ISCO 10-Q
International Stem Cell CORP (ISCO)
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM
QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the quarterly period ended
or
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the transition period from __________ to __________
Commission File Number:
(Exact name of registrant as specified in its charter)
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Securities registered pursuant to Section 12(b) of the Act:
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Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.
Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files).
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.
Large accelerated filer |
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Emerging growth company |
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If an emerging growth company, indicate by check mark if the registrant elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No
As of August 11, 2026, the Registrant had
International Stem Cell Corporation and Subsidiaries
Form 10-Q
Table of Contents
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Page Numbers |
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Item 1. |
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3 |
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Condensed Consolidated Balance Sheets as of June 30, 2026 (Unaudited) and December 31, 2025 |
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3 |
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4 |
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5 |
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6 |
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Notes to Condensed Consolidated Financial Statements (Unaudited) |
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Item 2. |
Management’s Discussion and Analysis of Financial Condition and Results of Operations |
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Item 3. |
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27 |
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Item 4. |
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27 |
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Item 1. |
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29 |
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Item 1A. |
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29 |
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Item 2. |
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31 |
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Item 3. |
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31 |
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Item 4. |
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31 |
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Item 5. |
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31 |
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Item 6. |
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32 |
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34 |
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2
PART I – FINANCIAL INFORMATION
Item 1. Condensed Consolidated Financial Statements
International Stem Cell Corporation and Subsidiaries
Condensed Consolidated Balance Sheets
(In thousands, except share and par value data)
(Unaudited)
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June 30, |
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December 31, |
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2026 |
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2025 |
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Assets |
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Current assets: |
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Cash |
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$ |
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$ |
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Accounts receivable, net |
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Inventories |
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Prepaid expenses and other current assets |
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Total current assets |
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Non-current inventories |
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Property and equipment, net |
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Intangible assets, net |
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Right-of-use assets |
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Deposits and other assets |
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Total assets |
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$ |
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$ |
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Liabilities, Redeemable Convertible Preferred Stock and Stockholders' Deficit |
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Current liabilities: |
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Accounts payable |
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$ |
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$ |
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Accrued liabilities |
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Operating lease liabilities, current |
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Advances |
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Total current liabilities |
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Operating lease liabilities, net of current portion |
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Total liabilities |
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Series D redeemable convertible preferred stock, $ |
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Stockholders' Deficit: |
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Non-redeemable convertible preferred stock, $ |
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Common stock, $ |
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Additional paid-in capital |
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Accumulated deficit |
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( |
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Total stockholders' deficit |
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( |
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Total liabilities, redeemable convertible preferred stock and stockholders' deficit |
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$ |
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$ |
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See accompanying notes to the unaudited condensed consolidated financial statements.
3
International Stem Cell Corporation and Subsidiaries
Condensed Consolidated Statements of Operations
(In thousands, except share and per share data)
(Unaudited)
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Three Months Ended June 30, |
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Six Months Ended June 30, |
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2026 |
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2025 |
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2026 |
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2025 |
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$ |
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$ |
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$ |
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$ |
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Operating expenses: |
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Cost of sales |
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General and administrative |
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Selling and marketing |
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Research and development |
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Total operating expenses |
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Income (loss) from operations |
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( |
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( |
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( |
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Other income (expense): |
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Interest expense |
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Interest expense - related party |
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( |
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( |
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( |
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( |
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Other (expense) income |
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( |
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— |
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— |
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Total other expense, net |
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( |
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( |
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( |
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( |
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Net income (loss) |
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( |
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( |
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Undistributed earnings allocated to participating securities |
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— |
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( |
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— |
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— |
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Net income (loss) allocable to common stockholders |
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$ |
( |
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$ |
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$ |
( |
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$ |
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Net income (loss) per common share, basic and diluted |
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$ |
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$ |
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$ |
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$ |
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Weighted-average common shares used to compute |
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See accompanying notes to the unaudited condensed consolidated financial statements.
4
International Stem Cell Corporation and Subsidiaries
Condensed Consolidated Statements of Changes in Redeemable Convertible
Preferred Stock and Stockholders’ Deficit
(In thousands)
(Unaudited)
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Three and Six Months Ended June 30, 2026 |
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Series D Redeemable |
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Non-redeemable |
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Convertible |
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Convertible |
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Common |
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Additional |
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Total |
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Preferred Stock |
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Preferred Stock |
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Stock |
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Paid-in |
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Accumulated |
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Stockholders' |
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Shares |
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Amount |
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Shares |
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Amount |
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Shares |
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Amount |
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Capital |
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Deficit |
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Deficit |
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Balance at December 31, 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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$ |
( |
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$ |
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Stock-based compensation |
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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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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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( |
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( |
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Balance at March 31, 2026 |
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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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Stock-based compensation |
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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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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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( |
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( |
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Balance at June 30, 2026 |
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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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Three and Six Months Ended June 30, 2025 |
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Series D Redeemable |
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Non-redeemable |
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Convertible |
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Convertible |
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Common |
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Additional |
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Total |
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Preferred Stock |
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Preferred Stock |
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Stock |
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Paid-in |
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Accumulated |
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Stockholders' |
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Shares |
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Amount |
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Shares |
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Amount |
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Shares |
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Amount |
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Capital |
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Deficit |
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Deficit |
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Balance at December 31, 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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Stock-based compensation |
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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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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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( |
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( |
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Balance at March 31, 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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$ |
( |
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$ |
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Stock-based compensation |
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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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Net income |
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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 at 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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$ |
( |
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$ |
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See accompanying notes to the unaudited condensed consolidated financial statements.
5
International Stem Cell Corporation and Subsidiaries
Condensed Consolidated Statements of Cash Flows
(In thousands)
(Unaudited)
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Six Months Ended June 30, |
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2026 |
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2025 |
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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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Adjustments to reconcile net loss to net cash provided by (used in) operating |
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Stock-based compensation |
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Depreciation and amortization |
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Non-cash operating lease expense |
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Interest expense on related party note payable |
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Change in inventory reserve |
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Impairment of intangible assets |
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— |
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Changes in operating assets and liabilities: |
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Accounts receivable |
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( |
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( |
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Inventories |
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( |
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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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Accounts payable |
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Accrued liabilities |
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Operating lease liabilities |
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( |
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( |
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Net cash provided by (used in) operating activities |
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Cash flows from investing activities |
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Purchases of property and equipment |
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( |
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Payments for patent licenses |
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( |
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— |
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Net cash used in investing activities |
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( |
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Cash flows from financing activities |
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Payments on related party note payable |
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( |
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( |
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Net cash used in financing activities |
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( |
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( |
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Net increase (decrease) in cash |
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( |
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Cash, beginning of period |
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Cash, end of period |
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$ |
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$ |
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Supplemental disclosure of non-cash operating activities: |
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Operating lease right-of-use asset obtained in exchange for operating lease liabilities |
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$ |
— |
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$ |
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Supplemental disclosure of cash flow information: |
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Cash paid for interest |
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$ |
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$ |
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See accompanying notes to the unaudited condensed consolidated financial statements.
6
International Stem Cell Corporation and Subsidiaries
Notes to Condensed Consolidated Financial Statements
(Unaudited)
1. Description of Business, Basis of Presentation, and Summary of Significant Accounting Policies
Description of Business
International Stem Cell Corporation (the “Company”) was organized in Delaware in June 2005 and is headquartered in San Diego, California. The Company is primarily a research and development company for the therapeutic market, which has focused on advancing potential clinical applications of human parthenogenetic stem cells (“hpSCs”) for the treatment of various diseases of the central nervous system and liver. The Company has the following wholly owned subsidiaries:
Basis of Presentation
The accompanying unaudited condensed consolidated financial statements have been prepared in accordance with U.S. generally accepted accounting principles (“GAAP”) and the rules and regulations of the U.S. Securities and Exchange Commission (the “SEC”) applicable to interim financial statements. Certain information and notes normally included in annual financial statements prepared in accordance with GAAP have been condensed or omitted pursuant to those rules and regulations. The unaudited interim condensed consolidated financial statements reflect all adjustments consisting of normal recurring adjustments which, in the opinion of management, are necessary for a fair statement of the Company’s condensed consolidated financial statements. The operating results for the three and six months ended June 30, 2026 are not necessarily indicative of the results that may be expected for the full year ending December 31, 2026. The condensed consolidated financial statements should be read in conjunction with the audited consolidated financial statements and the notes thereto for the year ended December 31, 2025 included in the Company’s annual report on Form 10-K filed with the SEC on March 30, 2026.
Going Concern
The Company had an accumulated deficit of approximately $
There can be no assurance that the Company will be successful in maintaining normal operating cash flow or obtaining additional funding. These circumstances raise substantial doubt about the Company’s ability to continue as a going concern. For the foreseeable future, the Company’s ability to continue its operations is dependent upon its ability to obtain additional financing or to extend the maturity on its existing financing. The accompanying condensed consolidated financial statements do not include any adjustments to reflect the possible future effects on the recoverability and classification of assets or the amounts and classifications of liabilities that may result from the outcome of the uncertainty concerning the Company’s ability to continue as a going concern.
The Company continues to evaluate various financing sources and options to raise working capital to help fund current research and development programs and operations. The Company plans to obtain significant additional funding from sources, including through debt and equity financing, license arrangements, grants and/or collaborative research arrangements to sustain its operations and develop products.
The timing and degree of any future capital requirements will depend on several factors, including:
7
Additional debt financing may be expensive and require the Company to pledge all or a substantial portion of its assets. If additional funds are obtained through arrangements with collaborative partners, these arrangements may require the Company to relinquish the rights to some of its technologies, product candidates, or products that the Company would otherwise seek to develop and commercialize on its own. Furthermore, if sufficient capital is not available, the Company may be required to delay, reduce the scope of, or eliminate one or more of its product initiatives. The Company’s failure to raise capital or enter into related arrangements when needed would have a negative impact on its financial condition.
Principles of Consolidation and Foreign Currency Transactions
The condensed consolidated financial statements include the accounts of International Stem Cell Corporation and its wholly owned subsidiaries. All intercompany balances and transactions have been eliminated in consolidation. The functional currency of the Company and its wholly owned subsidiaries is the U.S. dollar. Monetary assets and liabilities that are not denominated in the functional currency are remeasured each reporting period into U.S. dollars at foreign currency exchange rates in effect at the respective balance sheet date. Non-monetary assets and liabilities and equity are remeasured at the historical exchange rates. Revenue and expenses are remeasured at the average rate in effect on the date of the transaction. Net realized and unrealized gains and losses from foreign currency transactions and remeasurement are reported in general and administrative expense in the accompanying condensed consolidated statements of operations and were not material for the periods presented.
Use of Estimates
The preparation of condensed consolidated financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the amounts reported in the condensed consolidated financial statements and accompanying notes. Significant estimates include patent life (remaining legal life versus remaining useful life), inventories carrying values, and the fair value of stock option grants using the Black-Scholes option valuation model. By their nature, estimates are subject to an inherent degree of uncertainty and actual results could differ from these estimates.
Segments
The Company’s chief operating decision maker reviews financial information presented on a consolidated basis, accompanied by disaggregated information by each reportable segment’s statement of operations. The Company operates the business on the basis of
Inventories
Inventories are accounted for using the average cost and first-in, first-out (“FIFO”) methods for LCT cell culture media and reagents, specific identification method for other LCT products, and average cost and specific identification methods for LSC products. Inventories are stated at the lower of cost or net realizable value. Laboratory supplies used in the research and development process are expensed as consumed. LCT’s inventories have a long product life cycle, do not have a shelf life when frozen, and future demand is uncertain. As such, at each reporting period, the Company estimates its reserve allowance for excess and obsolete inventories using historical sales data and inventory turnover rates. The establishment of a reserve for excess and obsolete inventories establishes a new cost basis in inventories, and charges are not reversed subsequently to income, even if circumstances later suggest that increased carrying amounts are recoverable. If the Company is able to sell such inventories, any related reserves would be reduced in the period of sale. The value of the inventories that are not expected to be sold within one year of the current reporting period is classified as non-current inventories on the accompanying condensed consolidated balance sheets.
Accounts Receivable, net
Trade accounts receivable are recorded at the net invoice value and are not interest bearing. Accounts receivable primarily consist of trade accounts receivable from the sales of LCT’s products, as well as LSC trade receivable amounts related to spa and distributor sales. The Company considers receivables past due based on the contractual payment terms. The Company measures expected credit losses for financial instruments at each reporting date based on historical experience, current conditions, and reasonable forecasts. The allowance for credit losses represents the Company’s estimate of expected credit losses relating to these factors. Amounts are written off against the allowance for credit losses when the Company determines that a customer account is uncollectible. As of June 30, 2026 and December 31, 2025, the Company’s allowance for credit losses was immaterial.
8
Property and Equipment, net
Property and equipment are stated at cost. The provision for depreciation and amortization is computed using the straight-line method over the estimated useful lives of the assets, which are generally to
Intangible Assets, net
Intangible assets consist of acquired patent licenses and capitalized legal fees related to the acquisition, filing, maintenance, and defense of patents and trademarks. Amortization begins once the patent is issued by the appropriate authoritative bodies. In the period in which a patent application is rejected or efforts to pursue the patent are abandoned, all the related accumulated costs are expensed. Patents and other intangible assets are amortized on a straight-line basis over the shorter of the useful life of the underlying patent, which is generally
Leases
The Company determines if an arrangement is a lease at inception. Operating leases are included in right-of-use assets, operating lease obligations, current, and operating lease obligations, net of current portion, on the Company’s consolidated balance sheets.
Right-of-use assets and lease liabilities are recognized at the lease commencement date based on the present value of future minimum lease payments over the lease term. As the Company’s leases do not provide an implicit rate, the Company uses a discount rate based on its estimated incremental borrowing rate to determine the right-of-use asset and operating lease liabilities to be recognized. The Company determines its incremental borrowing rate based on the terms and lease payments of its operating leases and what it would normally pay to borrow, on a collateralized basis, over similar terms for an amount equal to the lease payments. Operating lease expense is recognized on a straight-line basis over the lease term. In addition, the Company does not separate lease components from non-lease components. The Company has elected to not recognize right-of-use assets and lease liabilities for leases with an initial term of 12 months or less. The Company recognizes lease expense on a straight-line basis over the lease term beginning on the commencement date.
Long-Lived Asset Impairment
The Company reviews long-lived assets for impairment when events or changes in circumstances (“triggering event”) indicate that the carrying value of an asset or group of assets may not be recovered. If a triggering event is determined to have occurred, the carrying value of an asset or group of assets is compared to the future undiscounted cash flows expected to be generated by the asset or group of assets. If the carrying value exceeds the undiscounted cash flows of the asset or group of assets, then an impairment exists, which is measured as the excess of fair value over the asset or asset group’s carrying value. Fair value is generally determined using the asset’s expected future discounted cash flows or market value, if readily determinable.
Revenue Recognition
The following table presents the Company's revenue disaggregated by segment, product, and geography (in thousands, except percentages):
LCT:
|
|
Three Months Ended June 30, 2026 |
|
|
Six Months Ended June 30, 2026 |
|
||||||||||||||||||||||||||
|
|
|
|
|
|
|
|
Total |
|
|
% of Total |
|
|
|
|
|
|
|
|
Total |
|
|
% of Total |
|
||||||||
|
|
Domestic |
|
|
International |
|
|
Revenues |
|
|
Revenues |
|
|
Domestic |
|
|
International |
|
|
Revenues |
|
|
Revenues |
|
||||||||
Biomedical products |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||
Media |
|
$ |
|
|
$ |
|
|
$ |
|
|
|
% |
|
$ |
|
|
$ |
|
|
$ |
|
|
|
% |
||||||||
Cells |
|
|
|
|
|
|
|
|
|
|
|
% |
|
|
|
|
|
|
|
|
|
|
|
% |
||||||||
Total |
|
$ |
|
|
$ |
|
|
$ |
|
|
|
% |
|
$ |
|
|
$ |
|
|
$ |
|
|
|
% |
||||||||
9
|
|
Three Months Ended June 30, 2025 |
|
|
Six Months Ended June 30, 2025 |
|
||||||||||||||||||||||||||
|
|
|
|
|
|
|
|
Total |
|
|
% of Total |
|
|
|
|
|
|
|
|
Total |
|
|
% of Total |
|
||||||||
|
|
Domestic |
|
|
International |
|
|
Revenues |
|
|
Revenues |
|
|
Domestic |
|
|
International |
|
|
Revenues |
|
|
Revenues |
|
||||||||
Biomedical products |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||
Media |
|
$ |
|
|
$ |
|
|
$ |
|
|
|
% |
|
$ |
|
|
$ |
|
|
$ |
|
|
|
% |
||||||||
Cells |
|
|
|
|
|
|
|
|
|
|
|
% |
|
|
|
|
|
|
|
|
|
|
|
% |
||||||||
Total |
|
$ |
|
|
$ |
|
|
$ |
|
|
|
% |
|
$ |
|
|
$ |
|
|
$ |
|
|
|
% |
||||||||
LSC:
|
|
Three Months Ended June 30, |
|
|
Six Months Ended June 30, |
|
||||||||||
|
|
2026 |
|
|
2025 |
|
|
2026 |
|
|
2025 |
|
||||
Skin care products |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
Contract terms for the unit price, quantity, shipping and payment are governed by sales agreements, invoices or online order forms, which the Company considers to be a customer's contract in all cases. The unit price is considered the observable stand-alone selling price for the performance obligation(s) within the arrangements. Any promotional or volume sales discounts are applied evenly to the units sold for purposes of calculating standalone selling price.
The Company recognizes revenue when its customer obtains control of the promised goods or services in an amount that reflects the consideration the entity expects to receive in exchange for those goods or services. Product sales generally consist of a single performance obligation that the Company satisfies at a point in time (i.e., upon shipment of the product).
The standard payment terms for the Company's customers are generally 30 days after the Company satisfies the performance obligation(s). For LSC products, ecommerce sales are primarily paid at the time of purchase.
The Company elects to account for shipping and handling costs, recognized as cost of sales, as activities to fulfill the promise to transfer the goods to a customer. As a result, no consideration is allocated to shipping and handling costs. Rather, the Company accrues the cost of shipping and handling upon shipment of the product, and all contract revenue (i.e., the transaction price) is recognized at the same time.
Variable Consideration
The Company records revenue from customers in an amount that reflects the consideration it expects to be entitled to after transferring control of those goods or services to a customer. From time to time, the Company offers sales promotions on its LSC products, such as discounts and free product offers. Variable consideration is estimated at contract inception only to the extent that it is probable that a significant reversal of revenue will not occur and is updated at the end of each reporting period as additional information becomes available.
Practical Expedients
The Company has elected the practical expedient to not determine whether contracts with customers contain significant financing components. The Company pays commissions on certain sales for its biomedical and anti-aging product markets once the customer payment has been received, which are accrued at the time of sale. The Company generally expenses sales commissions when incurred because the amortization period would be
Allowance for Sales Returns
The Company’s anti-aging products have a
Cost of Sales
Cost of sales consists primarily of salaries and benefits associated with employee efforts expended directly on the production of the Company’s products as well as related direct materials, shipping costs, general laboratory supplies, and an allocation of overhead.
Research and Development Costs
Research and development costs, which are expensed as incurred, primarily consist of salaries and benefits associated with research and development personnel, overhead and occupancy costs, contract services costs, and amortization of license costs for technology used in research and development with alternative future uses, offset by the research and development tax credit provided by the Australian Taxation Office for qualified expenditures.
10
Australian Research and Development Tax Credit
The Company’s wholly owned subsidiary, Cyto Therapeutics, conducts various research and development activities on the Company’s product candidates in Australia. Under Australian tax law, the Australian Taxation Office provides for a refundable tax credit in the form of a cash refund equal to
The refundable tax credit does not depend on the Company’s generation of future taxable income or ongoing tax status or position. Accordingly, the credit is not considered an element of income tax accounting under Financial Accounting Standards Board (the “FASB”) Accounting Standards Codification (“ASC”) 740 – Income Taxes. The Company uses the grant accounting model by analogy to International Accounting Standards ("IAS") 20 – Accounting for Government Grants and Disclosure of Government Assistance to account for the refundable tax credit from the Australian government. The Company recognizes the research and development tax credit as a reduction to research and development expense when there is reasonable assurance that the tax credit will be received, the relevant expenses have been incurred, and the amount can be reliably measured. During the three and six months ended June 30, 2026 and 2025, the Company recognized a reduction in qualified research and development expenses of $
Stock-Based Compensation
The cost of a stock-based award is measured at the grant date based on the estimated fair value of the award. Stock-based compensation is recognized as expense on a straight-line basis, net of forfeitures, which are recognized as incurred, over the requisite service period of the award. The fair value of stock options is estimated using the Black-Scholes option valuation model, which requires the input of subjective assumptions, including price volatility of the underlying stock, risk-free interest rate, dividend yield, and expected life of the option.
Fair Value Measurements
The carrying amounts of the Company’s accounts receivable, accounts payable, and accrued liabilities are considered to be representative of their respective fair values because of the short-term nature of those instruments. The carrying value of the Company's related party note payable does not approximate fair value. Refer to Note 7 – Related Party Transactions for further discussion.
Net Income (Loss) Per Share
Basic net income (loss) per share attributable to common stockholders is calculated by dividing the net income (loss) attributable to common stockholders by the weighted-average number of common shares outstanding during the period. Diluted net income per share attributable to common stockholders is computed by dividing the net income attributable to common stockholders by the weighted-average number of common stock equivalents outstanding for the period determined using the treasury and two-class or “if-converted” method. The two-class method is not applicable during periods with a net loss, as the holders of the convertible preferred stock have no obligation to fund losses. Potentially dilutive common stock equivalents are comprised of stock options and convertible preferred stock.
The following table details the composition of basic and diluted income (loss) per common share as follows ($ in thousands):
|
|
Three Months Ended June 30, |
|
|
Six Months Ended June 30, |
|
||||||||||
|
|
2026 |
|
|
2025 |
|
|
2026 |
|
|
2025 |
|
||||
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
Net income (loss) |
|
$ |
( |
) |
|
$ |
|
|
$ |
( |
) |
|
$ |
( |
) |
|
Less: undistributed earnings allocated to participating securities |
|
|
|
|
|
( |
) |
|
|
— |
|
|
|
— |
|
|
Net income (loss) attributable to common stockholders, basic and diluted |
|
$ |
( |
) |
|
$ |
|
|
$ |
( |
) |
|
$ |
( |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
Weighted-average number of common shares outstanding, basic and diluted |
|
|
|
|
|
|
|
|
|
|
|
|
||||
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
Net income (loss) per share attributable to common stockholders, basic and diluted |
|
$ |
( |
) |
|
$ |
|
|
$ |
( |
) |
|
$ |
( |
) |
|
11
For the three and six months ended June 30, 2026 and 2025, the following common stock options and convertible preferred stock were not included in the diluted net loss per share calculation because the effect would have been anti-dilutive:
|
|
Three Months Ended June 30, |
|
|
Six Months Ended June 30, |
|
||||||||||
|
|
2026 |
|
|
2025 |
|
|
2026 |
|
|
2025 |
|
||||
Employee stock options |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Redeemable convertible preferred stock |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Non-redeemable convertible preferred stock |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Total |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Customer Concentrations
For the three months ended June 30, 2026 and 2025,
For the three and six months ended June 30, 2026 and 2025, no other single customer accounted for more than 10% of revenues in any segment. No other single customer accounted for more than 10% of accounts receivable, net as of June 30, 2026. At December 31, 2025
Cash Concentrations
The Company maintains deposits in federally insured financial institutions in excess of federally insured limits. The Company has not experienced any losses in such accounts, and management believes that the Company is not exposed to significant credit risk due to the financial position of the depository institutions in which those deposits are held.
Recently Issued Accounting Pronouncements
In November 2024, the FASB issued ASU No. 2024-03, Income Statement—Reporting Comprehensive Income—Expense Disaggregation Disclosures (Subtopic 220-40) (“ASU 2024-03”). ASU 2024-03 requires disclosure of disaggregated information about any relevant expense captions presented on the face of the consolidated statement of operations, including the following required natural expense categories: (1) purchases of inventory, (2) employee compensation, (3) depreciation, (4) intangible asset amortization, and (5) depreciation, depletion, and amortization (“DD&A”) recognized as part of oil- and gas-producing activities or other depletion expenses, as well as certain other expenses, when applicable. The new standard will be effective for annual reporting periods beginning after December 15, 2026 and interim periods within fiscal years beginning after December 15, 2027. Early adoption is permitted. The Company is currently evaluating the potential impact that this standard may have on its consolidated financial statements and related disclosures.
2. Inventories
The components of inventories are as follows (in thousands):
|
|
June 30, |
|
|
December 31, |
|
||
|
|
2026 |
|
|
2025 |
|
||
Raw materials |
|
$ |
|
|
$ |
|
||
Work in process |
|
|
|
|
|
|
||
Finished goods |
|
|
|
|
|
|
||
|
|
|
|
|
|
|
||
Less: allowance for inventory excess and obsolescence |
|
|
( |
) |
|
|
( |
) |
Total inventories |
|
$ |
|
|
$ |
|
||
|
|
|
|
|
|
|
||
Inventories |
|
$ |
|
|
$ |
|
||
Non-current inventories |
|
|
|
|
|
|
||
Total inventories |
|
$ |
|
|
$ |
|
||
12
3. Prepaid Expenses and Other Current Assets
The components of prepaid expenses and other current assets are as follows (in thousands):
|
|
June 30, |
|
|
December 31, |
|
||
|
|
2026 |
|
|
2025 |
|
||
Prepaid expenses |
|
$ |
|
|
$ |
|
||
Australian research and development tax credit |
|
|
— |
|
|
|
|
|
Other current assets |
|
|
|
|
|
|
||
Total prepaid expenses and other current assets |
|
$ |
|
|
$ |
|
||
4. Property and Equipment, net
Property and equipment consist of the following (in thousands):
|
|
June 30, |
|
|
December 31, |
|
||
|
|
2026 |
|
|
2025 |
|
||
Machinery and equipment |
|
$ |
|
|
$ |
|
||
Computer equipment and software |
|
|
|
|
|
|
||
Office equipment |
|
|
|
|
|
|
||
Leasehold improvements |
|
|
|
|
|
|
||
Construction in progress |
|
|
|
|
|
|
||
|
|
|
|
|
|
|
||
Less: accumulated depreciation and amortization |
|
|
( |
) |
|
|
( |
) |
Property and equipment, net |
|
$ |
|
|
$ |
|
||
Depreciation and amortization expense for the three months ended June 30, 2026 and 2025 was $
5. Intangible Assets, net
Intangible assets consist of the following (in thousands):
|
|
June 30, |
|
|
December 31, |
|
||
|
|
2026 |
|
|
2025 |
|
||
Patents |
|
$ |
|
|
$ |
|
||
Less: accumulated amortization |
|
|
( |
) |
|
|
( |
) |
|
|
|
|
|
|
|
||
Indefinite life logos and trademarks |
|
|
|
|
|
|
||
Intangible assets, net |
|
$ |
|
|
$ |
|
||
Amortization expense for the three months ended June 30, 2026 and 2025 was $
6. Convertible Preferred Stock and Stockholders’ Deficit
Convertible Preferred Stock
As of June 30, 2026 and December 31, 2025, the Company was authorized to issue
Non-Redeemable Convertible Preferred Stock
The Company’s Series B, Series G, and Series I-2 non-redeemable convertible preferred stock has been classified as equity on the accompanying condensed consolidated balance sheets.
13
The authorized, issued, and outstanding shares of non-redeemable convertible preferred stock as of June 30, 2026 consist of the following:
|
|
|
|
|
Shares |
|
|
|
|
|
|
|
||||
|
|
Shares |
|
|
Issued and |
|
|
Liquidation |
|
|
Carrying |
|
||||
|
|
Authorized |
|
|
Outstanding |
|
|
Preference |
|
|
Value |
|
||||
|
|
|
|
|
|
|
|
(in thousands) |
|
|||||||
Series B |
|
|
|
|
|
|
|
$ |
|
|
$ |
— |
|
|||
Series G |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Series I-2 |
|
|
|
|
|
|
|
|
|
|
|
— |
|
|||
Total |
|
|
|
|
|
|
|
$ |
|
|
$ |
|
||||
The authorized, issued and outstanding shares of non-redeemable convertible preferred stock as of December 31, 2025 consisted of the following:
|
|
|
|
|
Shares |
|
|
|
|
|
|
|
||||
|
|
Shares |
|
|
Issued and |
|
|
Liquidation |
|
|
Carrying |
|
||||
|
|
Authorized |
|
|
Outstanding |
|
|
Preference |
|
|
Value |
|
||||
|
|
|
|
|
|
|
|
(in thousands) |
|
|||||||
Series B |
|
|
|
|
|
|
|
$ |
|
|
$ |
— |
|
|||
Series G |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Series I-2 |
|
|
|
|
|
|
|
|
|
|
|
— |
|
|||
Total |
|
|
|
|
|
|
|
$ |
|
|
$ |
|
||||
Series D Preferred Stock Redemption
The Company’s Series D redeemable convertible preferred stock contains a contingent redemption feature that is not solely within the Company’s control. Accordingly, the Series D redeemable convertible preferred stock is classified in temporary equity (outside of permanent equity) on the accompanying condensed consolidated balance sheets. As of June 30, 2026, Management concluded the contingency is not probable of being resolved. The Company will continue to monitor the probability of the contingency event at each reporting date.
Dividends
Holders of the Company’s convertible preferred stock are entitled to participating dividends with common stock when and if declared by the Company’s Board of Directors. The Series D and G convertible preferred stock previously had rights to cumulative dividends in liquidation whether declared or not declared. Since the holders waived the rights to such dividends in 2012, this does not have an ongoing impact.
Liquidation
Liquidation preference among classes of preferred shares is first with Series D with priority followed by Series G, Series B and Series I-2 on the proceeds from any sale or liquidation of the Company in an amount equal to the purchase price of shares plus (in the case of the Series B) an amount equal to
Conversion
The shares of convertible preferred stock are convertible into shares of common stock at any time, at the option of the holder. The conversion rates of the Series B, Series D, and Series I-2 are subject to anti-dilution adjustments whereby, subject to specified exceptions, if the Company issues equity securities or securities convertible into equity at a price below the applicable conversion price of the Series B, Series D, and Series I-2, the conversion price of each such series shall be adjusted downward to equal the price of the new securities. The conversion rate of the Series G is subject to a weighted-average adjustment in the event of the issuance of additional shares of common stock below the conversion price, subject to specified exceptions. The conversion price of the Series I-2 is also subject to certain resets as set forth in the Certificates of Designation, including a reverse stock split.
The following table summarizes the conversion ratio of shares of common stock into which each share of convertible preferred stock can be converted as of June 30, 2026:
|
|
|
|
|
|
|
|
Conversion |
|
|||
|
|
Initial |
|
|
Current |
|
|
Ratio to |
|
|||
|
|
Conversion |
|
|
Conversion |
|
|
Common |
|
|||
|
|
Price |
|
|
Price |
|
|
Stock |
|
|||
Series B |
|
$ |
|
|
$ |
|
|
|
|
|||
Series D |
|
$ |
|
|
$ |
|
|
|
|
|||
Series G |
|
$ |
|
|
$ |
|
|
|
|
|||
Series I-2 |
|
$ |
|
|
$ |
|
|
|
|
|||
14
Voting
Common Stock
As of June 30, 2026 and December 31, 2025, the Company was authorized to issue
Equity Incentive Plans
The Company adopted the 2010 Equity Participation Plan, as amended (the “2010 Plan”), which provides for the grant of stock options, restricted stock, and other equity-based awards. Awards for up to
In June 2020, the Company amended the 2010 Plan to extend the term of the 2010 Plan until
In September 2023, the Company's Board of Directors voted to amend the 2010 Plan (“2010 Plan Amendment”) to 1) increase the number of shares that may be issued under the 2010 Plan from
For the three and six months ended June 30, 2026, there were
Stock Options
The Company's stock option activity, involving stock options issued to employees, directors, and consultants under the 2010 Plan, for the six months ended June 30, 2026 is summarized below:
|
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Average |
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||||
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|
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Weighted- |
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Remaining |
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Aggregate |
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||||
|
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Number of |
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|
Average |
|
|
Contractual |
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|
Intrinsic |
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||||
|
|
Outstanding |
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Exercise |
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Term |
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Value |
|
||||
|
|
Options |
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|
Price |
|
|
(in years) |
|
|
(in thousands) |
|
||||
Outstanding at December 31, 2025 |
|
|
|
|
$ |
|
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|
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|
||||
Granted |
|
|
|
|
$ |
|
|
|
|
|
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|
||||
Expired |
|
|
( |
) |
|
$ |
|
|
|
|
|
|
|
|||
Outstanding at June 30, 2026 |
|
|
|
|
$ |
|
|
|
|
|
$ |
|
||||
Vested and expected to vest at June 30, 2026 |
|
|
|
|
$ |
|
|
|
|
|
$ |
|
||||
Exercisable at June 30, 2026 |
|
|
|
|
$ |
|
|
|
|
|
$ |
|
||||
The fair value of stock options granted is estimated at the date of grant using the Black-Scholes option valuation model.
|
Three and Six Months Ended June 30, |
||
|
2026 |
|
2025 |
Risk-free interest rate |
|
||
Expected stock price volatility |
|
||
Expected dividend yield |
|
||
Expected life of options (in years) |
|
||
Weighted-average grant date fair value |
$ |
|
$ |
15
Total stock-based compensation expense recorded in the condensed consolidated statements of operations is as follows (in thousands):
|
|
Three Months Ended June 30, |
|
|
Six Months Ended June 30, |
|
||||||||||
|
|
2026 |
|
|
2025 |
|
|
2026 |
|
|
2025 |
|
||||
General and administrative |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
Research and development |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Total |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
Unrecognized compensation expense related to stock options as of June 30, 2026 was $
Common Stock Reserved for Future Issuance
As of June 30, 2026, the Company had shares of common stock reserved for future issuance as follows:
Options outstanding |
|
|
|
|
Common stock available for issuance under the 2010 Plan |
|
|
|
|
Redeemable convertible preferred stock |
|
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|
|
Non-redeemable convertible preferred stock |
|
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|
|
Total |
|
|
|
7. Related Party Transactions
Related party lease arrangements
On October 26, 2021, the Company and S Real Estate Holdings LLC jointly entered into a lease agreement with Rehco Holdings, LLC (the “Lease”), for the purpose of establishing a new corporate headquarters, including corporate, R&D, and manufacturing operations. The Lease was personally guaranteed by Dr. Russell Kern, the Company’s Executive Vice President and Chief Scientific Officer.
On December 15, 2021, the Company and S Real Estate Holdings LLC entered into a co-tenant agreement, whereby the Company and S Real Estate Holdings LLC agreed to allocate portions of the base rent and variable charges, including insurance, maintenance costs, taxes, and operating expenses, between the parties. During the term of the Lease, the Company was liable for
Refer to Note 8 – Commitments and Contingencies for further discussion.
Related party note payable
Between March 2018 and September 2022, to obtain funding for working capital purposes, the Company borrowed a total of $
During 2023, the Note was amended several times, with the final amendment resulting in the issuance of the new promissory note in September 2023 ("September 2023 Note") with a maturity date of
In September 2024, the Company surrendered its September 2023 Note and entered into a new agreement (“September 2024 Note”), which included repaying $
16
In June 2025, the Company repaid $
8. Commitments and Contingencies
Leases
The Company has
In October 2021, the Company entered into an operating lease for its new corporate headquarters. The lease commenced in November 2021 and expires on
In November 2021, the Company entered into an operating lease for supplemental office space adjacent to its new corporate headquarters with the same landlord. The lease commenced in December 2021 and expires on
In February 2025, the Company and S Real Estate Holdings, LLC, a related party, amended its co-tenant agreement to re-allocate portions of the base rent and variable charges. Retroactively, as of January 2025, the Company became liable for
In March 2025, the Company and St. John Properties, Inc, amended its lease agreement to extend the lease expiration for
The Company’s operating leases for real estate are subject to additional variable charges for common area maintenance and other variable costs. Variable costs for the three and six months ended June 30, 2026 and 2025 were immaterial. All operating lease expense is recognized on a straight-line basis over the lease term. For the three months ended June 30, 2026 and 2025, lease expense totaled $
17
Maturities of lease liabilities are as follows (in thousands):
Years ending December 31, |
|
|
|
|
2026 (remaining six months) |
|
$ |
|
|
Total minimum lease payments |
|
|
|
|
Less: imputed interest |
|
|
( |
) |
Total future minimum lease payments |
|
|
|
|
Less: operating lease liabilities, current |
|
|
( |
) |
Operating lease liabilities, net of current portion |
|
$ |
|
|
9. Segments
The Company operates the business on the basis of
The Company does not measure the performance of its segments on any asset-based metrics. Therefore, segment information is presented only for the results of operations.
|
|
Three Months Ended June 30, 2026 |
|
|||||||||||||
|
|
ISCO |
|
|
LCT |
|
|
LSC |
|
|
Total |
|
||||
|
$ |
— |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Cost of sales |
|
|
— |
|
|
|
|
|
|
|
|
|
|
|||
General and administrative |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Selling and marketing |
|
|
— |
|
|
|
|
|
|
|
|
|
|
|||
Research and development |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Total operating expenses |
|
|
|
|
|
|
|
|
|
|
|
|
||||
(Loss) income from operations |
|
$ |
( |
) |
|
$ |
|
|
$ |
( |
) |
|
$ |
( |
) |
|
Total other expense, net |
|
|
|
|
|
|
|
|
|
|
|
( |
) |
|||
Net loss |
|
|
|
|
|
|
|
|
|
|
$ |
( |
) |
|||
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
Additional Segment Information |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Interest expense (1) |
|
$ |
( |
) |
|
$ |
— |
|
|
$ |
— |
|
|
$ |
( |
) |
Depreciation and amortization |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
Share-based compensation expense |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
(1) Includes interest expense and interest expense - related party. |
|
|
|
|
|
|
|
|
|
|
|
|
||||
18
|
|
Three Months Ended June 30, 2025 |
|
|||||||||||||
|
|
ISCO |
|
|
LCT |
|
|
LSC |
|
|
Total |
|
||||
|
$ |
— |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Cost of sales |
|
|
— |
|
|
|
|
|
|
( |
) |
|
|
|
||
General and administrative |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Selling and marketing |
|
|
— |
|
|
|
|
|
|
|
|
|
|
|||
Research and development |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Total operating expenses |
|
|
|
|
|
|
|
|
|
|
|
|
||||
(Loss) income from operations |
|
$ |
( |
) |
|
$ |
|
|
$ |
( |
) |
|
$ |
|
||
Total other expense, net |
|
|
|
|
|
|
|
|
|
|
|
( |
) |
|||
Net income |
|
|
|
|
|
|
|
|
|
|
$ |
|
||||
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
Additional Segment Information |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Interest expense (1) |
|
$ |
( |
) |
|
$ |
— |
|
|
$ |
— |
|
|
$ |
( |
) |
Depreciation and amortization |
|
$ |
|
|
$ |
|
|
$ |
— |
|
|
$ |
|
|||
Share-based compensation expense |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
(1) Includes interest expense and interest expense - related party. |
|
|
|
|
|
|
|
|
|
|
|
|
||||
|
|
Six Months Ended June 30, 2026 |
|
|||||||||||||
|
|
ISCO |
|
|
LCT |
|
|
LSC |
|
|
Total |
|
||||
|
$ |
— |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Cost of sales |
|
|
— |
|
|
|
|
|
|
|
|
|
|
|||
General and administrative |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Selling and marketing |
|
|
— |
|
|
|
|
|
|
|
|
|
|
|||
Research and development |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Total operating expenses |
|
|
|
|
|
|
|
|
|
|
|
|
||||
(Loss) income from operations |
|
$ |
( |
) |
|
$ |
|
|
$ |
( |
) |
|
$ |
( |
) |
|
Total other expense, net |
|
|
|
|
|
|
|
|
|
|
|
( |
) |
|||
Net loss |
|
|
|
|
|
|
|
|
|
|
$ |
( |
) |
|||
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
Additional Segment Information |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Interest expense (1) |
|
$ |
( |
) |
|
$ |
— |
|
|
$ |
— |
|
|
$ |
( |
) |
Depreciation and amortization |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
Share-based compensation expense |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
(1) Includes interest expense and interest expense - related party. |
|
|
|
|
|
|
|
|
|
|
|
|
||||
19
|
|
Six Months Ended June 30, 2025 |
|
|||||||||||||
|
|
ISCO |
|
|
LCT |
|
|
LSC |
|
|
Total |
|
||||
|
$ |
— |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Cost of sales |
|
|
— |
|
|
|
|
|
|
|
|
|
|
|||
General and administrative |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Selling and marketing |
|
|
— |
|
|
|
|
|
|
|
|
|
|
|||
Research and development |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Total operating expenses |
|
|
|
|
|
|
|
|
|
|
|
|
||||
(Loss) income from operations |
|
$ |
( |
) |
|
$ |
|
|
$ |
( |
) |
|
$ |
( |
) |
|
Total other expense, net |
|
|
|
|
|
|
|
|
|
|
|
( |
) |
|||
Net loss |
|
|
|
|
|
|
|
|
|
|
$ |
( |
) |
|||
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
Additional Segment Information |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Interest expense (1) |
|
$ |
( |
) |
|
$ |
— |
|
|
$ |
— |
|
|
$ |
( |
) |
Depreciation and amortization |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
Share-based compensation expense |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
(1) Includes interest expense and interest expense - related party. |
|
|
|
|
|
|
|
|
|
|
|
|
||||
10. Subsequent Events
On July 10, 2026, the Company entered into a Membership Interest Purchase Agreement (the "MIPA") with American Type Culture Collection, Inc. ("ATCC"), pursuant to which the Company agreed to sell 100% of the membership interests of Lifeline Cell Technology, LLC ("LCT"), its subsidiary engaged in the development, manufacture, and sale of biological materials and reagents for scientific research, to ATCC (the "Transaction").
The aggregate purchase price is $25.0 million, subject to adjustment for estimated net working capital, closing date cash and closing date indebtedness. At closing, ATCC will pay the adjusted purchase price in cash, less a $2.6 million escrow deposit, subject to a post-closing true-up process.
20
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations
The following discussion of our financial condition and results of operations should be read in conjunction with our unaudited condensed consolidated financial statements and related notes and other financial information included elsewhere herein. This information should also be read in conjunction with our audited historical consolidated financial statements which are included in our Form 10-K for the fiscal year ended December 31, 2025 (“Form 10-K”). The discussion contains forward-looking statements, such as our plans, expectations and intentions (including those related to clinical trials and business and expense trends), that are based upon current expectations and that involve risks and uncertainties. Our actual results may differ significantly from management’s expectations. The factors that could affect these forward-looking statements are discussed in the Risk Factors included in our Form 10-K. This discussion should not be construed to imply that the results discussed herein will necessarily continue into the future, or that any expectations expressed herein will necessarily be indicative of actual operating results in the future. Such discussion represents only the best assessment by our management.
Business Overview
We are a clinical stage biotechnology company focused on therapeutic product development with two revenue-generating businesses offering potential for increased future revenue. We have generated aggregate product revenues from our two commercial businesses of $2.7 million and $2.4 million for the three months ended June 30, 2026 and 2025, respectively, and $5.0 million and $4.6 million for the six months ended June 30, 2026 and 2025, respectively. We currently have no revenue generated from our principal operations in therapeutic product development.
Our products are based on multi-decade experience with human cell culture and a proprietary type of pluripotent stem cells, human parthenogenetic stem cells (“hpSCs”). Our hpSCs are comparable to human embryonic stem cells (“hESCs”) in that they have the potential to be differentiated into many different cells in the human body. However, the derivation of hpSCs does not require the use of fertilized eggs or the destruction of viable human embryos and also offers the potential for the creation of immune-matched cells and tissues that are less likely to be rejected following transplantation. Our collection of hpSCs, known as UniStemCell™, currently consists of 15 stem cell lines. We have manufacturing protocols that comply with the requirements of Good Manufacturing Practice (GMP) standards as promulgated by the U.S. Code of Federal Regulations and enforced by the United States Food and Drug Administration (“FDA”).
Market Opportunity and Growth Strategy
Therapeutic Market – Clinical Applications of hpSCs for Disease Treatments
We are developing different cell types from our stem cells that may result in therapeutic products. We focus on applications where cell and tissue therapy is already proven but where there is an insufficient supply of functional cells or tissue.
We believe that the most promising potential clinical applications of our technology are Parkinson’s disease (“PD”), traumatic brain injury (“TBI”), and stroke. Using our proprietary technologies and know-how, we are creating neural stem cells from hpSCs as a potential treatment of PD, TBI, and stroke.
PD: Our most advanced project is the neural stem cell program for the treatment of Parkinson’s disease. In 2013, we published in Nature Scientific Reports the basis for our patent on a new method of manufacturing neural stem cells, which is used to produce the clinical-grade cells necessary for future clinical studies and commercialization. In 2014, we completed the majority of the preclinical research, establishing the safety profile of NSC in various animal species, including non-human primates. In June 2016, we published the results of a 12-month preclinical non-human primate study, which demonstrated the safety, efficacy, and mechanism of action of the ISC- hpNSC®. In 2017, we dosed four patients in our Phase I trial of ISC-hpNSC®, human parthenogenetic stem cell-derived neural stem cells for the treatment of Parkinson’s disease. We reported 12-month results from the first cohort and 6-month interim results of the second cohort at the Society for Neuroscience annual meeting (Neuroscience 2018) in November 2018. In April 2019, we announced the completion of subject enrollment, with the 12th subject receiving a transplantation of the highest dose of cells. There have been no safety signals or serious adverse effects seen to date as related to the transplanted ISC-hpNSC® cells.
We announced the successful completion of the dose escalating phase 1 clinical trial in June 2021. In terms of preliminary efficacy, where scores are compared against baseline before transplantation, we observed a potential dose-dependent response with an apparent peak effectiveness at our middle dose. The % OFF-Time, which is the time during the day when levodopa medication is not performing optimally and PD symptoms return, decreased an average 47% from the baseline at 12 months post transplantation in cohort 2. This trend continued through 24 months where the % OFF-Time in the second cohort dropped by 55% from the initial reading. The same was true for % ON-Time without dyskinesia, which is the time during the day when levodopa medication is performing optimally without dyskinesia. The % ON-Time increased an average of 42% above the initial evaluation at 12 months post-transplantation in the second cohort.
Stroke: In August 2014, we announced the launch of a stroke program, evaluating the use of ISC-hpNSC® transplantation for the treatment of ischemic stroke using a rodent model of the disease. The Company has a considerable amount of safety data on ISC-hpNSC® from the Parkinson’s disease program and, as there is evidence that transplantation of ISC-hpNSC® may improve patient
21
outcomes as an adjunctive therapeutic strategy in stroke, having a second program that can use this safety dataset is therefore a logical extension. In 2015, the Company together with Tulane University demonstrated that NSC can significantly reduce neurological dysfunction after a stroke in animal models.
TBI: In October 2016, we announced the results of the preclinical rodent study, evaluating the use of ISC-hpNSC® transplantation for the treatment of TBI. The study was conducted at the University of South Florida Morsani College of Medicine. We demonstrated that animals receiving injections of ISC-hpNSC® displayed the highest levels of improvements in cognitive performance and motor coordination compared to vehicle control treated animals. In February 2019, we published the results of the preclinical study in Theranostics, a prestigious peer-reviewed medical journal. The publication titled, “Human parthenogenetic neural stem cell grafts promote multiple regenerative processes in a traumatic brain injury model,” demonstrated that the clinical-grade neural stem cells used in our Parkinson’s disease clinical trial, ISC-hpNSC®, significantly improved TBI-associated motor, neurological, and cognitive deficits without any safety issues.
Anti-Aging Cosmetic Market – Skin Care Products
Our wholly owned subsidiary Lifeline Skin Care, Inc. (“LSC”) develops, manufactures, and sells skin care products based on two core technologies: encapsulated peptides derived from hpSC and specially discovered small molecules. LSC’s products include:
LSC’s products are regulated as cosmetics. LSC’s products are sold domestically through a branded website and ecommerce partners.
Biomedical Market – Primary Human Cell Research Products
Our wholly owned subsidiary Lifeline Cell Technology, LLC (“LCT”) develops, manufactures, and commercializes approximately 200 human cell culture products, including human primary cells and media, which are needed to grow, maintain, and differentiate the cells. LCT’s scientists have used a standardized, methodical, scientific approach to basal medium optimization to systematically produce optimized products designed to culture specific human cell types and to elicit specific cellular behaviors. These techniques can also be used to produce products that do not contain non-human animal proteins, a feature desirable to the research and therapeutic markets. Each LCT cell product is quality tested for the expression of specific markers (to assure the cells are the correct type), proliferation rate, viability, morphology, and absence of pathogens. Each cell system also contains associated donor information and all informed consent requirements are strictly followed. LCT’s research products are marketed and sold by its internal sales force, OEM partners, and LCT brand distributors in Europe and Asia.
22
Results of Operations
Comparison of the Three Months Ended June 30, 2026 and 2025
The following table summarizes our results of operations for the three months ended June 30, 2026 and 2025 (in thousands, except percentages):
|
|
Three Months Ended June 30, |
|
|||||||||||||
|
|
2026 |
|
|
2025 |
|
|
$ Change |
|
|
% Change |
|
||||
Product sales |
|
$ |
2,675 |
|
|
$ |
2,447 |
|
|
$ |
228 |
|
|
|
9 |
% |
Cost of sales |
|
|
1,217 |
|
|
|
927 |
|
|
|
290 |
|
|
|
31 |
% |
Profit margin |
|
|
1,458 |
|
|
|
1,520 |
|
|
|
(62 |
) |
|
|
-4 |
% |
As a % of revenues |
|
|
55 |
% |
|
|
62 |
% |
|
|
|
|
|
|
||
General and administrative |
|
|
1,062 |
|
|
|
905 |
|
|
|
157 |
|
|
|
17 |
% |
Selling and marketing |
|
|
276 |
|
|
|
286 |
|
|
|
(10 |
) |
|
|
-3 |
% |
Research and development |
|
|
155 |
|
|
|
162 |
|
|
|
(7 |
) |
|
|
-4 |
% |
Other expense |
|
|
(36 |
) |
|
|
(38 |
) |
|
|
2 |
|
|
|
-5 |
% |
Net (loss) income |
|
$ |
(71 |
) |
|
$ |
129 |
|
|
$ |
(200 |
) |
|
|
-155 |
% |
As a % of revenues |
|
|
-3 |
% |
|
|
5 |
% |
|
|
|
|
|
|
||
Product sales, net
Product sales for the three months ended June 30, 2026 were $2,675 thousand compared to $2,447 thousand for the three months ended June 30, 2025. This increase was driven by an increase in product sales from our biomedical market segment, including an increase of $410 thousand from our media product sales partially offset by a decrease in cells and other product sales of $189 thousand. The net increase in product sales from our biomedical market segment was augmented by a small increase in product sales from our skin care product line of approximately $7 thousand.
Cost of sales
Cost of sales for the three months ended June 30, 2026 were $1,217 thousand, compared to $927 thousand for the three months ended June 30, 2025. The increase of $290 thousand, or 31%, was primarily attributable to an increase of approximately $258 thousand in cost of sales from our biomedical market segment driven by an increase in product sales, combined with approximately $7 thousand net increase in manufacturing variances partially offset by decreased shipping costs. In addition, our skin care line saw a net increase of approximately $31 thousand in cost of sales. For the three months ended June 30, 2025, the LSC segment reported negative cost of sales of $1 thousand. This was primarily due to a $43 thousand decrease in inventory reserves, which exceeded other cost of sales components totaling $42 thousand. For the three months ended June 30, 2026, these inventory adjustments were only $13 thousand. The other cost of sales components were primarily related to costs of items sold and shipping.
Profit margins as a percentage of revenue have decreased approximately 7% for the three months ended June 30, 2026, as compared to the three months ended June 30, 2025. The net decrease in gross margins was a result of the normalization in profit margins related to our skin care market segment as compared to prior year. In addition, our biomedical market segment saw a decrease in gross margin of approximately 7% as a result of a change in the sales mix.
Cost of sales consists primarily of salaries and benefits associated with employee efforts expended directly on the production of the Company’s products, as well as related direct materials, general laboratory supplies and the allocation of overhead.
General and administrative expenses
General and administrative expenses for the three months ended June 30, 2026 were $1,062 thousand, compared to $905 thousand for the three months ended June 30, 2025. The increase of $157 thousand, or 17%, was primarily attributable to an increase in legal and consulting costs of approximately $159 thousand related to strategic activities (refer to Note 10 – Subsequent Events for further discussion) combined with an impairment charge of $111 thousand related to certain abandoned patents. These increases were partially offset by a decrease of approximately $36 thousand in insurance and filing fees, $63 thousand in audit and accounting costs, $6 thousand in personnel related costs, $4 thousand in depreciation and amortization, and $5 thousand in foreign currency adjustments.
Our general and administrative expenses consist primarily of employee-related expenses including salaries, bonuses, benefits, and stock-based compensation. Other significant costs include facility costs not otherwise included in or allocated to other departments, legal fees not relating to patents and corporate matters, and fees for accounting and consulting services.
Selling and marketing expenses
Selling and marketing expenses for the three months ended June 30, 2026 were $276 thousand, compared to $286 thousand for the three months ended June 30, 2025. The decrease of $10 thousand, or 3%, was primarily attributable to a decrease of approximately $20 thousand in personnel and consulting related costs partially offset by increases in bank fees of $4 thousand, dues and subscriptions and licenses of $3 thousand and website and advertising expense of $1 thousand.
23
Our selling and marketing expenses consist primarily of employee-related expenses including salaries, bonuses, benefits, and stock-based compensation for our biomedical and anti-aging cosmetic businesses. Other significant costs include facility costs not otherwise included in or allocated to other departments, as well as marketing material costs, permits and licenses for ecommerce, and other advertising expenses.
Research and development expenses
Research and development expenses for the three months ended June 30, 2026 were $155 thousand, compared to $162 thousand for the three months ended June 30, 2025. The decrease of $7 thousand, or 4%, was primarily a result of a decrease of $28 thousand in consulting expenses, $32 thousand in personnel-related costs, and $4 thousand in material and supplies. These decreases were partially offset by a $52 thousand decrease in the Australian research and development tax credit and an increase in costs being paid for rent, lab expenses, and cell storage costs of approximately $4 thousand.
Our research and development efforts are primarily focused on the development of treatments for Parkinson’s disease, traumatic brain injury, and stroke. These projects are long-term investments that involve developing both new stem cell lines and new differentiation techniques that can provide higher purity populations of functional cells. Research and development expenses are expensed as incurred and are accounted for on a project-by-project basis. However, much of our research has potential applicability to each of our projects.
Other expense, net
Other expense for the three months ended June 30, 2026 and 2025 was $36 thousand and $38 thousand, respectively. Other expenses in both periods primarily relate to interest expense on our related party note payable. This decreased as a result of the paydown on principal in 2026.
Comparison of the Six Months Ended June 30, 2026 and 2025
The following table summarizes our results of operations for the six months ended June 30, 2026 and 2025 (in thousands, except percentages):
|
|
Six Months Ended June 30, |
|
|||||||||||||
|
|
2026 |
|
|
2025 |
|
|
$ Change |
|
|
% Change |
|
||||
Product sales |
|
$ |
4,990 |
|
|
$ |
4,576 |
|
|
$ |
414 |
|
|
|
9 |
% |
Cost of sales |
|
|
2,171 |
|
|
|
1,919 |
|
|
|
252 |
|
|
|
13 |
% |
Profit margin |
|
|
2,819 |
|
|
|
2,657 |
|
|
|
162 |
|
|
|
6 |
% |
As a % of revenues |
|
|
56 |
% |
|
|
58 |
% |
|
|
|
|
|
|
||
General and administrative |
|
|
2,184 |
|
|
|
1,797 |
|
|
|
387 |
|
|
|
22 |
% |
Selling and marketing |
|
|
549 |
|
|
|
559 |
|
|
|
(10 |
) |
|
|
-2 |
% |
Research and development |
|
|
311 |
|
|
|
349 |
|
|
|
(38 |
) |
|
|
-11 |
% |
Other expense |
|
|
(66 |
) |
|
|
(79 |
) |
|
|
13 |
|
|
|
-16 |
% |
Net (loss) income |
|
$ |
(291 |
) |
|
$ |
(127 |
) |
|
$ |
(164 |
) |
|
|
129 |
% |
As a % of revenues |
|
|
-6 |
% |
|
|
-3 |
% |
|
|
|
|
|
|
||
Product sales, net
Product sales for the six months ended June 30, 2026 were $4,990 thousand compared to $4,576 thousand for the six months ended June 30, 2025. This increase was driven by an increase in product sales from our biomedical market segment, including an increase of $445 thousand from our media product sales partially offset by a decrease in cells and other product sales of $49 thousand. The net increase in product sales from our biomedical market segment was augmented by a small increase in product sales from our skin care product line of approximately $18 thousand.
Cost of sales
Cost of sales for the six months ended June 30, 2026 were $2,171 thousand, compared to $1,919 thousand for the six months ended June 30, 2025. The increase of $252 thousand, or 13%, was due to an overall increase in product sales from our biomedical market segment slightly offset by a decrease in costs of sales in our skin care line despite the slight increase in sales for the period driven primarily by decreased inventory charges year over year.
Profit margins as a percentage of revenue have decreased approximately 2% for the six months ended June 30, 2026, as compared to the six months ended June 30, 2025. The net decrease in gross margins was as a result of an approximately 3% decrease from our biomedical market segment as a result of a change in the sales mix slightly offset by an increase in profit margins related to our skin care market segment due to less reserve and inventory adjustments.
24
Cost of sales consists primarily of salaries and benefits associated with employee efforts expended directly on the production of the Company’s products, as well as related direct materials, general laboratory supplies, and the allocation of overhead.
General and administrative expenses
General and administrative expenses for the six months ended June 30, 2026 were $2,184 thousand, compared to $1,797 thousand for the six months ended June 30, 2025. The increase of $387 thousand, or 22%, was primarily attributable to increases in legal and consulting costs of approximately $384 thousand related to strategic activities (refer to Note 10 – Subsequent Events for further discussion) and $111 thousand related to the write off of certain abandoned patents. These increases were offset by decreases in audit and accounting fees of approximately $44 thousand, D&O insurance and filing fees of $59 thousand, foreign currency adjustments of $4 thousand, and personnel-related costs of $7 thousand.
Our general and administrative expenses consist primarily of employee-related expenses including salaries, bonuses, benefits, and stock-based compensation. Other significant costs include facility costs not otherwise included in or allocated to other departments, legal fees not relating to patents and corporate matters, and fees for accounting and consulting services.
Selling and marketing expenses
Selling and marketing expenses for the six months ended June 30, 2026 were $549 thousand, compared to $559 thousand for the six months ended June 30, 2025. The decrease of $10 thousand, or 2%, was primarily attributable to a decrease in temporary services of approximately $11 thousand and $6 thousand in consulting costs. These decreases were partially offset by a $6 thousand increase in bank fees.
Our selling and marketing expenses consist primarily of employee-related expenses including salaries, bonuses, benefits, and stock-based compensation for our biomedical and anti-aging cosmetic businesses. Other significant costs include facility costs not otherwise included in or allocated to other departments, as well as marketing material costs, permits and licenses for ecommerce, and other advertising expenses.
Research and development expenses
Research and development expenses for the six months ended June 30, 2026 were $311 thousand, compared to $349 thousand for the six months ended June 30, 2025. The decrease of $38 thousand, or 11%, was a result of a decrease of $60 thousand in consulting fees combined with a $36 thousand decrease in personnel-related costs. These decreases were partially offset by increases in rent, general lab expenses, and cell storage fees of approximately $5 thousand combined with a change in the Australian research and development credit of $52 thousand.
Our research and development efforts are primarily focused on the development of treatments for Parkinson’s disease, traumatic brain injury, and stroke. These projects are long-term investments that involve developing both new stem cell lines and new differentiation techniques that can provide higher purity populations of functional cells. Research and development expenses are expensed as incurred and are accounted for on a project-by-project basis. However, much of our research has potential applicability to each of our projects.
Other expense, net
Other expense for the six months ended June 30, 2026 and 2025 was $66 thousand and $79 thousand, respectively. Other expenses in both periods primarily relate to interest expense on our related party note payable. This decrease is as a result of the principal pay down of $150 thousand on our related party note payable in February 2026 and $200 thousand in June of 2025.
Liquidity and Capital Resources
The Company enters into contracts in the normal course of business with various third-party consultants and contract research organizations (“CRO”) for preclinical research, clinical trials, and manufacturing activities. These contracts generally provide for termination upon notice. Actual expenses associated with these arrangements may be higher or lower due to various reasons, including but not limited to, progress of our development products and enrollment in clinical trials. Other short-term and long terms commitments that would affect liquidity include lease obligations as well as related party debt repayments.
As of June 30, 2026, we had an accumulated deficit of approximately $111.4 million and have historically incurred net losses and negative operating cash flows. Substantially all of our operating losses have resulted from the funding of our research and development programs and general and administrative expenses associated with our operations. We incurred net losses of $291 thousand and $127 thousand for the six months ended June 30, 2026 and 2025, respectively. As of June 30, 2026, we had cash of approximately $1.1 million, compared to $1.0 million as of December 31, 2025. Our primary use of cash is to continue to fund our research and development programs, while maintaining and growing our revenue generating businesses.
25
Cash Flows
Comparison of the Six Months Ended June 30, 2026 and 2025
The following table provides information regarding our cash flows for the six months ended June 30, 2026 and 2025 (in thousands):
|
|
Six Months Ended June 30, |
|
|||||
|
|
2026 |
|
|
2025 |
|
||
Net cash provided by (used in) operating activities |
|
$ |
288 |
|
|
$ |
(73 |
) |
Net cash used in investing activities |
|
|
(42 |
) |
|
|
(37 |
) |
Net cash used in financing activities |
|
|
(150 |
) |
|
|
(200 |
) |
Net increase (decrease) in cash |
|
$ |
96 |
|
|
$ |
(310 |
) |
Operating Cash Flows
For the six months ended June 30, 2026, net cash provided by operating activities was $288 thousand, resulting primarily from our net loss of $291 thousand and net changes in operating assets and liabilities of $26 thousand, consisting of increases in accounts payable of $142 thousand and accrued liabilities of $541 thousand. These increases were offset by an increase in accounts receivable of $236 thousand, inventories of $221 thousand, prepaid expenses and other current assets of $6 thousand and a decrease in operating lease liabilities of $194 thousand. In addition, there was a $553 thousand increase pertaining to non-cash adjustments consisting of recurring non-cash expenses, such as stock-based compensation, depreciation and amortization expense, non-cash operating lease expense, changes in inventory reserve and interest expense on our related party note payable.
For the six months ended June 30, 2025, net cash used in operating activities was $73 thousand, attributable to our net loss of $127 thousand and net changes in operating assets and liabilities of $496 thousand, offset by net recurring non-cash adjustments of $550 thousand.
Investing Cash Flows
Net cash used in investing activities for the six months ended June 30, 2026 was $42 thousand, compared to $37 thousand for the six months ended June 30, 2025. The increase was attributable to payments for patent licenses slightly offset by less purchases of property and equipment during the current period.
Financing Cash Flows
Net cash used in financing activities for the six months ended June 30, 2026 was $150 thousand, compared to $200 thousand for the six months ended June 30, 2025. The decrease was attributable to the paydown on the related party note in February 2026 versus June 2025.
Funding Requirements
Management continues to evaluate various financing sources and options to raise working capital to help fund our current research and development programs and operations. We will need to obtain significant additional capital from equity and/or debt financings, license arrangements, grants and/or collaborative research arrangements to sustain our operations and develop products. Unless we obtain additional financing, we do not have sufficient cash on hand to sustain our operations at least through one year after the issuance date. The timing and degree of any future capital requirements will depend on many factors, including:
Our failure to raise capital or enter into applicable arrangements when needed would have a negative impact on our financial condition. Additional debt financing may be expensive and require us to pledge all or a substantial portion of its assets. Further, if additional funds are obtained through arrangements with collaborative partners, these arrangements may require us to relinquish rights
26
to some of our technologies, product candidates, or products that we would otherwise seek to develop and commercialize on our own. If sufficient capital is not available, we may be required to delay, reduce the scope of, or eliminate one or more of our product initiatives.
We currently have no revenue generated from our principal operations in therapeutic product development through research and development efforts. There can be no assurance that we will be successful in maintaining our normal operating cash flow and obtaining additional funds and that the timing of our capital raising or future financing will result in cash flow sufficient to sustain our operations at least through one year after the issuance date.
Based on the factors above, there is substantial doubt about our ability to continue as a going concern. The consolidated financial statements were prepared assuming that we will continue to operate as a going concern. The consolidated financial statements do not include any adjustments to reflect the possible future effects on the recoverability and classification of assets or the amounts and classification of liabilities that may result from the outcome of this uncertainty. Management’s plans in regard to these matters are focused on managing our cash flow, the proper timing of our capital expenditures, and raising additional capital or financing in the future.
Critical Accounting Estimates
Our management’s discussion and analysis of our financial condition and results of operations are based on our condensed consolidated financial statements, which have been prepared in accordance with generally accepted accounting principles in the United States of America and the rules and regulations of the Securities and Exchange Commission. The preparation of these condensed consolidated financial statements requires us to make judgments and estimates that affect the reported amounts of assets and liabilities, the disclosure of contingent assets and liabilities at the date of the condensed consolidated financial statements, and the reported amounts of revenues, costs, and expenses during the reporting periods.
Our estimates are based on our historical experience, known trends and events, and on various other factors that we believe are reasonable under the circumstances, the results of which form the basis for making judgments about the carrying value of assets and liabilities and amount of expense recognized that are not readily apparent from other sources. Actual results may differ from these estimates under different assumptions or conditions. We evaluate our estimates and assumptions on an ongoing basis. The effects of material revisions in estimates, if any, will be reflected in the condensed consolidated financial statements prospectively from the date of the change in estimates.
There have been no material changes to our critical accounting policies and estimates during the six months ended June 30, 2026 from those disclosed in “Part II – Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations” included in our Annual Report on Form 10-K.
Recently Issued Accounting Pronouncements
A description of recently issued accounting pronouncements that may potentially impact our financial position and results of operations is disclosed in Note 1 – Description of Business, Basis of Presentation, and Summary of Significant Accounting Policies to our condensed consolidated financial statements of this Quarterly Report on Form 10-Q.
Contractual Obligations and Commitments
There have been no material changes to our contractual obligations and commitments outside the ordinary course of business during the six months ended June 30, 2026 from those disclosed in “Part II – Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations” included in our Annual Report on Form 10-K.
Item 3. Quantitative and Qualitative Disclosures About Market Risk
We are a smaller reporting company, as defined by Rule 12b-2 of the Exchange Act, and are not required to provide the information required under this item.
Item 4. Controls and Procedures
Disclosure Controls and Procedures
Evaluation of Disclosure Controls and Procedures
As required by Rule 13a-15(e) and 15d-15(e) under the Exchange Act, the Company, with the participation of management, including our Chief Executive Officer and Principal Financial Officer, evaluated the effectiveness of our disclosure controls and procedures (as defined in such rules) as of the end of the period covered by this report. Based on this evaluation, our Chief Executive Officer and Principal Financial Officer concluded that, at June 30, 2026, our disclosure controls and procedures were effective.
Disclosure controls and procedures are controls and other procedures that are designed to ensure that information required to be disclosed in our reports filed or submitted under the Exchange Act is recorded, processed, summarized and reported within the time periods specified in the SEC’s rules and forms. Disclosure controls and procedures include, without limitation, controls and procedures
27
designed to ensure that information required to be disclosed in our reports filed under the Exchange Act is accumulated and communicated to our management, including our Chief Executive Officer and Principal Financial Officer, or persons performing similar functions, as appropriate, to allow timely decisions regarding required disclosure.
Additionally, controls can be circumvented by the individual acts of some persons, by collusion of two or more people, or by management override of the control. The design of any system of controls also is based in part upon certain assumptions about the likelihood of future events, and there can be no assurance that any design will succeed in achieving its stated goals under all potential future conditions; over time, controls may become inadequate because of changes in conditions, or the degree of compliance with the policies or procedures may deteriorate. Because of the inherent limitations in a cost-effective control system, misstatements due to error or fraud may occur and not be detected.
Changes in Internal Control Over Financial Reporting
There were no changes in our internal controls during the three months ended June 30, 2026 that materially affected, or are reasonably likely to materially affect, our internal controls over financial reporting.
28
PART II – OTHER INFORMATION
Item 1. Legal Proceedings
None.
Item 1A. Risk Factors
Other than as set forth below, there have been no material changes to the risk factors disclosed in “Part I – Item 1A. Risk Factors” included in our Annual Report on Form 10-K for the year ended December 31, 2025 filed with the SEC on March 30, 2026.
Risks Related to the Transaction
The Transaction may not be completed on the anticipated timeline or at all.
The completion of the sale of 100% of the membership interests in LCT to ATCC pursuant to the MIPA is subject to numerous closing conditions, many of which are beyond the Company’s control. These conditions include, among others, the accuracy of each party’s representations and warranties, the performance of pre-closing covenants, the absence of a material adverse effect, the absence of any governmental order or restraint prohibiting the Transaction, and the expiration of a 20-day waiting period following the filing of the Information Statement with the SEC under Regulation 14C. If any of these conditions are not satisfied or waived on a timely basis, the closing of the Transaction may be delayed or may not occur at all.
The MIPA provides that either party may terminate the agreement if the closing has not occurred within 60 days of execution (subject to automatic extension in the event of SEC review delays). While stockholder approval has been obtained via written consent of the requisite holders, the Information Statement process with the SEC must be completed before the Transaction can close. Any delays in the SEC review process, difficulties in satisfying the closing conditions, or the occurrence of events that would render the conditions incapable of being satisfied could delay or prevent completion of the Transaction. There can be no assurance that the Transaction will be completed within the anticipated timeframe or at all.
The MIPA may be terminated under certain circumstances, and the Company may be unable to complete the Transaction due to events beyond its control.
The MIPA contains a number of termination provisions that could prevent the Transaction from being completed. The MIPA may be terminated by: (a) mutual written consent of the parties; (b) either party if the closing has not occurred within 60 days (with automatic extension for SEC review delays), provided the terminating party did not cause the failure; (c) either party if a court or other governmental authority issues a final, nonappealable order prohibiting the Transaction; (d) ATCC if the Company breaches its representations, warranties, or covenants and fails to cure within 15 days of notice; (e) the Company if ATCC breaches its obligations and fails to cure within 15 days; or (f) ATCC if the Stockholder Written Consent is not delivered within 24 hours of execution.
Certain of these termination triggers, such as the issuance of a final governmental order or regulatory action prohibiting the Transaction, are entirely beyond the Company’s control. If the MIPA is terminated, the Company will not receive the purchase price or realize the anticipated benefits of the Transaction, and will have incurred significant costs in pursuing the Transaction. Upon termination, no party has further liability to the other, except in the case of fraud or willful and material breach of the MIPA.
If the Transaction is not completed, the Company’s business, financial condition, and stock price may be adversely affected.
If the Transaction is not completed for any reason, the Company may be subject to a number of material risks. The announcement of the Transaction and the subsequent failure to complete it could harm the Company’s reputation with customers, suppliers, and other business partners. The market price of the Company’s common stock may decline to the extent that the current market price reflects an assumption that the Transaction will be completed. In addition, the Company’s management has devoted, and will continue to devote, substantial time and resources to the Transaction, which could otherwise have been directed to other business opportunities and operations.
Furthermore, the failure to complete the Transaction could result in the loss of key employees who may have been retained in anticipation of the Transaction or who may become uncertain about their future with the Company. The Company may also face negative perceptions among investors, analysts, and others in the financial community. Any of these risks, individually or in combination, could have a material adverse effect on the Company’s business, results of operations, financial condition, and stock price.
The Company will be subject to operating restrictions during the period between execution of the MIPA and the closing.
29
Under the terms of the MIPA, the Company is subject to significant operating restrictions during the pre-closing period that limit its ability to conduct the business of LCT in the ordinary course without the prior written consent of ATCC. Among other things, the Company may not, without ATCC’s consent: change the organizational documents of the subsidiary; issue or sell any securities; incur indebtedness; make capital expenditures in excess of $15 thousand individually or $25 thousand in the aggregate per month; acquire any business or material assets; terminate or amend material permits; sell or dispose of material assets; enter into, modify, or terminate material contracts; change employee compensation; or settle litigation above specified thresholds.
These restrictions may prevent the Company from pursuing otherwise attractive business opportunities, responding to competitive developments, or taking actions that the Company’s management might otherwise consider to be in the best interests of the Company and its stockholders. Compliance with these restrictions may impair the Company’s ability to maintain its existing business relationships, retain key personnel, or preserve the value of its business during the pendency of the Transaction.
The announcement and pendency of the Transaction may adversely affect the Company’s business relationships, operating results, and stock price.
The announcement and pendency of the Transaction may create uncertainty for the Company’s customers, suppliers, employees, and other stakeholders. Customers and suppliers may defer purchasing or contracting decisions, seek alternative sources of products or services, or otherwise modify their business relationships with LCT. Competitors may attempt to exploit the uncertainty to attract the Company’s customers, suppliers, or employees. Key employees may seek alternative employment due to uncertainty about their future roles following the Transaction.
In addition, the Company’s stock price may be subject to increased volatility during the pendency of the Transaction. Market participants may speculate about the likelihood of the Transaction being completed, the impact of the Transaction on the Company’s future operations, or the Company’s strategic direction following the closing. These factors could cause the market price of the Company’s common stock to fluctuate significantly, which may adversely affect the Company’s stockholders.
The Company may be required to indemnify ATCC after the closing for breaches of representations and warranties or covenants under the MIPA.
The Company has agreed to indemnify ATCC for damages arising from, among other things: breaches of the Company’s representations and warranties; breaches of the Company’s covenants and agreements; claims by interest holders of the Company; undisclosed indebtedness; transaction expenses; tax liabilities; fraud or willful misconduct; certain employee-related liabilities; and failures related to intellectual property transfers. The Company’s general representations and warranties survive for nine months following the closing, while Specified Representations survive for four years and Fundamental Representations survive for six years.
If ATCC makes indemnification claims against the Company, the Company may be required to pay substantial damages. While the MIPA provides a deductible of $25 thousand for certain claims, indemnification claims may be satisfied first from the escrow funds and then directly from the Company. No party is liable for damages exceeding the proceeds actually received from the Transaction (other than in the case of Fraud). The Company’s exposure to indemnification obligations could be material and could adversely affect the Company’s financial condition.
Risks Related to ISCO Following the Transaction
Following the Transaction, the Company’s operations will be substantially reduced and the Company will be heavily dependent on its remaining business lines.
LCT represents a significant portion of the Company’s current business operations, revenue, and assets. Upon the closing of the Transaction, the Company will divest the entirety of the membership interests in LCT and will no longer derive any revenue, operational support, or strategic benefit from that subsidiary. As a result, the Company’s operations will be substantially reduced and the Company will have significantly fewer employees, revenue streams, and assets with which to sustain its continuing business.
The Company’s remaining business lines may not be sufficient to sustain the Company as a going concern without the development of new revenue sources, strategic acquisitions, or other business initiatives. Investors should be aware that the Company following the Transaction will be a significantly smaller enterprise with greater concentration risk in its remaining operations, and there can be no assurance that those remaining operations will be profitable or sustainable over the long term.
There can be no assurance that the Company will be able to successfully deploy the Transaction proceeds.
The Company expects to receive a purchase price of $25.0 million in connection with the Transaction, subject to customary adjustments for net working capital, closing date cash, and closing date indebtedness, and further subject to the escrow holdbacks described above. Following the closing, the Company will need to identify and evaluate new business opportunities, potential acquisitions, or other uses of capital in order to redeploy the Transaction proceeds in a manner that creates value for stockholders.
30
There can be no assurance that suitable opportunities will be available, that the Company will be able to consummate any such transactions on favorable terms, or that any deployment of the Transaction proceeds will generate acceptable returns. The Company may face significant competition for attractive acquisition targets or investment opportunities, and the Company’s management team may not have the expertise or resources necessary to execute successfully in new business areas. Any failure to deploy the Transaction proceeds effectively could result in diminished returns for stockholders and a decline in the market price of the Company’s common stock.
The Company may face challenges retaining key employees following the Transaction.
In connection with the closing of the Transaction, the LCT employees will transfer to ATCC. The Company’s remaining employees may experience uncertainty regarding their future roles, compensation, and career prospects within a substantially reduced organization. This uncertainty may lead to attrition among key personnel whose skills, experience, and institutional knowledge are critical to the Company’s continuing operations and future strategic initiatives.
The loss of key employees could impair the Company’s ability to execute its remaining business operations, pursue new opportunities, and maintain the relationships necessary for ongoing success. Competition for qualified personnel is intense, and the Company’s reduced size and uncertain strategic outlook following the Transaction may make it more difficult to attract and retain talented employees. Any significant employee departures could have a material adverse effect on the Company’s business, results of operations, and financial condition.
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds
None.
Item 3. Defaults Upon Senior Securities
None.
Item 4. Mine Safety Disclosures
Not applicable.
Item 5. Other Information
During the quarter ended June 30, 2026,
31
Item 6. Exhibits
Exhibit Index
Exhibit |
|
Description |
2.1† |
|
|
3.1 |
|
|
3.2 |
|
|
3.3 |
|
|
3.4 |
|
|
3.5 |
|
|
3.6 |
|
|
3.7 |
|
|
4.1 |
|
|
4.2 |
|
|
4.3 |
|
|
4.4 |
|
|
4.5 |
|
|
10.1 |
|
|
31.1* |
|
Rule 13a-14(a)/15d-14(a) Certification of Chief Executive Officer. |
31.2* |
|
Rule 13a-14(a)/15d-14(a) Certification of Chief Financial Officer. |
32.1* |
|
|
32.2* |
|
|
101.INS* |
|
Inline XBRL Instance Document - the instance document does not appear in the Interactive Data File because its XBRL tags are embedded within the Inline XBRL document |
101.SCH* |
|
Inline XBRL Taxonomy Extension Schema with Embedded Linkbase Documents |
104* |
|
Cover Page Interactive Data File (embedded within the Inline XBRL document) |
* Filed herewith. † Schedules have been omitted pursuant to Item 601(a)(5) of Regulation S-K. The Company hereby undertakes to furnish supplemental copies of any of the omitted schedules upon request by the SEC; provided, that the Company may request confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended, for any schedules so furnished. |
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32
Exhibit |
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Description |
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33
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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INTERNATIONAL STEM CELL CORPORATION |
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Dated: August 13, 2026 |
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By: |
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/s/ ANDREY SEMECHKIN |
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Name: |
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Andrey Semechkin |
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Title: |
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Chief Executive Officer (Principal Executive Officer) |
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By: |
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/s/ RUSSELL KERN |
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Name: |
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Russell Kern |
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Title: |
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Executive Vice President and Chief Scientific Officer (Principal Financial Officer) |
34