. Unless the context requires otherwise, references in this report to “PainReform,” the “Company,” “we,” “us” and “our” refer to PainReform Ltd, an Israeli
company. “NIS” means New Israeli Shekel, and “$,” “US$,” “U.S. dollars” and “USD” mean United States dollars.
Forward Looking Statements
The following discussion contains “forward-looking statements,” including statements regarding expectations, beliefs, intentions or strategies for the future. These statements
may identify important factors which could cause our actual results to differ materially from those indicated by the forward-looking statements. Given these uncertainties, readers are cautioned not to place undue reliance on such forward-looking
statements. Factors that could cause our actual results to differ materially from those expressed or implied in such forward-looking statements include, but are not limited to:
| • |
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.
|
All forward-looking statements attributable to us or persons acting on our behalf speak only as of the date of the Form 6-K to which this discussion is attached and are
expressly qualified in their entirety by the cautionary statements included herein. We undertake no obligations to update or revise forward-looking statements to reflect events or circumstances that arise after the date made or to reflect the
occurrence of unanticipated events. In evaluating forward-looking statements, you should consider these risks and uncertainties.
Overview
We are a specialty pharmaceutical company focused on the reformulation of established therapeutics. Our proprietary extended-release drug-delivery system is designed to provide
an extended period of post-surgical pain relief without the need for repeated dose administration while reducing the potential need for the use of opiates.
Most recently, in August 2025, we closed an investment in LayerBio, Inc., or Layer Bio, a privately held Boston-based
biotechnology company, advancing sustained-release drug delivery technologies in ophthalmology. With this transaction, we 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.
Previously in March 2025, we acquired the business operations related to an AI-driven solar analytics technology, DeepSolar. Through DeepSolar, we also deliver advanced software
solutions that enable both consumers and enterprises to monitor, forecast, and optimize energy consumption—particularly in solar-integrated environments.
PRF-110
PRF-110, our first product candidate, is based on the local anesthetic ropivacaine, targeting the post-operative pain relief market. PRF-110 is an oil-based, viscous, clear
solution that is deposited directly into the surgical wound bed prior to closure to provide localized and extended post-operative analgesia.
In a small, 15-patient Phase 2 proof-of-concept clinical study in hernia repair, PRF-110 provided substantial pain reduction for up to 72 hours post-operatively. A comparison of
these results to historical data for ropivacaine alone suggests a substantial advantage to using PRF-110 over the local analgesic agent, ropivacaine, alone. As indicated in the FDA approved drug description, ropivacaine provides pain relief for
only 2 to 6 hours. The surgeons that participated in the PRF-110 Phase 2 trial reported that it was easily integrated into the procedure and was non-disruptive of existing surgical techniques. Ropivacaine, the active drug used in PRF-110, is a safe
and well-characterized local analgesic agent and the other components that make up the remainder of the PRF-110 formulation are classified as GRAS (Generally Regarded As Safe) by the FDA, mitigating many potential safety issues that are common in
drug development.
In March 2023, we initiated our first Phase 3 clinical trial of PRF-110 in the United States, for pain treatment of patients undergoing bunionectomy, successfully completing the
first part of the Phase 3 clinical study soon thereafter in a PK study of 15 patients undergoing bunionectomy. In June 2024, we completed patient enrollment in our Phase 3 clinical trial for our PRF-110 product. In total, 428 patients were enrolled
at eight clinical sites across the U.S. The primary efficacy endpoint was mean area under the curve, or AUC, of the numerical rating scale, or NRS, of pain intensity scores over 72 hours (AUC0-72) for PRF110 compared with placebo.
In November 2024, we announced that the initial analysis of the topline data indicates that PRF-110 demonstrated statistically significant superiority over placebo in reducing
pain during the first 48 hours following surgery. However, data pertaining to the subsequent 24-hour period, which was essential for assessing the primary endpoint of the trial, was unclear due to incoherence of the data. In December 2024,
following further investigation, we determined that the data from the final 24- hour period could not be clarified to satisfy the study’s primary endpoint 72 hours requirement and therefore it did not meet the primary endpoint of the study. Despite
this setback, we initiated research and development activities to better understand and refine the pharmaco-kinetics and pharmaco-dynamics of PRF-110 based on the data received from the study. These efforts are intended to potentially resolve this
issue to support future clinical trials.
2
OcuRing™-K
On July 10, 2025, we entered into a Preferred Stock Purchase Agreement with LayerBio for the purchase of 7,331,378 shares of preferred stock of LayerBio, which at closing
constituted 51% of the issued and outstanding share capital of LayerBio on a fully diluted basis. The transaction closed in August 2025.
OcuRing™-K, LayerBio’s lead product candidate, is a patent-protected, sustained-release intraocular ring designed to deliver Ketoralac an anti-inflammatory and analgesic drug to
be introduced intra-surgically during cataract procedures. It is a bioerodible implant that offers a transformative alternative to the current standard of care, which commonly relies on frequent topical eye drops, including corticosteroids and
NSAIDs. These prior regimens are poorly absorbed, can be difficult for elderly patients to adhere to, and carry risks of intraocular pressure elevation, delayed wound healing, and systemic side effects.
Unlike traditional treatments, OcuRing™-K provides a single-application, fully “dropless” solution, fully in line with the surgeon’s workflow, designed to deliver controlled,
localized, and extended release of non-opiate and non-steroidal agent therapy directly in the surgical site. This innovative platform eliminates patient compliance issues and reduces the need for multiple medications during the critical
postoperative healing phase, addressing a major unmet need expressed by both patients and providers in the ophthalmic community.
LayerBio's technology allows extended drug release from a single application, minimizing the need for patient-administered drops. Site-specific delivery maximizes local effect
while reducing systemic exposure. Its biodegradable design eliminates the need for removal of the insert, and its versatile drug loading enables the delivery of a wide range of therapeutics (NSAIDs, antibiotics, steroids, anti-VEGF agents).
Together with LayerBio we plan to advance OcuRing™-K through the next stage of clinical development in the U.S., where FDA approval could unlock access to a high-volume,
reimbursable market. In addition to cataract surgery, the companies will explore broader ophthalmic uses, including glaucoma, corneal transplants, and anti-infective applications.
Deep Solar Business
On February 17, 2025, we entered into a business acquisition agreement with BladeRanger Ltd., or BladeRanger, an Israeli technology company established on December 3, 2015,
specializing in innovative solutions to optimize the efficiency and profitability of photovoltaic (PV) solar panels, pursuant to which we acquired 100% of the business activities, software, and knowledge base associated with DeepSolar technology.
The transaction closed on March 5, 2025.
The DeepSolar technology is a cutting-edge AI-powered analytics software that optimizes the efficiency and profitability of solar energy assets. DeepSolar’s software helps solar
system assets owners maximize energy production and increase profitability through an AI based software that monitors and analyzes their solar assets. Its technology integrates seamlessly with supervisory control and data analytics (SCADA) systems
via a centralized dashboard, offering monitoring, performance analytics, and automated maintenance solutions. The DeepSolar technology extracts the data and analyzes it, while providing actionable insights that help boost productivity and enhance
control through automatic tools for daily monitoring and reporting and with top-down and bottom-up operational dashboards.
Active in both the business to business and business-to-business-to-consumer (B2B2C) sectors, where we provide solutions directly to commercial partners and solar
operators who, in turn, serve end-consumers. DeepSolar aims to provide enterprise-level solutions for large-scale solar operators and residential applications for individual homeowners. In the commercial sector, our technology helps solar farms
reduce operational inefficiencies and increase energy output. In the residential market, its mobile app, MyDeepSolar, empowers homeowners to optimize their solar investments, detect inefficiencies, and reduce energy costs. The DeepSolar
technology can cut operational costs while maximizing energy production, presenting a significant market opportunity across multiple verticals.
In March 2025, the Company signed its first customer agreement since the acquisition and expanded DeepSolar’s pipeline. In addition, we launched a new reporting module that delivers plant
insights across different lifecycle stages, such as post-commissioning and EPC warranty expiration. In parallel, we advanced research and POCs to adapt the product to market needs, further strengthening DeepSolar’s differentiation and growth
potential. We are still in the very early stages of commercializing the DeepSolar solution having generated limited revenue to date.
3
Since our inception in November 2007, we have devoted substantially all of our efforts to organizing and planning our business, building our management and technical team,
developing our proprietary drug delivery system and PRF-110, and raising capital.
We have not generated any significant revenue and have funded our business primarily through the sale of our ordinary shares, warrants and issuance of convertible loans.
We expect to continue to incur significant expenses and increasing losses for the next several years. Our net losses may fluctuate significantly from period to period, depending
on the timing of our planned clinical trials and expenditures on our other research and development and commercial development activities. We expect our expenses will increase substantially over time as we:
| ● |
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.
|
Financial Operations Overview
Revenue
We have not generated any significant revenue to date and do not expect to generate any revenue from our drug development business unless or until we obtain regulatory approval and
commercialize one or more of our current or future drug candidates. In the future, we may also seek to generate revenue from a combination of research and development payments, license fees and other upfront or milestone payments. We expect to
generate revenue in the future from the commercialization of the DeepSolar.
4
Research and Development Expenses
Research and development expenses consist primarily of costs incurred for our research activities, which include, among other things:
| ● |
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.
|
Costs incurred in connection with research and development activities are expensed as incurred. Costs for certain development activities, such as clinical trials, are recognized
based on an evaluation of the progress to completion of specific tasks using data such as patient enrollment, clinical site activations or other information provided to us by our vendors.
Research and development activities are and will continue to be central to our business model. We expect our research and development expenses to increase for the foreseeable
future as we advance our current and future drug candidates through preclinical studies and clinical trials. The process of conducting preclinical studies and clinical trials necessary to obtain regulatory approval is costly and time-consuming. It
is difficult to determine with certainty the duration and costs of any preclinical study or clinical trial that we may conduct. The duration, costs and timing of clinical trial programs and development of our current and future drug candidates will
depend on a variety of factors that include, but are not limited to, the following:
|
●
|
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.
|
In addition, the probability of success for any of our current or future drug candidates will depend on numerous factors, including competition, manufacturing capability and
commercial viability. We will determine which programs to pursue and how much to fund each program in response to the scientific and clinical success of each drug candidate, as well as an assessment of each drug candidate’s commercial potential.
General and Administrative Expenses
General and administrative expenses consist primarily of employee-related expenses, including salaries, benefits and share-based compensation. Other general and administrative
expenses include directors’ and officers’ liability insurance premiums, costs associated with being a publicly traded company, fees associated with investor relations, professional fees for consultants, tax and legal services and facility-related
costs.
We expect that general and administrative expenses will increase in the future as we expand our operating activities and incur additional costs. In addition, if our current or
future drug candidates are approved for sale, we expect that we will incur expenses associated with building our commercial and distribution infrastructure.
5
Financial Income (Expenses), Net
Financial (income) expenses, net, primarily consists of interest from deposits, Issuance costs of warrants, change in fair value of derivative warrant liability, losses from
warrants issuing, bank management fees and commissions and exchange rate differences expenses.
Results of Operations
The table below provides our results of operations for the six months ended June 30, 2025 and 2024.
|
|
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
|
)
|
||||
Research and development expenses. Research and development expenses were $278,000 for the six months ended June 30, 2025 compared to
$11.4 million for the six months ended June 30, 2024, a decrease of $11.4 million. The decrease was primarily due to the finalization of the Phase 3 clinical trial evaluating PRF-110 in 2024.
General and administrative expenses. General and administrative expenses were $1.9 million for the six months ended June 30, 2025
compared to $1.5 million for the six months ended June 30, 2024. The increase of $0.4 million in general and administrative expenses is primarily due to an increase in legal costs and share based options costs.
Financial income, net. Financial income, net was $52,000 for the six months ended June 30, 2025 compared to $92,000 financial income, net
for the six months ended June 30, 2024. The decrease was primarily due to a decrease in cash and equivalents.
Net loss. As a result of the foregoing, we incurred a net loss of $2.3 million for the six months ended June 30, 2025 compared to a net
loss of $12.8 million for the six months ended June 30, 2024, a decrease of $10.5 million. The decrease was primarily due to the finalization of the Phase 3 clinical trial evaluating PRF-110.
Liquidity and Capital Resources
Since our inception, we have devoted substantially all of our efforts to research and development, clinical trials, and capital raising activities. We are still in our
development stage with respect to our development of PRF-110 and OcuRing™-K and have not yet generated revenues from our drug development business. Developing drugs, conducting clinical trials and commercializing products is expensive and we will
need to raise substantial additional funds to achieve our strategic objectives. We not yet generated significant revenues from the commercialization of Deep Solar.
We have incurred significant losses and negative cash flows from operations since our inception. For the six months ended June 30, 2025, and 2024 we incurred losses of $2.3
million, and $12.8 million, respectively, and had negative operating cash outflows of $2.0 million, and $8.6 million for the six months ended June 30, 2025 and 2024 respectively. As of June 30, 2025, we had an accumulated deficit of approximately
$58.8 million. We have funded our operations to date primarily through equity financings and, as of June 30, 2025, we had cash and cash equivalents (including restricted cash) of approximately $3.5 million and a positive working capital of
approximately $1.5 million.
In October 2024, we entered into an At The Market Offering Agreement, or the ATM Agreement, with H.C. Wainwright & Co.,
LLC, as sales agent pursuant to which we may offer and sell, from time to time through the sales agent our ordinary shares up to $1.35 million. In January 2025, we increased the at-the-market equity program by an additional $4 million. As of
September 30, 2025, we sold 1,768,361 shares pursuant to the ATM Agreement for aggregate gross proceeds of approximately $5.35 million.
6
We have incurred and expect to continue incurring losses, and negative cash flows from operations until our product, PRF-110, OcuRing™-K and the DeepSolar solution,
reaches commercial profitability. As a result of these expected losses and negative cash flows from operations, based on our current cash position and projected operating requirements, there is uncertainty regarding our ability to meet our
financial obligations for at least the next 12 months. While our management is actively exploring various financing and strategic alternatives, there can be no assurance that such measures will be successful in alleviating this uncertainty. As a
result, we will be required to raise additional capital in the future to support our operations. Therefore, there is substantial doubt about our ability to continue as a going concern.
Management’s plans include raising capital through the sale of additional equity securities, debt or capital inflows from strategic partnerships and generating revenues from the
commercialization of the DeepSolar solution. There are no assurances, however, that we will successfully obtain the level of financing needed for our operations. If we are unsuccessful in raising capital, we may need to reduce activities, curtail,
or abandon some or all of our operations, which could materially harm our business, financial condition and results of operations.
Substantial Doubt About Ability to Continue as a Going Concern
These factors raise substantial doubt on our ability to continue to operate as a going concern. The financial statements have been prepared assuming that we will continue as a
going concern and do not include any adjustments that might result from the outcome of this uncertainty.
Our estimate as to how long we expect our funds to support our operations is based on assumptions that may prove to be wrong, and we could exhaust our available capital resources
sooner than we currently expect. Further, changing circumstances, some of which may be beyond our control, could cause us to consume capital significantly faster than we currently anticipate, and we may need to seek additional funds sooner than
planned. Our future capital requirements will depend on many factors, including:
| ● |
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;
|
7
| ● |
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.
|
We expect our expenses to increase in connection with our planned operations. Until such time, if ever, as we can generate substantial revenues, we expect to finance our cash
needs through a combination of equity offerings, debt financings, collaborations, strategic alliances and/or licensing arrangements. To the extent that we raise additional capital through the sale of equity or convertible debt securities, your
ownership interest may be diluted, and the terms of these securities could include liquidation or other preferences and anti-dilution protections that could adversely affect your rights as a shareholder. In addition, debt financing, if available,
would result in fixed payment obligations and may involve agreements that include restrictive covenants that limit our ability to take specific actions, such as incurring additional debt, making capital expenditures, creating liens, redeeming
shares or declaring dividends, that could adversely impact our ability to conduct our business. In addition, securing financing could require a substantial amount of time and attention from our management and may divert a disproportionate amount of
their attention away from day-to-day activities, which may adversely affect our management’s ability to oversee the development of our product candidates.
If we raise additional funds through collaborations, strategic alliances or licensing arrangements with third parties, we may have to relinquish valuable rights to our
technology, future revenue streams or product candidates or grant licenses on terms that may not be favorable to us. If we are unable to raise additional funds when needed, we may be required to delay, reduce and/or eliminate our product candidate
development or future commercialization efforts or grant rights to develop and market product candidates that we would otherwise prefer to develop and market ourselves.
Cash Flows
The following table sets forth the major components of our statements of cash flows for the periods presented (U.S. dollars in thousands):
|
|
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
|
||||
8
Net cash used in operating activities
For the six months ended June 30, 2025 and 2024, net cash used in operating activities was $2.0 million and $8.6 million, respectively. The decrease reflects the completion of
significant trial-related expenditures that had impacted 2024 results.
Net cash used in investing activities
For the six months ended June 30, 2025, net cash used by investing activities was $50,000, compared to net cash used in investing activities of $12,000 in the
six months ended June 2024. The change was due to a short term bridge loan given to LayerBio.
Net cash provided by financing activities
For the six months ended June 30, 2025 net cash provided by financing activities was $1.3 million compared to $3.4 million as of June 30, 2024 due to raising
higher funds in the six months of 2024.
Trend Information.
We are in a development stage with regard to drug development and early commercialization with respect to our DeepSolar technology. It is not possible for us to predict with any
degree of accuracy the outcome of our research, development, or commercialization efforts. As such, it is not possible for us to predict with any degree of accuracy any known trends, uncertainties, demands, commitments or events that are reasonably
likely to have a material effect on our net sales or revenues, income from continuing operations, profitability, liquidity or capital resources, or that would cause reported financial information to not necessarily be indicative of future operating
results or financial condition. However, to the extent possible, certain trends, uncertainties, demands, commitments and events are in this “Operating and Financial Review and Prospects.”
Off-Balance Sheet Arrangements.
We did not have during the periods presented, and we do not currently have, any off-balance sheet arrangements, as defined in the rules and regulations of the SEC.
Critical Accounting Policies and Judgments and Estimates
Our statements are prepared in accordance with GAAP. Some of the accounting methods and policies used in preparing our financial statements under GAAP are based on complex and
subjective assessments by our management or on estimates based on past experience and assumptions deemed realistic and reasonable based on the circumstances concerned. The actual value of our assets, liabilities and shareholders’ equity and of our
accumulated deficit could differ from the value derived from these estimates if conditions change and these changes have an impact on the assumptions adopted. See Note 3 to the accompanying financial statements.
9
Exhibit 99.3
PainReform Provides Business Update for the Six Months Ended June 30, 2025
Tel Aviv – October 1, 2025 — PainReform Ltd. (Nasdaq: PRFX), a specialty pharmaceutical company focused on the reformulation of established
therapeutics and commercialization of AI-driven solar analytics technologies, today provided a business update for the six months ended June 30, 2025.
Key Highlights:
| • |
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
|
Ehud Geller, Chairman and interim Chief Executive Officer of PainReform, stated, "The first half of 2025 has been transformational for PainReform as we advanced our dual strategy in specialty
pharmaceuticals and renewable energy technologies. On the pharmaceutical side, we strengthened our pipeline with the acquisition of a majority interest in LayerBio and its OcuRing™-K platform, a breakthrough ‘dropless’ therapy designed to address
post-surgical pain and inflammation following cataract surgery. Together with continued development work on PRF-110, which demonstrated meaningful efficacy in the early part of the postoperative period, we are expanding our portfolio of non-opioid
solutions to meet significant clinical needs in large, global markets."
"In parallel, our DeepSolar division continues to demonstrate strong momentum and commercial promise. Highlights from the first half of the year include the completion of the MyDeepSolar consumer
app, acceptance into NVIDIA’s Connect Program to accelerate the development of our DeepSolar Predict forecasting solution, and the successful completion of our 92MW pilot project with Econergy in Romania, which advanced into our first commercial
customer agreement. This agreement marks DeepSolar’s transition from pilot stage into its initial phase of commercial deployment. While still in the early stages, this milestone provides a foundation for scaling the platform with additional
customers and projects, demonstrating its potential to become a meaningful contributor to long-term growth and shareholder value."
"At the same time, we are committed to maintaining financial discipline and resource efficiency. Operating expenses declined meaningfully compared to the prior year period , and we significantly
reduced our net loss while preserving a solid working capital position. As we pursue growth opportunities, we will continue to balance innovation with careful expense management and sound execution. This prudent approach is central to our strategy
of building sustainable value across both our healthcare and clean energy businesses."
Business Highlights
Pharmaceutical Programs
| • |
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.
|
DeepSolar Division
| • |
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.
|
Financial Results for the Six Months Ended June 30, 2025
Research and development expenses were approximately $0.3 million for the six months ended June 30, 2025, compared to approximately $11.4 million for the six months ended June 30, 2024. The
decrease was primarily due to the completion of the Phase 3 clinical trial evaluating PRF-110 in 2024.
General and administrative expenses were approximately $1.9 million for the six months ended June 30, 2025, compared to approximately $1.5 million for the six months ended June 30, 2024. The
increase was mainly due to higher legal costs and share-based compensation expenses.
Financial income, net, was approximately $52,000 for the six months ended June 30, 2025, compared to approximately $92,000 for the six months ended June 30, 2024. The decrease was primarily due to
lower cash balances in 2025.
Net loss for the six months ended June 30, 2025, was approximately $2.3 million, compared to a net loss of approximately $12.8 million for the six months ended June 30, 2024.
As of June 30, 2025, the Company had cash and cash equivalents (including restricted cash) of approximately $3.5 million and a positive working capital of approximately $1.5 million.
About PainReform
PainReform Ltd. (Nasdaq: PRFX) is a company focused on the reformulation of established therapeutics, and a developer of AI-driven energy optimization technologies through its DeepSolar platform.
The Company’s pharmaceutical programs leverage a proprietary extended-release drug-delivery system intended to provide prolonged post-surgical pain relief while minimizing the need for repeated dosing and reducing reliance on opioids. Through
DeepSolar, PainReform also delivers advanced software solutions that enable both consumers and enterprises to monitor, forecast, and optimize energy consumption—particularly in solar-integrated environments. This dual business model reflects
PainReform’s strategic commitment to applying precision technology across high-impact sectors including healthcare and sustainable energy. For more information, please visit www.painreform.com.
Notice Regarding Forward-Looking Statements
This press release contains
forward-looking statements about PainReform’s expectations, beliefs and intentions including with respect to the potential of the DeepSolar business unit and the potential of the OcuRing™-K platform t. Forward-looking statements can be identified by the use of forward-looking words such as "believe", "expect", "intend", "plan", "may", "should", "could", "might",
"seek", "target", "will", "project", "forecast", "continue" or "anticipate" or their negatives or variations of these words or other comparable words or by the fact that these statements do not relate strictly to historical matters. These
forward-looking statements are based on assumptions and assessments made in light of management's experience and perception of historical trends, current conditions, expected future developments and other factors believed to be appropriate.
Forward-looking statements in this press release are made as of the date of this press release, and we undertake no duty to update or revise any such statements, whether as a result of new information, future events or otherwise.
Forward-looking statements are not guarantees of future performance and are subject to risks and uncertainties, many of which are outside of our control. Many factors could cause our actual activities or results to differ materially from the
activities and results anticipated in forward- looking statements, including, but not limited to, the following: our ability to continue as a going concern, our history of significant losses, our need to raise additional capital 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 and our ability to operate our business without infringing the intellectual property rights of others; the overall global economic
environment; our ability to develop an active trading market for our ordinary shares and whether the market price of our ordinary shares is volatile; our ability to maintain our listing on the Nasdaq Capital Market; and statements as to the
impact of the political and security situation in Israel on our business, including due to the current war in Israel. More detailed information about the risks and uncertainties affecting us is contained under the heading "Risk Factors"
included in the Company's most recent Annual Report on Form 20-F and in other filings that we have made and may make with the Securities and Exchange Commission in the future.
Contact:
Crescendo Communications, LLC
Tel: 212-671-1021
Email: prfx@crescendo-ir.com
Dr. Ehud Geller
Chairman and interim Chief Executive Officer
PainReform Ltd.
Tel: +972-54-4236711
Email: egeller@medicavp.com