LGVN 10-Q
Longeveron Inc. (LGVN)
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM
For the quarterly period ended
OR
For the transition period from to .
Commission File Number:
(Exact name of registrant as specified in its charter)
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(Address of principal executive offices) |
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(Registrant’s telephone number, including area code) |
Securities registered pursuant to Section 12(b) of the Act:
Title of each class |
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Trading Symbol |
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Name of each exchange on which registered |
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The |
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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Accelerated filer |
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Smaller reporting company |
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Emerging growth company |
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If an emerging growth company, indicate by check mark if the registrant has 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 6, 2026, the registrant had
LONGEVERON INC.
TABLE OF CONTENTS
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ITEM 1. |
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Condensed Balance Sheets as of June 30, 2026 (unaudited) and December 31, 2025 |
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2 |
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Condensed Statements of Cash Flows for the six months ended June 30, 2026 and 2025 (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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ITEM 4. |
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ITEM 1. |
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ITEM 1A. |
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ITEM 2. |
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ITEM 3. |
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ITEM 4. |
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ITEM 5. |
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ITEM 6. |
46 |
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47 |
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i
PART I. FINANCIAL INFORMATION
Item 1. Condensed Financial Statements.
Longeveron Inc.
Condensed Balance Sheets
(In thousands, except share and per share data)
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June 30, |
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December 31, |
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(Unaudited) |
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Assets |
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Current assets: |
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Cash and cash equivalents |
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$ |
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$ |
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Prepaid expenses and other current assets |
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Accounts receivable |
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Total current assets |
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Property and equipment, net |
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Intangible assets, net |
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Operating lease asset, net |
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Other assets |
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Total assets |
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$ |
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$ |
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Liabilities and stockholders’ equity |
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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 expenses |
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Current portion of lease liability |
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Deferred revenue |
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Other current liabilities |
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Total current liabilities |
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Long-term liabilities: |
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Long-term portion of operating lease liability |
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Liability related to the sale of future PRV proceeds |
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Other liabilities |
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Total long-term liabilities |
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Total liabilities |
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Stockholders’ equity: |
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Preferred stock, $ |
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Series A non-voting convertible preferred stock, $ |
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Class A common stock, $ |
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Class B 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’ equity |
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Total liabilities and stockholders’ equity |
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$ |
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$ |
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See accompanying notes to unaudited condensed financial statements.
1
Longeveron Inc.
Condensed Statements of Operations
(In thousands, except per share data)
(Unaudited)
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Three months ended |
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Six months ended |
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2026 |
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2025 |
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2026 |
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2025 |
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Revenues |
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Clinical trial revenue |
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$ |
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$ |
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$ |
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$ |
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Contract manufacturing lease revenue |
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— |
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— |
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Contract manufacturing revenue |
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— |
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Total revenues |
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Cost of revenues |
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Gross profit |
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Operating expenses |
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General and administrative |
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Research and development |
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Total operating expenses |
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Loss from operations |
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( |
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Other income |
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Other income, net |
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Total other income, net |
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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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Basic and diluted net loss per share |
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$ |
( |
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$ |
( |
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$ |
( |
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$ |
( |
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Basic and diluted weighted average common shares |
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See accompanying notes to unaudited condensed financial statements.
2
Longeveron Inc.
Condensed Statements of Changes in Stockholders’ Equity
(In thousands, except share amounts)
(Unaudited)
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Class A |
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Class B |
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Series A Non-Voting Convertible Preferred Stock |
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Additional |
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Accumulated |
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Total |
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Number |
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Amount |
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Number |
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Amount |
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Number |
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Amount |
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Capital |
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Deficit |
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Equity |
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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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Class A common stock, issued for RSUs |
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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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Class A common stock, held for taxes on |
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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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Stock issued in private placement, net of |
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— |
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— |
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— |
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— |
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Class A common stock issued in At-The-Market |
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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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Class A common stock issued for warrants |
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— |
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— |
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— |
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— |
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— |
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Conversion of Series A preferred stock for Class |
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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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Conversion of Class B common stock for Class |
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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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Equity-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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See notes to unaudited condensed financial statements.
3
Longeveron Inc.
Condensed Statements of Changes in Stockholders’ Equity
(In thousands, except share amounts)
(Unaudited)
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Class A |
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Class B |
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Additional |
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Accumulated |
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Total |
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Number |
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Amount |
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Number |
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Amount |
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Capital |
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Deficit |
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Equity |
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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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Class A common stock, issued for RSUs |
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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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Class A common stock, held for taxes on |
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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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Equity-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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Cash-for-equity program |
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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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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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See notes to unaudited condensed financial statements.
4
Longeveron Inc.
Condensed Statements of Changes in Stockholders’ Equity
(In thousands, except share amounts)
(Unaudited)
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Class A |
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Class B |
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Series A Non-Voting Convertible Preferred Stock |
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Additional |
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Accumulated |
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Total |
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Number |
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Amount |
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Number |
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Amount |
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Number |
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Amount |
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Capital |
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Deficit |
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Equity |
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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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Class A common stock, issued for |
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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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Class A common stock, held for taxes |
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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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Stock issued in private placement, net |
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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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Class A common stock issued in |
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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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Class A common stock issued for |
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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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Conversion of Series A preferred stock |
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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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Conversion of Class B common stock |
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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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Equity-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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( |
) |
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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See notes to unaudited condensed financial statements.
5
Longeveron Inc.
Condensed Statements of Changes in Stockholders’ Equity
(In thousands, except share amounts)
(Unaudited)
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Class A |
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Class B |
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Additional |
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Accumulated |
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Total |
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Number |
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Amount |
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Number |
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Amount |
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Capital |
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Deficit |
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Equity |
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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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Class A common stock, issued for RSUs |
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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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Class A common stock, held for taxes on |
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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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( |
) |
Equity-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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Cash-for-equity program |
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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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( |
) |
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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See notes to unaudited condensed financial statements.
6
Longeveron Inc.
Condensed Statements of Cash Flows
(In thousands)
(Unaudited)
|
|
Six Months Ended |
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|||||
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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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Adjustments to reconcile net loss to net cash used in operating activities: |
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|
|
|
|
|
||
Depreciation and amortization |
|
|
|
|
|
|
||
Equity-based compensation |
|
|
|
|
|
|
||
Changes in operating assets and liabilities: |
|
|
|
|
|
|
||
Accounts receivable |
|
|
|
|
|
|
||
Prepaid expenses and other current assets |
|
|
( |
) |
|
|
( |
) |
Other assets |
|
|
|
|
|
|
||
Accounts payable |
|
|
|
|
|
|
||
Deferred revenue |
|
|
|
|
|
|
||
Accrued expenses and other current liabilities |
|
|
|
|
|
|
||
Operating lease asset and lease liability |
|
|
( |
) |
|
|
( |
) |
Other liabilities |
|
|
( |
) |
|
|
|
|
Net cash used in operating activities |
|
|
( |
) |
|
|
( |
) |
Cash flows from investing activities |
|
|
|
|
|
|
||
Acquisition of property and equipment |
|
|
( |
) |
|
|
( |
) |
Acquisition of intangible assets |
|
|
( |
) |
|
|
( |
) |
Net cash used in investing activities |
|
|
( |
) |
|
|
( |
) |
Cash flows from financing activities |
|
|
|
|
|
|
||
Proceeds from the issuance of common and preferred stock, net of issuance cost |
|
|
|
|
|
|
||
Proceeds from sale of interest in |
|
|
|
|
|
|
||
Proceeds from warrants exercised, net of issuance cost |
|
|
|
|
|
|
||
Payments for taxes on RSUs vested |
|
|
( |
) |
|
|
( |
) |
Net cash provided by (used in) financing activities |
|
|
|
|
|
( |
) |
|
Change in cash and cash equivalents |
|
|
|
|
|
( |
) |
|
Cash and cash equivalents at beginning of the period |
|
|
|
|
|
|
||
Cash and cash equivalents at end of the period |
|
$ |
|
|
$ |
|
||
Supplement Disclosure of Non-Cash Financing Activities: |
|
|
|
|
|
|
||
Unpaid purchases of property, plant, and equipment in accrued expenses |
|
$ |
|
|
$ |
— |
|
|
Vesting of RSUs into Class A common stock |
|
$ |
( |
) |
|
$ |
( |
) |
See accompanying notes to unaudited condensed financial statements.
7
Longeveron Inc.
Notes to Unaudited Condensed Financial Statements
Six Month Periods Ended June 30, 2026 and 2025
1. Nature of Business, Basis of Presentation, Going Concern and Liquidity
Nature of Business and Basis of Presentation:
Longeveron LLC was formed as a Delaware limited liability company on October 9, 2014 and authorized to transact business in Florida on December 15, 2014. On February 12, 2021, Longeveron LLC converted its corporate form (the “Corporate Conversion”) from a Delaware limited liability company (Longeveron, LLC) to a Delaware corporation, Longeveron Inc. (the “Company,” “Registrant,” “Longeveron,” “we,” “us,” or “our”). The Company is a clinical stage biotechnology company developing regenerative medicines to address unmet medical needs. The Company operates out of its leased facilities in Miami, Florida.
The Company is subject to risks and uncertainties common to early-stage companies in the biotechnology industry, including, but not limited to, development by competitors of new technological innovations, dependence on licenses, protection of proprietary technology, dependence on key personnel, compliance with government regulations and the need to obtain additional financing to fund operations. Investigational product candidates currently under development will require significant additional research and development efforts, including extensive pre-clinical studies and clinical trials and regulatory approval, prior to commercialization. These efforts require significant amounts of additional capital, adequate personnel infrastructure and extensive compliance and reporting capabilities.
The Company’s investigational product candidates are currently in development. There can be no assurance that the Company’s research and development will be successfully completed, that adequate protection for the Company’s intellectual property will be obtained, that any products developed will obtain necessary government regulatory approval or that any approved products will be commercially viable. Even if the Company’s product development efforts are successful, it is uncertain when, if ever, the Company will generate significant revenue from product sales. The Company operates in an environment of rapid technological change and substantial competition from, among others, existing pharmaceutical and biotechnology companies. In addition, the Company is dependent upon the services of its employees, partners and consultants.
The accompanying interim condensed balance sheet as of June 30, 2026, and the condensed statements of operations, statements of changes in stockholders’ equity, and the condensed statements of cash flows for the six months ended June 30, 2026 and 2025, are unaudited. The unaudited condensed financial statements have been prepared according to the rules and regulations of the Securities and Exchange Commission (“SEC”) and, therefore, certain information and disclosures normally included in financial statements prepared in accordance with accounting principles generally accepted in the United States of America (“U.S. GAAP”) have been omitted. In the opinion of management, the accompanying unaudited condensed financial statements for the periods presented reflect all adjustments which are normal and recurring, and necessary to fairly state the financial position, results of operations, and cash flows of the Company. These unaudited condensed financial statements and notes should be read in conjunction with the audited financial statements and notes thereto in the Company’s 2025 Annual Report on Form 10-K filed with the SEC on March 17, 2026.
Going Concern and Liquidity:
Since inception, the Company has primarily been engaged in organizational activities, including raising capital, and research and development activities. The Company does not yet have a product that has been approved by the U.S. Food and Drug Administration (“FDA”), and has only generated revenues from grants, The Bahamas Registry Trial and contract manufacturing. The Company has not yet achieved profitable operations or generated positive cash flows from operations. The Company intends to continue its efforts to raise additional equity financing, develop its intellectual property, and secure regulatory approvals to commercialize its products. There is no assurance that profitable operations, if achieved, could be sustained on a continuing basis. Further, the Company’s future operations are dependent on the success of the Company’s efforts to raise additional capital, its research and commercialization efforts, regulatory approval, and, ultimately, the market acceptance of the Company’s products. These financial statements do not include adjustments that might result from the outcome of these uncertainties.
The Company has incurred recurring losses from operations since its inception, including a net loss of $
As of June 30, 2026, the Company had cash and cash equivalents of $
8
from the Private Placement, will be adequate to fund operations into the fourth quarter of 2026. The Company also has access to an At-The-Market (ATM) equity financing vehicle for the sale of up to $
The Company expects its expenses to continue to increase in connection with ongoing activities, particularly as the Company continues the research and development of, advances the preclinical and clinical activities of, and seeks marketing approval for, its current investigational product candidate. In 2025, the Company began ramping up Biologics License Application (“BLA”) enabling activities, with a focus on clinical spend supporting hypoplastic left heart syndrome ("HLHS") study completion and delivering top-line results. If the current ELPIS II trial in HLHS is successful, and the trial results and other available evidence are deemed sufficient by the FDA to support filing a BLA following the readout of top-line results of the ELPIS II data, then we would intend to pursue a potential BLA filing with the FDA and a commercialization partner. Additionally, following a Type B meeting with the FDA in March 2025 with respect to the Alzheimer's disease (AD) regulatory pathway, the Company is focused on seeking partnership opportunities and/or non-dilutive funding for the AD program, including a proposed single seamless adaptive Phase 2/3 clinical trial. The Company expects that its current operating plan will require increased spending and additional capital investments to support these initiatives, and intends to seek additional financing through capital raises, non-dilutive funding options, and commercial partnering across all indications. There can be no assurance the Company will be able to attain future financing at terms favorable to the Company or at all. In the event the Company is unable to attain the financing needed, it will need to materially revise its current operational plan. The Company may need to adjust its current and future spending levels if needed based on the level of cash available.
The Company has prepared a cash flow forecast which indicates that it does not have sufficient cash to meet its minimum expenditure commitments for one year from the date these financial statements are available to be issued and therefore needs to raise additional funds to continue as a going concern. As a result, there is substantial doubt about the Company’s ability to continue as a going concern.
2. Summary of Significant Accounting Policies
Basis of Presentation:
The condensed financial statements were prepared in accordance with U.S. GAAP, as well as the applicable rules and regulations of the Securities and Exchange Commission.
Use of Estimates:
The presentation of condensed financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. Actual results could differ from those estimates.
New Accounting Pronouncements
From time to time, new accounting pronouncements are issued by the Financial Accounting Standards Board ("FASB") or other standard setting bodies that the Company adopts as of the specified effective date. Unless otherwise discussed below, the Company does not believe that the adoption of recently issued standards have or may have a material impact on its consolidated financial statements or disclosures.
In November 2024, the FASB issued ASU No. 2024-03, Income Statement (Subtopic 220-40): Reporting Comprehensive Income - Expense Disaggregation Disclosures. This standard requires disclosure in the notes to the financial statements, at each interim and annual reporting period, of specified information about certain costs and expense including purchases of inventory, employee compensation, depreciation and intangible asset amortization included in each relevant expense caption. This standard also requires a qualitative description of the amounts remaining in relevant expense captions that are not separately disaggregated, as well as disclosure of the total amount of selling expenses, and, in annual reporting periods, an entity’s definition of selling expenses. This standard is effective for annual reporting for fiscal years beginning after December 15, 2026, and interim periods within fiscal years
9
beginning after December 15, 2027. Early adoption is permitted. The Company is currently evaluating the potential impact that this new standard will have on its consolidated financial statements and related disclosures and expects to apply this standard prospectively upon adoption.
In September 2025, the FASB issued ASU No. 2025-06, Intangibles - Goodwill and Other -Internal-Use Software (Subtopic 350-40): Targeted Improvements to the Accounting for Internal-Use Software. This standard modernizes the accounting for software costs, including updating guidance on the recognition and measurement of costs incurred in connection with development and implementation activities related to internal-use software. This standard is effective for annual reporting for fiscal periods beginning after December 15, 2027, and interim periods within those annual reporting periods. Early adoption is permitted. The Company is currently evaluating the potential impact that this new standard will have on its consolidated financial statements and related disclosures.
In September 2025, the FASB issued ASU No. 2025-07, Derivatives and Hedging (Topic 815) and Revenue from Contracts with Customers (Topic 606): Derivatives Scope Refinements and Scope Clarification for Share-Based Noncash Consideration from a Customer in a Revenue Contract. This standard refines and expands the existing scope exceptions that exclude certain contracts, including certain R&D funding arrangements, from derivative accounting, and clarifies the accounting for share-based noncash consideration received from a customer. This standard is effective for annual reporting for fiscal years beginning after December 15, 2026, and interim periods within those annual reporting periods. Early adoption is permitted. The Company is currently evaluating the potential impact that this new standard will have on its consolidated financial statements and related disclosures.
Cash and Cash Equivalents:
The Company considers cash to consist of cash and cash equivalents and temporary investments having an original maturity of 90 days or less that are readily convertible into cash.
Fair Value Measurement:
The Company measures cash equivalents at fair value. Fair value is defined as an exit price, representing the amount that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants. Fair value is defined as the price the Company would receive to sell an investment in a timely transaction or pay to transfer a liability in a timely transaction with an independent buyer in the principal market, or in the absence of a principal market, the most advantageous market for the investment or liability. A framework is used for measuring fair value utilizing a three-tier hierarchy that prioritizes the inputs to valuation techniques used to measure fair value.
Money market funds are highly liquid investments and are classified as Level 1. The pricing information for these assets is readily available and can be independently validated as of the measurement date.
Accounts Receivable:
Accounts receivable include amounts due from customers. The amounts as of June 30, 2026, and December 31, 2025 are deemed to be collectible, and no amount has been recognized for credit losses. In addition, for the clinical trial revenue, most participants pay in advance of treatment. Advanced grant funds and prepayments for the clinical trial revenue are recorded to deferred revenue. Advance contract manufacturing payments are recorded to deferred revenue.
Accounts receivable by source (in thousands):
|
|
June 30, |
|
|
December 31, |
|
||
Accounts receivable from customers |
|
$ |
|
|
$ |
|
||
Total |
|
$ |
|
|
$ |
|
||
10
Deferred Offering Costs:
The Company recorded certain legal, professional and other third-party fees that were directly associated with in-process equity financings as deferred offering costs until the applicable equity financing was consummated. After consummation of an equity financing, these costs are recorded in stockholders’ equity as a reduction of proceeds generated as a result of the offering.
Property and Equipment:
Property and equipment, including improvements that extend useful lives of related assets, are recorded at cost, while maintenance and repairs are charged to operations as incurred. Depreciation is calculated using the straight-line method based on the estimated useful lives of the assets. Leasehold improvements are amortized over the shorter of the estimated useful life of the asset or the original term of the lease. Depreciation expense is recorded in the research and development line of the condensed statements of operations as the assets are primarily related to the Company’s clinical programs.
Intangible Assets:
Intangible assets include payments on license agreements with the Company’s co-founder and Chief Science Officer (“CSO”) and the University of Miami (“UM”) (see Note 9) and legal costs incurred related to patents and trademarks. License agreements have been recorded at the value of cash consideration, common stock and membership units transferred to the respective parties when acquired.
Payments for license agreements are amortized using the straight-line method over the estimated term of the agreements, which range from
Impairment of Long-Lived Assets:
The Company evaluates long-lived assets for impairment, including property and equipment and intangible assets, when events or changes in circumstances indicate that the carrying value of such assets may not be recoverable. Upon the occurrence of a triggering event, the asset group is reviewed to assess whether the estimated undiscounted cash flows expected from the use of the asset group plus the residual value from the ultimate disposal exceeds the carrying value of the asset group. If the carrying value of the asset group exceeds the undiscounted cash flows, the asset is written down to the estimated fair value. Any resulting
Deferred Revenue:
The unearned portion of advanced grant funds, contract manufacturing revenues, and prepayments for clinical trial revenue, which will be recognized as revenue when the Company meets the respective performance obligations, has been presented as deferred revenue in the accompanying condensed balance sheets.
Warrants:
The Company determines the accounting classification of warrants that are issued, as either liability or equity, by first assessing whether the warrants meet liability classification in accordance with ASC 480-10, Accounting for Certain Financial Instruments with Characteristics of both Liabilities and Equity, (“ASC 480-10”), and then in accordance with ASC 815-40, Derivatives and Hedging - Contracts in Entity’s Own Equity (“ASC 815-40”). Under ASC 480-10, warrants are considered liability-classified if the warrants are mandatorily redeemable, obligate the issuer to settle the warrants or the underlying shares by paying cash or other assets, or must or may require settlement by issuing variable number of shares.
If the warrants do not meet liability classification under ASC 480-10, the Company assesses the requirements under ASC 815-40, which states that contracts that require or may require the issuer to settle the contract for cash are liabilities recorded at fair value, irrespective of the likelihood of the transaction occurring that triggers the net cash settlement feature. If the warrants do not require liability classification under ASC 815-40, in order to conclude equity classification, the Company assesses whether the warrants are indexed to its common shares and whether the warrants are classified as equity under ASC 815-40 or other applicable GAAP. After all relevant assessments are made, the Company concludes whether the warrants are classified as liability or equity. Liability-classified warrants are required to be accounted for at fair value both on the date of issuance and on subsequent accounting period ending dates, with all changes
11
in fair value after the issuance date recorded as a component of other income (expense), net in the statements of operations. Equity-classified warrants are accounted for at consideration received on the issuance date with no changes in fair value recognized after the issuance date. As of June 30, 2026 and December 31, 2025, respectively, all of the Company’s outstanding warrants are equity-classified warrants. (See Note 7).
Revenue Recognition:
The Company recognizes revenue when performance obligations related to respective revenue streams are met.
For clinical trial revenue, the Company considers the performance obligation met when the participant has received the treatment. The Company usually receives prepayment for these services or receives payment at the time the treatment is provided, and there are no remaining performance obligations or variable consideration once the participant received the treatment.
For contract manufacturing revenue, the Company considers the performance obligation met when the contractual obligation and/or statement of work has been satisfied. Additionally, the Company's contract manufacturing agreement includes a lease component, under which customers pay a fixed monthly fee per suite to reserve and maintain a dedicated manufacturing suite with one production line. Customers may also secure additional suites based on capacity needs, which are billed at a fixed fee per suite per month. Furthermore, customers pay the Company a fixed fee per month for storage of in-process samples, vialed harvests for training, and in-process samples for product lots. As these arrangements grant customers the right to control the use of an identified space, the Company classifies the suite reservation fees and storage fees as lease revenue in accordance with ASC 842 Leases. Payment terms may vary depending on specific contract terms. In both 2025 and the first quarter of 2026, the Company derived
The Company records cost of revenues based on expenses directly related to revenue. For the clinical trial revenue directly related expenses for that program are expensed as incurred. These expenses are similar to those described under “Research and development expense” below. For the contract manufacturing, the Company records costs incurred under the contract as cost of revenues.
Research and Development Expense:
Research and development costs are charged to expenses when incurred in accordance with ASC 730 Research and Development. ASC 730 addresses the proper accounting and reporting for research and development costs. It identifies: 1) those activities that should be identified as research and development; 2) the elements of costs that should be identified with research and development activities, and the accounting for these costs; and 3) the financial statement disclosures related to them. Research and development costs include costs such as clinical trial expenses, contracted research and license agreement fees with no alternative future use, supplies and materials, salaries, share-based compensation, employee benefits, property and equipment depreciation and allocation of various corporate costs. The Company accrues for costs incurred by external service providers, based on its estimates of service performed and costs incurred. These estimates include the level of services performed by the third parties, patient enrollment in clinical trials, administrative costs incurred by the third parties, and other indicators of the services completed. Based on the timing of amounts invoiced by service providers, the Company may also record payments made to those providers as prepaid expenses that will be recognized as expenses in future periods as the related services are rendered.
Concentrations of Credit Risk:
Financial instruments which potentially subject the Company to credit risk consist principally of cash and cash equivalents, marketable securities, and accounts and grants receivable. Cash and cash equivalents are held in U.S. financial institutions. At times, the Company may maintain balances in excess of the federally insured amounts.
Income Taxes:
The Company’s tax provision consists of taxes currently payable or receivable, plus any change during the period in deferred tax assets and liabilities. The Company uses the asset and liability method of accounting for income taxes. Under this method, deferred tax assets and liabilities are recognized for the future tax consequences attributable to differences between the financial statement carrying amounts of assets and liabilities and their respective tax basis. Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the years in which those temporary differences are expected to be recovered or settled. The effect on deferred tax assets and liabilities of a change in tax rates is recognized in income in the period that includes the enactment date. In addition, a valuation allowance is established to reduce any deferred tax asset for which it is determined that it is more likely than not that some portion of the deferred tax asset will not be realized. The Company’s tax provision was $
12
and six months ended June 30, 2026 and 2025 due to net operating losses. The Company has not recorded any tax benefit for the net operating losses incurred due to the uncertainty of realizing a benefit in the future.
The Company recognizes the tax benefits from uncertain tax positions that the Company has taken or expects to take on a tax return. In the unlikely event an uncertain tax position exists in which the Company could incur income taxes, the Company would evaluate whether there is a probability that the uncertain tax position taken would be sustained upon examination by a taxing authority. Reserves for uncertain tax positions would then be recorded if the Company determined it is probable that either a position would not be sustained upon examination or a payment would have to be made to a taxing authority and the amount was reasonably estimable. As of June 30, 2026 and December 31, 2025, the Company does not believe it has any uncertain tax positions that would result in the Company having a liability to the taxing authority. It is the Company’s policy to expense any interest and penalties associated with its tax obligations when they are probable and estimable.
Equity-based Compensation:
The Company accounts for equity-based compensation expense by the measurement and recognition of compensation expense for equity-based awards based on estimated fair values on the date of grant. The fair value of the options is estimated at the date of the grant using the Black-Scholes option-pricing model.
The Black-Scholes option-pricing model requires the input of highly subjective assumptions, the most significant of which are the expected share price volatility, the expected life of the option award, the risk-free rate of return, and dividends during the expected term. Because the option-pricing model is sensitive to changes in the input assumptions, different determinations of the required inputs may result in different fair value estimates of the options.
Neither the Company’s stock options nor its restricted stock units (“RSUs”) trade on an active market. Volatility is a measure of the amount by which a financial variable, such as a stock price, has fluctuated (historical volatility) or is expected to fluctuate (expected volatility) during a period. Given the Company’s limited historical data, the Company utilizes the average historical volatility of similar publicly traded companies that are in the same industry. The risk-free interest rate is the average U.S. treasury rate (having a term that most closely approximates the expected life of the option) for the period in which the option was granted. The expected life is the period of time that the options granted are expected to remain outstanding. Options granted have a maximum term of
3. Cash and Cash Equivalents and Fair Value Measurement
The following is summary of cash and cash equivalents that the Company measures at fair value (in thousands):
|
|
Fair Value at June 30, 2026 |
|
|||||||||||||
|
|
Level 1 |
|
|
Level 2 |
|
|
Level 3 |
|
|
Total |
|
||||
Money market funds(1) |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
Accrued income |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Total money market funds |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
|
|
Fair Value at December 31, 2025 |
|
|||||||||||||
|
|
Level 1 |
|
|
Level 2 |
|
|
Level 3 |
|
|
Total |
|
||||
Money market funds(1) |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
Accrued income |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Total money market funds |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
As of June 30, 2026 and December 31, 2025, the Company reported accrued interest receivable related to money market funds of $
13
4. Property and Equipment, Net
Major components of property and equipment are provided in the table below (in thousands):
|
|
Useful Lives |
|
June 30, |
|
|
December 31, |
|
||
Leasehold improvements |
|
|
$ |
|
|
$ |
|
|||
Furniture/Lab equipment |
|
|
|
|
|
|
|
|||
Computer equipment |
|
|
|
|
|
|
|
|||
Software/Website |
|
|
|
|
|
|
|
|||
Total property and equipment |
|
|
|
|
|
|
|
|
||
Less accumulated depreciation and amortization |
|
|
|
|
|
|
|
|
||
Property and equipment, net |
|
|
|
$ |
|
|
$ |
|
||
Depreciation and amortization expense for property and equipment was $
5. Intangible Assets, Net
Major components of intangible assets as of June 30, 2026, are provided in the table below (in thousands):
|
|
Useful Lives |
|
Cost |
|
|
Accumulated |
|
|
Total |
|
|||
License agreements |
|
|
$ |
|
|
$ |
( |
) |
|
$ |
|
|||
Patent costs |
|
|
|
|
|
|
( |
) |
|
|
|
|||
Trademark costs |
|
|
|
|
|
|
|
— |
|
|
|
|
||
Total |
|
|
|
$ |
|
|
$ |
( |
) |
|
$ |
|
||
Major components of intangible assets as of December 31, 2025, are provided in the table below (in thousands):
|
|
Useful Lives |
|
Cost |
|
|
Accumulated |
|
|
Total |
|
|||
License agreements |
|
|
$ |
|
|
$ |
( |
) |
|
$ |
|
|||
Patent costs |
|
|
|
|
|
|
( |
) |
|
|
|
|||
Trademark costs |
|
|
|
|
|
|
|
— |
|
|
|
|
||
Total |
|
|
|
$ |
|
|
$ |
( |
) |
|
$ |
|
||
Amortization expense for intangible assets was less than $
Future amortization expense for intangible assets as of June 30, 2026 is provided in the table below (in thousands):
Years Ending December 31, |
|
Amount |
|
|
2026 (remaining six months) |
|
$ |
|
|
2027 |
|
|
|
|
2028 |
|
|
|
|
2029 |
|
|
|
|
2030 |
|
|
|
|
Thereafter |
|
|
|
|
Total |
|
$ |
|
|
14
6. Leases
The Company has an operating lease for office and laboratory space under an agreement which provides the right to use the underlying asset and requires lease payments during the lease term. The Company recorded a right-of-use operating lease asset and a lease liability related to its operating lease (there are no finance leases). The Company’s lease expires in April 2027. The lease arrangement contains renewal provisions, exercisable at the Company's option. The probability of renewal is not reasonably certain and therefore not included in the right-of-use asset and lease liability. The Company's lease agreement does not contain any material residual value guarantees or material restrictive covenants.
Operating lease cost was $
Information related to leases (in thousands):
|
|
Three Months Ended |
|
|||||
Operating Leases |
|
2026 |
|
|
2025 |
|
||
Operating cash flow information: |
|
|
|
|
|
|
||
Operating lease cost |
|
$ |
|
|
$ |
|
||
Operating lease - cash flow |
|
$ |
|
|
$ |
|
||
|
|
|
|
|
|
|
||
Weighted-average remaining lease term (years) |
|
|
|
|
|
|
||
Weighted-average discount rate (percentage) |
|
|
% |
|
|
% |
||
|
|
Six Months Ended |
|
|||||
Operating Leases |
|
2026 |
|
|
2025 |
|
||
Operating cash flow information: |
|
|
|
|
|
|
||
Operating lease cost |
|
$ |
|
|
$ |
|
||
Operating lease - cash flow |
|
$ |
|
|
$ |
|
||
|
|
|
|
|
|
|
||
Weighted-average remaining lease term (years) |
|
|
|
|
|
|
||
Weighted-average discount rate (percentage) |
|
|
% |
|
|
% |
||
Future minimum payments under the operating leases as of June 30, 2026, are as follows (in thousands):
Years Ending December 31, |
|
Amount |
|
|
2026 (remaining six months) |
|
$ |
|
|
2027 |
|
|
|
|
Total |
|
|
|
|
Less interest ( |
|
|
( |
) |
Total lease liability |
|
$ |
|
|
|
|
|
|
|
Reported as: |
|
|
|
|
Current portion of operating lease liability |
|
$ |
|
|
Long-term portion of lease liability |
|
|
|
|
Total lease liability |
|
$ |
|
|
7. Stockholders’ Equity
Class A and Class B Common Stock
Holders of Class A common stock generally have rights identical to holders of Class B common stock, except that holders of Class A common stock are entitled to
15
On July 1, 2026, the Company’s stockholders approved an amendment to the Company’s Charter to increase the number of shares of Class A common stock authorized to
During the six months ended June 30, 2026, one stockholder converted
Series A Non-Voting Convertible Preferred Stock
The Certificate of Incorporation of the Company, as amended, provides for a class of its authorized stock known as Preferred Stock, consisting of
On March 10, 2026, the Company filed a Certificate of Designation of Preferences, Rights and Limitations of Series A Non-Voting Convertible Preferred Stock with the Secretary of State of the State of Delaware (the “Certificate of Designation”) in connection with the Private Placement. The Certificate of Designation provides for the issuance of up to
In connection with an initial closing of the Private Placement pursuant to a March 10, 2026 Purchase Agreement entered into by and among the Company and certain institutional and accredited investors, on March 11, 2026, the Company issued and sold an aggregate of
Pursuant to the Certificate of Designation, each share of Series A preferred stock is convertible into Class A common stock at a conversion price equal to $
Upon the issuance of the Series A preferred stock, the Company assessed the embedded conversion feature and contingent redemption feature of the securities as described below and determined that such features did not require the Company to separately account for the features as bifurcated embedded derivatives.
In connection with the Private Placement, the Company agreed to issue and sell to the investors in a second closing, subject to certain conditions, additional shares of Class A common stock and Series A preferred stock for aggregate additional gross proceeds of approximately $
16
classified.
The Company also issued to designees of the placement agent (or their assignees) unregistered warrants in connection with the Private Placement to purchase up to
Additionally, the Company sold to the investors in the Private Placement an interest in
The Company allocated the aggregate proceeds received in the Private Placement on a relative fair value basis among the instruments, including Class A common stock, Series A preferred stock, the tranche right associated with the second closing, the placement agent warrants, and the PRV interest, as none of the instruments are measured at fair value on a recurring basis.
In April and May 2026, certain holders of shares of the Company's Series A preferred stock elected to convert
As of June 30, 2026, the Company’s Series A preferred stock consisted of the following (in thousands, except share data):
|
|
June 30, 2026 |
|
|||||||||||||
|
|
Series A Preferred Stock Authorized |
|
|
Series A Preferred Stock Issued and Outstanding |
|
|
Carrying Value |
|
|
Class A Common Stock Issuable Upon Conversion |
|
||||
Series A preferred stock |
|
|
|
|
|
|
|
$ |
|
|
|
|
||||
Warrants
Summary of Warrants Outstanding
During the six months ended June 30, 2026, certain holders of warrants issued in August 2025 exercised warrants to purchase an aggregate of
As of June 30, 2026, warrants exercisable for an aggregate of up to
17
8. Equity Incentive Plan
RSUs
As part of the Company’s IPO, the Company adopted and approved the 2021 Incentive Award Plan, which has been subsequently amended and restated four times (as accordingly amended and restated, the “2021 Incentive Plan”). Under the 2021 Incentive Plan, the Company may grant cash and equity incentive awards to employees and eligible service providers in order to attract, motivate and retain the talent for which the Company competes.
RSUs are taxable upon vesting based on the market value on the date of vesting. The Company is required to make mandatory tax withholding for the payment and satisfaction of income tax, social security tax, payroll tax, or payment on account of other tax related to withholding obligations that arise by reason of vesting of an RSU. The taxable income is calculated by multiplying the number of vested RSUs for each individual by the closing share price as of the vesting date and a tax liability is calculated based on each individual’s tax bracket. During the six months ended June 30, 2026, a total of
As of June 30, 2026 and December 31, 2025, the Company had
RSU activity for the six months ended June 30, 2026 was as follows:
|
|
Number of |
|
|
Outstanding (unvested) at December 31, 2025 |
|
|
|
|
RSU granted |
|
|
|
|
RSUs vested |
|
|
( |
) |
RSU expired/forfeited |
|
|
( |
) |
Outstanding (unvested) at June 30, 2026 |
|
|
|
|
18
Stock Options
Stock options may be granted under the 2021 Incentive Plan. The exercise price of options is equal to the fair market value of the Company’s Class A common stock as of the grant date. Options historically granted have generally become exercisable over or
The fair value of the stock options issued during the six months ended June 30, 2026 was estimated using the Black-Scholes option-pricing model and had the following assumptions: a dividend yield of
Each option grant is being expensed ratably over the option vesting periods, with prorated adjustments made as needed to align with grant dates and applicable service period.
As of June 30, 2026, the Company has recorded issued and outstanding options to purchase a total of
For the six months ended June 30, 2026:
|
|
Number of |
|
|
Stock options vested (based on ratable vesting) |
|
|
|
|
Stock options unvested |
|
|
|
|
Total stock options outstanding at June 30, 2026 |
|
|
|
|
For the year ended December 31, 2025:
|
|
Number of |
|
|
Stock options vested (based on ratable vesting) |
|
|
|
|
Stock options unvested |
|
|
|
|
Total stock options outstanding at December 31, 2025 |
|
|
|
|
Stock option activity for the six months ended June 30, 2026, was as follows:
|
|
Number of |
|
|
Weighted |
|
||
Outstanding at December 31, 2025 |
|
|
|
|
$ |
|
||
Options granted |
|
|
|
|
|
|
||
Options exercised |
|
|
|
|
|
|
||
Options expired/forfeited |
|
|
( |
) |
|
|
|
|
Outstanding at June 30, 2026 |
|
|
|
|
$ |
|
||
For the three months ended June 30, 2026 and 2025, equity-based compensation expense amounted to approximately $
As of June 30, 2026, the remaining unrecognized RSUs compensation of approximately $
19
9. Commitments and Contingencies
Consulting Services Agreement:
On November 20, 2014, the Company entered into a ten-year consulting services agreement with Dr. Joshua Hare, its CSO, under which the Company has agreed to pay the CSO $
In addition, the Company entered into a deferred compensation agreement with the CSO to defer payment of the consulting fees earned for services rendered during 2024, which fees will be paid in a lump sum distribution in February 2027. A similar arrangement was also entered into for 2025. On March 4, 2025 and April 11, 2025, the Company entered into stock option agreements with the CSO as part of a Cash-for-Equity Program. These agreements represent settlement of (i) approximately $
The Compensation Committee increased Dr. Hare's annual compensation to $
As of June 30, 2026, the Company had accrued balances due to the CSO of approximately $
Manufacturing Services Agreement:
On February 21, 2024, the Company entered into a
Following the initial
During 2025, activities under the Secretome Agreement substantially decreased. No additional manufacturing or development activities are planned, and the Company does not anticipate significant future revenue under this arrangement.
For the three months ended June 30, 2026 and 2025, the Company has earned revenues of $
Exclusive Licensing Agreements:
UM Agreements
On November 20, 2014, the Company entered into an Exclusive License Agreement with UM (the “UM License”) for the use of certain Aging-related Frailty Mesenchymal Stem Cell (“MSC”) technology rights developed by our CSO at UM. The UM License is a worldwide, exclusive license, with right to sublicense, with respect to any and all know-how specifically related to the development of
20
the culture-expanded mesenchymal stem cells for Aging-related Frailty used at the Interdisciplinary Stem Cell Institute of UM (“IMSCs”), all standard operating procedures used to create the IMSCs, and all data supporting isolation, culture, expansion, processing, cryopreservation and management of the IMSCs.
The Company is required to pay UM (i) a license issue fee of $
The milestone payment amendments shifted the triggering payments to three payments of $
The Company has the right to terminate the UM License upon 60 days’ prior written notice, and either party has the right to terminate upon a breach of the UM License. To date, the Company has made payments totaling $
The Company also entered into an additional Exclusive License Agreement with UM, signed and effective as of July 18, 2024, for technology rights developed by our CSO at UM. This License is a worldwide, exclusive license, with right to sublicense, with respect to any and all know-how, SOPs, data and all other rights related to UMP-144, entitled “A method to derive GHRHR+ cardiomyogenic cells from pluripotent stem cells ("PSCs") for therapeutic and pharmacologic applications”. UM retained a non-exclusive, royalty-free, perpetual, irrevocable, worldwide right to practice, make, and use the Patent Rights or Technology for any non-profit purposes, including educational, and research purposes. In addition to those certain other royalty payments that would be due should the Company’s sublicense of the technology result in revenue, the Company also agreed to the following additional milestones and payments: $
To date, the Company has made payments totaling $
CD271
On December 22, 2016, the Company entered into an exclusive license agreement with an affiliated entity of Dr. Joshua Hare, JMH MD Holdings, LLC (“JMHMD”), for the use of CD271 cellular therapy technology, pursuant to which the Company is required to pay JMHMD a running royalty in an amount equal to
Under the agreement, the Company is required to use commercially reasonable efforts to achieve the following milestones: (i) submit an investigational new drug application to FDA (or international equivalent) within one year of the effective date of agreement, (ii) initiate a clinical trial utilizing bone marrow derived CD271+ Precursor Cells within three years of the effective date; provided, that any of the milestones may be extended for up to six months for a total of three times by notice and payment of a
21
As of June 30, 2026 and December 31, 2025 there was $
Other Royalty
Under the grant award agreement with the Alzheimer’s Association, the Company may be required to make revenue sharing or distribution of revenue payments for products or inventions generated or resulting from this clinical trial program. The potential payments, although not currently defined, could result in a maximum payment of five times (5x) the award amount of $
Contingencies – Legal
From time to time, the Company could become involved in disputes and various litigation matters that arise in the normal course of business. These may include disputes and lawsuits related to intellectual property, licensing, contract law and employee relations matters. As of June 30, 2026, the Company is not aware of any legal proceedings or material developments requiring disclosure.
10. Employee Benefits Plan
The Company sponsors a defined contribution employee benefit plan (the “Plan”) under the provisions of Section 401(k) of the Internal Revenue Code. The Plan covers substantially all full-time employees of the Company who are eligible upon date of hire. Contributions to the Plan by the Company are at the discretion of the Board of Directors.
The Company contributed approximately $
11. Loss Per Share
Basic and diluted net loss per share have been computed using the weighted-average number of shares of common stock outstanding during the period. We have outstanding equity-based awards that are not used in the calculation of diluted net loss per share because to do so would be anti-dilutive.
The following instruments (in thousands) were excluded from the calculation of diluted net loss per share because their effects would be antidilutive:
|
|
Six Months Ended |
|
|||||
|
|
2026 |
|
|
2025 |
|
||
RSUs |
|
|
|
|
|
|
||
Stock options |
|
|
|
|
|
|
||
Warrants |
|
|
|
|
|
|
||
Total |
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|
|
|
|
|
||
22
12. Segment Information
Operating segments are defined as components of an entity for which discrete financial information is available and regularly reviewed by the Chief Operating Decision Maker (“CODM”) to allocate resources and assess performance. The Company’s ("CEO"), and the Company manages its operations as a operating segment focused on developing regenerative medicines to address unmet medical needs.
The following table is representative of the significant expense categories regularly provided to the CODM when managing the Company’s single reportable segment (in thousands):
|
|
Three Months Ended |
|
|||||
|
|
2026 |
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2025 |
|
||
Revenues(1) |
|
$ |
|
|
$ |
|
||
Less: |
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|
|
|
|
|
||
Cost of revenues |
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|
|
|
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|
||
R&D costs(2) |
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|
||
G&A costs(3) |
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|
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|
||
Personnel costs(4) |
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|
|
|
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|
||
Other segment items(5) |
|
|
|
|
|
|
||
Net loss |
|
$ |
( |
) |
|
$ |
( |
) |
|
|
Six Months Ended |
|
|||||
|
|
2026 |
|
|
2025 |
|
||
Revenues(1) |
|
$ |
|
|
$ |
|
||
Less: |
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|
|
|
|
|
||
Cost of revenues |
|
|
|
|
|
|
||
R&D costs(2) |
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|
||
G&A costs(3) |
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|
||
Personnel costs(4) |
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|
|
|
|
|
||
Other segment items(5) |
|
|
|
|
|
|
||
Net loss |
|
$ |
( |
) |
|
$ |
( |
) |
(1)
(2)
(3)
(4)
(5)
13. Subsequent Events
On July 6, 2026, the Company's Compensation Committee approved special equity awards to the Company's CSO pursuant to the Company’s 2021 Incentive Plan. The awards consist of
23
On August 11, 2026, the Company announced that it has been selected as a Finalist Team in the XPRIZE Healthspan global competition, a seven-year, $
24
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations.
In this document, the terms “Longeveron,” “Company,” “Registrant,” “we,” “us,” and “our” refer to Longeveron Inc. We have no subsidiaries.
This Quarterly Report on Form 10-Q (this “10-Q”) contains forward-looking statements, within the meaning of the Private Securities Litigation Reform Act of 1995, that reflect our current expectations about our future results, performance, prospects and opportunities. Such forward-looking statements can involve substantial risks and uncertainties. All statements other than statements of historical facts contained herein, including statements regarding our future results of operations and financial position, business strategy, prospective products, product approvals, research and development costs, future revenue, timing and likelihood of success, plans and objectives of management for future operations, future results of anticipated products and prospects, plans and objectives of management are forward-looking statements. These statements involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements.
In some cases, you can identify forward-looking statements by terms such as “anticipate,” “believe,” “contemplate,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” or “would” or the negative of these terms or other similar expressions, although not all forward-looking statements contain these words. Factors that could cause actual results to differ materially from those expressed or implied in any forward-looking statements contained in this 10-Q include, but are not limited to, statements about:
25
The forward-looking statements contained in this 10-Q are made on the basis of the views and assumptions of management regarding future events and business performance as of the date this 10-Q is filed with the Securities and Exchange Commission (the “SEC”). We have based these forward-looking statements largely on our current expectations and projections about our business, the industry in which we operate and financial trends that we believe may affect our business, financial condition, results of operations and prospects, and these forward-looking statements are not guarantees of future performance or development. These forward-looking statements speak only as of the date of this 10-Q and are subject to a number of risks, uncertainties and assumptions described in the section titled “Risk Factors” and elsewhere in this 10-Q. Moreover, we operate in a very competitive and rapidly changing environment. New risk factors emerge from time to time, and it is not possible for management to predict all risk factors, nor can we assess the impact of all risk factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements. Because forward-looking statements are inherently subject to risks and uncertainties, some of which cannot be predicted or quantified, you should not rely on these forward-looking statements as predictions of future events. The events and circumstances reflected in our forward-looking statements may not be achieved or occur and actual results could differ materially from those projected in the forward-looking statements. Except as required by applicable law, we do not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, circumstances or otherwise occurring after the date this 10-Q is filed.
In addition, statements that “we believe” and similar statements reflect our beliefs and opinions on the relevant subject. These statements are based upon information available to us as of the date of this 10-Q, and while we believe such information forms a reasonable basis for such statements, such information may be limited or incomplete, and our statements should not be read to indicate that we have conducted an exhaustive inquiry into, or review of, all potentially available relevant information. These statements are inherently uncertain and you are cautioned not to unduly rely upon these statements.
This discussion and analysis should be read in conjunction with our unaudited condensed financial statements and notes thereto included in this 10-Q and the audited condensed financial statements and notes thereto included in our Annual Report on Form 10-K for the year ended December 31, 2025, filed with the SEC on March 17, 2026 (the “2025 Form 10-K”). Operating results are not necessarily indicative of results that may occur in future periods.
Introduction and Overview
We are a clinical stage biotechnology company developing regenerative medicines to address unmet medical needs. Our lead investigational product candidate is laromestrocel, also referred to as Lomecel-B®.
Laromestrocel is a proprietary, scalable, allogeneic cellular therapy that has multiple potential modes of action that include pro-vascular, pro-regenerative, and anti-inflammatory mechanisms that collectively appear to promote tissue repair and healing. Laromestrocel possesses broad potential applications across a spectrum of disease areas. Our mission is to continue to advance the development and regulatory approval of laromestrocel in order to make it available for patients who may need it.
Our stem cell therapy development programs address life-threatening conditions in the most vulnerable populations - children and the elderly: Hypoplastic Left Heart Syndrome; Alzheimer’s disease; Pediatric Dilated Cardiomyopathy and Aging-related Frailty. We plan to pursue a robust partnering and commercial licensing strategy across our development programs to accelerate potential time to market, increase capital use efficiency and leverage the greater resources of larger organizations.
Since our founding in 2014, we have focused the majority of our time and resources on the following: organizing and staffing our company, building, staffing and equipping a current good manufacturing practice (“cGMP”) manufacturing facility with research and development labs, business planning, raising capital, establishing and maintaining our intellectual property portfolio, generating clinical safety and efficacy data in our selected disease conditions and indications, and developing and expanding our manufacturing processes and capabilities to support both internal and external development programs.
We manufacture our own investigational product candidates for early-phase clinical trials and have augmented our Chemistry, Manufacturing and Controls ("CMC") infrastructure to support potential future Biologics License Application ("BLA") submissions. These efforts include planning for process and analytical method validation as well as planning for commercial production readiness. As part of our ongoing preparations for a potential BLA submission for our lead investigational product candidate for Hypoplastic Left Heart Syndrome ("HLHS"), we made a strategic decision to pursue commercial manufacturing through a third-party contract development and manufacturing organization ("CDMO") at the appropriate time, rather than renovating our existing Miami facility for commercial-scale production. This decision was based on a comprehensive evaluation of multiple factors, including cost, timeline
26
feasibility, and scalability. We believe this approach offers a more cost-effective and timely path to support our potential BLA submission and commercial launch. Our Miami manufacturing facility, which includes eight clean rooms, two research and development laboratories, and warehouse and storage space, will continue to support clinical development, research and early-phase manufacturing for our current and future clinical trials. We have supply contracts with multiple third parties for fresh bone marrow, which we use to produce our investigational product candidate for clinical testing and research and development. From time to time, we enter into contract development and manufacturing contracts or arrangements with third parties who seek to utilize our product development, manufacturing, and testing capabilities.
Financial Overview
As of June 30, 2026, we have sold 28,230,871 shares of Class A Common Stock, par value $0.001 per share (the "Class A common stock") and 11,873.04 shares of Series A Non-Voting Convertible Preferred Stock, par value $0.001 per share (the "Series A preferred stock") through our IPO and subsequent follow-on public and private equity offerings and transactions. Additionally, as of June 30, 2026, warrants exercisable for an aggregate of up to 21,238,731 shares of our Class A common stock remain outstanding at exercise prices ranging from $0.65 per share to $175.00 per share.
In connection with a review of our cash runway and cost structure and following approval from the Board of Directors (the "Board"), the Company implemented a temporary reduction in the compensation or fees payable, as applicable, of its executive officers and Board, effective on or about February 16, 2026, at rates ranging from 25% to 50%. The Company further indicated that it intended to restore compensation and fees to the amounts in effect immediately prior to such reductions at such time as the Company secured sufficient financing or other sources of capital.
Following the initial closing of the March 2026 private placement financing discussed below (the "Private Placement"), and its good-faith determination of its financial ability to do so, the Company repaid the members of its executive leadership team an amount equal to the difference between such executive’s base salary or fee structure in effect immediately prior to the reduction and the reduced salary or fees paid during the applicable reduction period. The Company undertook the same determination with respect to Board fees and restored Board compensation to its previously established levels. Concerning the Board, because both the temporary reduction in fees and the reinstatement of such fees occurred prior to the first payment of such fees due for 2026, no repayment of any temporarily reduced fees was necessary by the Company.
On March 11, 2026, the Company completed the initial closing of the Private Placement previously described in its Quarterly Report on Form 10-Q for the quarter ended March 31, 2026, resulting in gross proceeds of approximately $15.9 million, before deducting placement agent fees and offering expenses. The initial closing included the issuance of Class A common stock, Series A preferred stock convertible into Class A common stock, placement agent warrants, and the sale of an interest in a portion of the potential future proceeds from the sale of a Rare Pediatric Disease Priority Review Voucher ("PRV"). The Private Placement also contemplated a second closing, subject to the satisfaction or waiver of certain closing conditions. See "Liquidity, Capital Resources, and Going Concern—Capital Raising Efforts" below for additional information regarding the Private Placement.
We do not yet have a product that has been approved by the FDA, and have only generated revenues from grants, The Bahamas Registry Trial and contract manufacturing. We have not yet achieved profitable operations or generated positive cash flows from operations. We have incurred recurring losses from operations since our inception, and as of June 30, 2026 we had an accumulated deficit of $143.1 million. We expect to continue to generate operating losses for the foreseeable future. As a result of the March 2026 Private Placement financing, and based on current operating plans, we expect that our cash and cash equivalents as of June 30, 2026, which include proceeds from the initial closing of the Private Placement, will be adequate to fund operations into the fourth quarter of 2026. The Company also has access to an At-The-Market (ATM) equity financing vehicle for the sale of up to $10.7 million aggregate market value of shares of the Company’s Class A common stock, of which $9.3 million remains available; however, the ATM facility was under a standstill restriction until June 9, 2026, and thereafter we have restrictions in place regarding our ability to use the ATM facility unless our Class A common stock is trading above $0.80 per share until September 7, 2026. We expect that our current operating plan will require increased spending and additional capital investments to support these initiatives and we intend to seek additional financing through capital raises, non-dilutive funding options, and commercial partnering across all indications. There can be no assurance we will be able to attain future financing at terms favorable to us or at all. In the event we are unable to attain the financing needed, we will need to materially revise our current operational plans.
We have prepared a cash flow forecast which indicates that we do not have sufficient cash to meet our minimum expenditure commitments for one year from the date these financial statements are available to be issued and therefore we need to raise additional funds to continue as a going concern. As a result, there is substantial doubt about our ability to continue as a going concern.
27
Operational Overview
We are currently in clinical development of a single investigational product candidate, laromestrocel, for four potential indications: HLHS, Alzheimer’s disease (“AD”), Pediatric Dilated Cardiomyopathy (“pediatric DCM”), and Aging-related Frailty.
Figure 1: Laromestrocel clinical development pipeline
*Phase 2b ELPIS II study; enrollment completed June 24, 2025
** Not currently active
*** We plan to conduct a single Phase 2 registrational clinical trial in accordance with the Investigational New Drug (“IND”) application which became effective in July 2025.
As of June 2026, we have completed five U.S. clinical studies of laromestrocel: ELPIS I Phase 1 (HLHS), Phase 1 and Phase 2a “CLEAR MIND Trial” (AD), Phase 1/2 and Phase 2b Aging-related Frailty. We currently have one fully enrolled, ongoing clinical trial: ELPIS II Phase 2b (HLHS). Additionally, we sponsor a registry in The Bahamas under the approval and authority of the National Stem Cell Ethics Committee, now known as the National Longevity and Regenerative Therapy Ethics Review Committee ("The Bahamas Registry Trial"). The Bahamas Registry Trial may administer laromestrocel to eligible participants at private clinics in Nassau, The Bahamas for a variety of indications. While laromestrocel is considered an investigational product in The Bahamas, under the approval terms from the National Stem Cell Ethics Committee, we are permitted to charge a fee to participate in The Bahamas Registry Trial.
In June 2026, we announced that the Company has been granted Small or Medium-sized Enterprise (SME) status by the European Medicines Agency (EMA). The SME program is an initiative by the EMA to address the particular needs of small and medium size companies developing medicinal products in Europe. Companies that are granted SME designation are able to seek scientific advice, protocol assistance, and other information and training from dedicated EMA personnel during the clinical development process. Companies with this designation can engage in early dialogue with the EMA multidisciplinary team and discuss regulatory strategy with the goal of mitigating delay and accelerating patient access to lifesaving treatments. In addition, SME designation gives companies reduced administrative fees throughout the development process.
Our current objective is to license or otherwise forge strategic collaborations and/or partnerships for the advancement of laromestrocel in all four potential indications.
Hypoplastic Left Heart Syndrome (HLHS)
HLHS is a rare congenital heart condition affecting approximately 1,000 newborns in the U.S. annually. HLHS is a birth defect that affects normal blood flow through the heart. As the baby develops during pregnancy, the left side of the heart does not form correctly so that babies are born with an underdeveloped or absent left ventricle. It is one type of congenital heart defect present at birth. Because a baby with this defect needs surgery or other procedures soon after birth, HLHS is considered a critical congenital heart defect. To prevent certain death shortly after birth, these babies undergo a series of three heart surgeries (staged surgical palliation) that reconfigures the single right ventricle to support systemic circulation. Despite these life-saving surgeries, HLHS patients nevertheless still have high early mortality and morbidity rates due primarily to heart failure. We are exploring the possibility that laromestrocel, when administered directly to the myocardium of affected infants, can improve outcomes in this devastating rare pediatric disease.
The FDA granted Rare Pediatric Disease Designation (“RPD”) for laromestrocel for the treatment of HLHS (November 8, 2021), Orphan Drug Designation (“ODD”) (December 2, 2021), and Fast Track Designation (August 24, 2022). We are currently conducting an ongoing
28
Phase 2b clinical trial (ELPIS II) under FDA IND 17677. ELPIS II is a multi-center, randomized, double-blind, controlled clinical trial designed to evaluate laromestrocel as an adjunct therapy to the standard-of-care second-stage HLHS heart reconstructive surgery which is typically performed at 4-6 months after birth. The current primary objective is to evaluate change in right ventricular ejection fraction after laromestrocel treatment versus standard-of-care surgery alone (40 subjects total: 20 per arm).
ELPIS II is a next-step trial to our completed 10-patient open-label Phase 1 trial (ELPIS I) under the same IND. The ELPIS I trial was designed to evaluate the safety and tolerability of laromestrocel as an adjunct to the second-stage HLHS surgery, and to obtain preliminary evidence of laromestrocel effect to support a next-phase trial. The primary safety endpoint was met: no major adverse cardiac events (“MACE”) or treatment-related infections during the first month post-treatment, and no triggering of stopping rules. Furthermore, fluid-based and imaging biomarker data supported multiple potentially relevant mechanisms-of-action of laromestrocel, and the potential to improve post-surgical heart function. We currently anticipate top-line results from ELPIS II in September 2026.
On May 8, 2026, the Company announced that a constructive Type C meeting with the FDA was held in late March 2026, with the FDA providing their meeting summary in late April to discuss the ongoing development of laromestrocel.
In the Type C meeting, the FDA acknowledged that HLHS is a rare disease associated with significant morbidity and mortality with a high unmet medical need for safe and effective therapies, but also asserted that the primary endpoint of right ventricle ejection fraction (RVEF) in the ELPIS II trial is not an appropriate endpoint to demonstrate efficacy. While Longeveron agreed with the FDA regarding the insufficiency of RVEF as the primary endpoint, and was prepared to discuss other potentially appropriate endpoints sufficient to demonstrate efficacy, the FDA indicated that given the interim analysis mandated and conducted by the National Institute of Health (NIH) during the trial (to which the Company was and remains blinded), a new primary endpoint could not be agreed to while the trial is still ongoing. Without an agreed upon primary endpoint sufficient for efficacy, the FDA no longer refers to the ELPIS II trial as pivotal, as had been specifically discussed in the Company’s Type C meeting in 2024. Nevertheless, the FDA expressly agreed that it is willing to meet with Longeveron again when the ongoing ELPIS II study is completed to discuss the study results and align on a potential path forward. The FDA further indicated that only the most objective measures, including, all-cause mortality, cardiac transplant-free survival, event of cardiac transplantation, and well-defined major adverse cardiac events (MACE), could be informative of efficacy in ELPIS II, and in that regard, the Company is capturing all of these measures in ELPIS II along with some additional key measures to support an efficacy determination. In June 2026, the Company submitted to the FDA a Sponsor Statistical Analysis Plan (SAP) for ELPIS II with a composite primary endpoint and secondary endpoints for the FDA’s review and approval, and remains optimistic that the trial results and other available evidence will be sufficient to support filing a BLA following the readout of top-line results of the ELPIS II data.
In May 2026, we announced that the independent Data Monitoring Committee (DMC) completed its final pre-specified data review for ELPIS II. The DMC performed a risk-benefit assessment, indicated no safety concerns, and approved the study to continue as designed to completion.
We have filed patent applications relating to the administration of laromestrocel for treating HLHS in Australia, The Bahamas, Canada, China, the European Patent Office, Japan, Hong Kong, South Korea, Taiwan, and the United States.
Alzheimer’s Disease (AD)
AD, a devastating neurologic disease leading to cognitive decline, currently has very limited therapeutic options. An estimated 6.7 million Americans aged 65 and older have AD, and this number is projected to more than double by 2060. In September 2023, we completed our Phase 2a AD clinical trial, known as the CLEAR MIND trial. This trial enrolled patients with mild AD and was designed as a randomized, double-blind, placebo-controlled study across ten U.S. centers. Our primary objective was to assess safety, and preliminary efficacy for three distinct laromestrocel dosing regimens against placebo.
The study demonstrated positive results. The safety profile of laromestrocel was safe and well tolerated when administered as single or multiple doses, with no incidence of hypersensitivity or infusion-related reactions. In addition, there were no cases of amyloid-related imaging abnormalities (ARIA). With regard to efficacy, laromestrocel showed slowing/prevention of disease worsening relative to placebo. The unadjusted p-values for a several secondary efficacy endpoint composite AD score (“CADS”) for both the low-dose laromestrocel group and the pooled treatment groups compared to placebo suggested significance, indicating potential signals of efficacy. Other doses also indicated promising results in slowing/prevention of disease worsening. Additionally, an improvement versus placebo was observed in the Montreal Cognitive Assessment (“MoCA”) and in the activity of daily living observed by a caregiver and measured by Alzheimer’s disease Cooperative Study Activities of Daily Living (“ADCS-ADL”) with unadjusted p-values suggestive of significance. The study indicated potential preservation of the brain volumes in some but not all AD related areas of the brain 39 weeks after treatment commenced. Brain magnetic resonance imaging (“MRI”) results demonstrated a 48% reduction in whole brain volume loss, 62% reduction in hippocampal volume loss, and potential improvement in neuroinflammation in some but not all brain
29
regions via diffusion tensor imaging (DTI).
Based on these results, in July 2024, the FDA granted Regenerative Medicine Advanced Therapy (“RMAT”) Designation and Fast Track designation to laromestrocel for the treatment of mild AD.
We believe laromestrocel is the only investigational product candidate to be granted RMAT designation for mild AD to date. In March 2025, Longeveron announced a productive Type B Meeting with the FDA supporting the advancement of laromestrocel as a potential treatment for mild AD. As a result of the Type B meeting, we reached tentative alignment with the FDA on the overall study design for a proposed single, seamless adaptive Phase 2/3 clinical trial, including proposed AD patient population, proposed placebo control, laromestrocel dose selection and frequency, trial duration, and trial endpoints that, if positive, could be acceptable for potential BLA submission for Alzheimer’s disease. We are actively seeking to forge strategic collaborations and/or partnerships for the advancement of laromestrocel in addressing mild AD.
We have filed patent applications relating to the treatment of AD using laromestrocel in Australia, The Bahamas, Canada, China, the European Patent Office, Hong Kong, Israel, Japan, New Zealand, South Korea, Singapore, South Africa, and the United States. We have also filed another family of patent applications relating to improving Brain Architecture in Alzheimer’s disease using laromestrocel in The Bahamas, Taiwan, in addition to an application under the Patent Cooperation Treaty (PCT).
Aging-related Frailty
Improvement of the quality of life for the aging population is one of the strategic directions of the Company. Life expectancy has substantially increased over the past century due to medical and public health advancements. However, this longevity increase has not been paralleled by healthspan – the period of time one can expect to live in relatively good health and independence. For many developed and developing countries, health span lags life expectancy by over a decade. This has placed tremendous strain on healthcare systems in the management of aging-related ailments and presents additional socioeconomic consequences due to patient decreased independence and quality-of-life. Since these strains continue to increase with demographic shifts towards an increasingly older population, improving health span has become a priority for health agencies, such as the National Institute on Aging (“NIA”) of the National Institutes of Health (“NIH”), the Japanese Pharmaceuticals and Medical Devices Agency (“PMDA”), and the European Medicines Agency (“EMA”). As we age, we experience a decline in our own stem cells, a decrease in immune system function (known as “immunosenescence”), diminished blood vessel functioning, chronic inflammation (known as “inflammaging”), and other aging-related alterations that affect biological functioning. In April 2024, we discontinued our clinical trial in Japan to evaluate laromestrocel for Aging-related Frailty. We plan to continue enrolling patients on the Frailty and Cognitive Impairment registry trials in The Bahamas and also plan to launch an Osteoarthritis registry trial.
Laromestrocel data from its Phase 2b clinical trial in Aging-related Frailty were published in Cell Stem Cell in February 2026. The Phase 2b results indicated that intravenous laromestrocel improved the physical condition of patients with age-related clinical frailty after nine months, compared to placebo.
Pediatric Dilated Cardiomyopathy (DCM)
DCM is a rare and life-threatening cardiovascular condition with unmet medical needs. Pediatric cardiomyopathies affect at least 100,000 children worldwide. DCM is the most common form of cardiomyopathy in children. About 50 to 60 percent of all pediatric cardiomyopathy cases are diagnosed as dilated. DCM is characterized by dilation and impaired systolic function of the left ventricle or both ventricles, typically in the absence of ischemia, abnormal loading conditions, or physiologic insult (e.g., sepsis). Diagnostic criteria for DCM include reduced measures of ventricular function combined with increased ventricular volumes adjusted for body size on cardiac imaging (left ventricular end-diastolic diameter (LVEDD) and left ventricular end-systolic diameter (LVESD) z-scores > 2). Treatments for DCM aim to ameliorate symptoms, reduce progression of disease, and prevent life-threatening arrhythmias. Treatment for DCM remains a complex challenge, marked by several limitations.
Clinical data to date with laromestrocel (a MSC therapy) indicates an acceptable safety profile in various disease indications administered via either IV or intramyocardial injection. Additionally, the safety profile from MSC therapies in general has been acceptable, supported by the literature review showing that MSC therapy has been evaluated in over one thousand clinical trials globally, with a favorable safety profile across numerous disease indications. DCM is associated with the loss of cardiomyocytes and with the replacement of lost cardiomyocytes by noncontractile fibrous tissue. Results from preclinical and clinical trials highlight the potential of MSC therapy to promote cardiomyogenesis, reduce inflammation and fibrosis, and support neovascularization. In adults with both ischemic cardiomyopathy and nonischemic dilated cardiomyopathy (DCM), MSC therapies have demonstrated improved LV function, functional status, and quality of life (QoL). Pediatric patients with DCM may be ideal candidates for MSC therapy because their hearts, including cardiomyocytes and progenitor cells, are more responsive to the signals from transplanted stem cells. Cell therapies have shown positive outcomes in DCM and other conditions, but further research is needed to confirm long-term safety and efficacy.
30
Our IND application for laromestrocel as a potential treatment for pediatric DCM became effective in July 2025. This IND provides for moving directly to a single Phase 2 registrational clinical trial currently targeted for 2027, subject to financing, with planning and preparation beginning in 2026. If this trial is successful, we would then seek to partner the program for further development and potential commercialization.
Summary of Clinical Development Strategy
Our core strategy is to become a world-leading regenerative medicine company through the development, approval, and commercialization of novel cell therapy products for unmet medical needs, with a near-term focus on HLHS. Key elements are as follows.
31
Components of Our Results of Operations
Revenue
We have generated revenue from two sources:
Cost of Revenues
We record cost of revenues based on expenses directly related to revenue. For the clinical trial revenue, directly related expenses for that program are allocated and accrued as incurred. These expenses are similar to those described under “Research and Development Expenses” below. For contract manufacturing revenue, directly related expenses for the services and facilities provided under the contract are recorded as cost of revenues.
Research and Development Expenses
Research and development costs are charged to expense when incurred in accordance with Financial Accounting Standards Board (“FASB”) Accounting Standards Codification (“ASC”) 730 Research and Development. ASC 730 addresses the proper accounting and reporting for research and development costs. It identifies: (1) those activities that should be identified as research and development; (2) the elements of costs that should be identified with research and development activities, and the accounting for these costs; and (3) the financial statement disclosures related to them.
Research and development expenses include costs such as clinical trial expenses, contracted research and manufacturing, license agreement fees with no alternative future use, supplies and materials, salaries, equity-based compensation, employee benefits, property and equipment depreciation and allocation of various corporate costs. We accrue for costs incurred by external service providers, including clinical investigators, based on estimates of service performed and costs incurred. These estimates include the level of services performed by the third parties, subject enrollment in clinical trials, administrative costs incurred by the third parties, and other indicators of the services completed. Based on the timing of amounts invoiced by service providers, we may also record payments made to those providers as prepaid expenses that will be recognized as expense in future periods as the related services are rendered.
We currently do not carry any inventory for our investigational product candidates, as we have yet to launch a product for commercial distribution. Historically our operations have focused on conducting clinical trials, product research and development efforts, and improving and refining our manufacturing processes, and accordingly, manufactured clinical doses of investigational product candidates were expensed as incurred, consistent with the accounting for all other research and development costs. Once we begin commercial distribution, all newly manufactured approved products will be allocated either for use in commercial distribution, which will be carried as inventory and not expensed, or for research and development efforts, which will continue to be expensed as incurred.
Subject to obtaining necessary financing, we expect that our research and development expenses will continue to be significant in the future as we support increased research and development activities relating to our clinical programs, as well as incur additional expenses related to our clinical trials.
32
General and Administrative Expenses
General and administrative expenses consist primarily of salaries and other related costs, including equity-based compensation, for personnel in our executive, finance, business development, and administrative functions. General and administrative expenses also include public company related expenses; legal fees relating to corporate matters; insurance costs; professional fees for accounting, auditing, tax and consulting services; travel expenses; rent and facility-related expenses, direct depreciation costs and other operating costs.
Other Income and Expenses
We earn interest income on cash equivalents and money market funds. Other income and expense also includes items incurred that are not part of our normal operations.
Income Taxes
No provision for income taxes has been recorded for the three and six months ended June 30, 2026 and 2025. We may incur income taxes in the future if we have earnings. At this time, we have not evaluated the impact of any future profits.
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, together with the changes in those items in dollars (in thousands):
|
|
Three Months Ended |
|
|
Increase |
|
||||||
|
|
2026 |
|
|
2025 |
|
|
(Decrease) |
|
|||
Revenues |
|
$ |
287 |
|
|
$ |
316 |
|
|
$ |
(29 |
) |
Cost of revenues |
|
|
105 |
|
|
|
170 |
|
|
|
(65 |
) |
Gross profit |
|
|
182 |
|
|
|
146 |
|
|
|
36 |
|
Expenses |
|
|
|
|
|
|
|
|
|
|||
General and administrative |
|
|
3,159 |
|
|
|
2,589 |
|
|
|
570 |
|
Research and development |
|
|
3,194 |
|
|
|
2,954 |
|
|
|
240 |
|
Total operating expenses |
|
|
6,353 |
|
|
|
5,543 |
|
|
|
810 |
|
Loss from operations |
|
|
(6,171 |
) |
|
|
(5,397 |
) |
|
|
(774 |
) |
Other income |
|
|
98 |
|
|
|
369 |
|
|
|
(271 |
) |
Net loss |
|
$ |
(6,073 |
) |
|
$ |
(5,028 |
) |
|
$ |
(1,045 |
) |
Revenues, Cost of Revenues and Gross Profit: Revenues for each of the three-month periods ended June 30, 2026 and June 30, 2025 was $0.3 million. 2026 revenues decreased by $29,000, or 10%, when compared to 2025, primarily due to the absence of contract manufacturing revenue.
Clinical trial revenue, which is derived from The Bahamas Registry Trial, for each of the three-month periods ended June 30, 2026 and June 30, 2025 was $0.3 million. Contract manufacturing revenues for the three months ended June 30, 2026 and 2025, were $0 and $18,000, respectively. This decrease of $18,000, or 100%, when compared to the same period in 2025, was driven by the absence of any additional contract manufacturing services from our third-party client.
Related cost of revenues were $0.1 million and $0.2 million for the three months ended June 30, 2026 and 2025, respectively. This resulted in a gross profit of approximately $0.2 million for the three months ended June 30, 2026, an increase of $36,000, or 25%, when compared to 2025.
General and Administrative Expenses: General and administrative expenses for the three months ended June 30, 2026 were $3.2 million, compared to $2.6 million for the same period in 2025. The increase of $0.6 million, or 23%, was primarily due to a $0.4 million increase in legal spend and a $0.2 million increase in personnel-related costs.
33
Research and Development Expenses: Research and development expenses were $3.2 million for the three months ended June 30, 2026, compared to $3.0 million for the same period in 2025. The increase of $0.2 million, or 7%, was due to higher clinical trial expenses to support the ELPIS II top-line results expected in September 2026.
Research and development expenses consisted primarily of the following items (in thousands):
|
|
Three Months Ended |
|
|||||
|
|
2026 |
|
|
2025 |
|
||
Employee compensation and benefits |
|
$ |
1,634 |
|
|
$ |
1,588 |
|
CMC |
|
|
174 |
|
|
|
129 |
|
Clinical trial expenses-statistics, monitoring, labs, sites, etc. |
|
|
771 |
|
|
|
610 |
|
Depreciation |
|
|
185 |
|
|
|
191 |
|
Equity-based compensation |
|
|
176 |
|
|
|
171 |
|
Amortization |
|
|
36 |
|
|
|
72 |
|
Travel |
|
|
23 |
|
|
|
59 |
|
Other activities |
|
|
195 |
|
|
|
134 |
|
|
|
$ |
3,194 |
|
|
$ |
2,954 |
|
Other Income: Other income for the three months ended June 30, 2026 was $0.1 million, primarily consisting of interest earned on money market funds. Other income for the three months ended June 30, 2025, was $0.4 million, primarily consisting of $250,000 received as a recipient of a Milestone 1 Award in the XPRIZE Healthspan competition and $0.1 million of interest earned on money market funds.
Net Loss: Net loss was $6.1 million for the three months ended June 30, 2026, compared to $5.0 million for the three months ended June 30, 2025. The increase of $1.1 million, or 22%, was due to the factors outlined above.
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, together with the changes in those items in dollars (in thousands):
|
|
Six Months Ended |
|
|
Increase |
|
||||||
|
|
2026 |
|
|
2025 |
|
|
(Decrease) |
|
|||
Revenues |
|
$ |
685 |
|
|
$ |
697 |
|
|
$ |
(12 |
) |
Cost of revenues |
|
|
239 |
|
|
|
276 |
|
|
|
(37 |
) |
Gross profit |
|
|
446 |
|
|
|
421 |
|
|
|
25 |
|
Expenses |
|
|
|
|
|
|
|
|
|
|||
General and administrative |
|
|
5,879 |
|
|
|
5,530 |
|
|
|
349 |
|
Research and development |
|
|
5,513 |
|
|
|
5,469 |
|
|
|
44 |
|
Total operating expenses |
|
|
11,392 |
|
|
|
10,999 |
|
|
|
393 |
|
Loss from operations |
|
|
(10,946 |
) |
|
|
(10,578 |
) |
|
|
(368 |
) |
Other income |
|
|
137 |
|
|
|
539 |
|
|
|
(402 |
) |
Net loss |
|
$ |
(10,809 |
) |
|
$ |
(10,039 |
) |
|
$ |
(770 |
) |
Revenues, Cost of Revenues and Gross Profit: Revenues for each of the six-month periods ended June 30, 2026 and June 30, 2025, was $0.7 million. 2026 revenues decreased by $12,000, or 2%, due to lower contract manufacturing revenue offset by increased participant demand for our Bahamas Registry Trial.
Clinical trial revenues for the six months ended June 30, 2026 increased $0.1 million, or 19%, when compared to the same period in 2025, as a result of greater participant demand for our Bahamas Registry Trial. Contract manufacturing revenues for the six months ended June 30, 2026 decreased $0.1 million, or 85%, when compared to the same period in 2025, driven by the absence of additional contract manufacturing services from our third-party client.
34
Related cost of revenues were $0.2 million and $0.3 million for the six months ended June 30, 2026 and 2025, respectively. This resulted in a gross profit of $0.4 million in each of the six months ended June 30, 2026 and 2025.
General and Administrative Expense: General and administrative expenses for the six months ended June 30, 2026 were $5.9 million, compared to $5.5 million for the same period in 2025. The increase of $0.4 million, or 7%, was primarily due to higher legal and accounting costs of $0.7 million, partially offset by a decrease in personnel-related costs of $0.3 million.
Research and Development Expenses: Research and development expenses were $5.5 million for each of the six month periods ended June 30, 2026 and June 30, 2025. The increase of $44,000, or 1%, was due to higher clinical trial expenses of $0.3 million to support the ELPIS II top-line results expected in September 2026, partially offset by a non-recurring charge for amortization expense related to patent costs recorded in the 2025 period of $0.2 million.
Research and development expenses consisted primarily of the following items (in thousands):
|
|
Six Months Ended |
|
|||||
|
|
2026 |
|
|
2025 |
|
||
Employee compensation and benefits |
|
$ |
2,889 |
|
|
$ |
2,928 |
|
CMC |
|
|
248 |
|
|
|
250 |
|
Clinical trial expenses-statistics, monitoring, labs, sites, etc. |
|
|
1,269 |
|
|
|
975 |
|
Depreciation |
|
|
370 |
|
|
|
379 |
|
Equity-based compensation |
|
|
324 |
|
|
|
312 |
|
Amortization |
|
|
103 |
|
|
|
305 |
|
Travel |
|
|
33 |
|
|
|
105 |
|
Other activities |
|
|
277 |
|
|
|
215 |
|
|
|
$ |
5,513 |
|
|
$ |
5,469 |
|
Other Income: Other income was $0.1 million for the six months ended June 30, 2026, primarily consisting of interest earned on money market funds. Other income for the six months ended June 30, 2025, was $0.5 million, primarily consisting of $250,000 received as a recipient of a Milestone 1 Award in the XPRIZE Healthspan competition and $0.2 million of interest earned on money market funds.
Net Loss: Net loss was $10.8 million for the six months ended June 30, 2026, compared to $10.0 million for the six months ended June 30, 2025. The increase of $0.8 million, or 8%, was due to the factors outlined above.
Cash Flows
The following table summarizes our sources and uses of cash for the period presented (in thousands):
|
|
Six Months Ended |
|
|||||
|
|
2026 |
|
|
2025 |
|
||
Net cash used in operating activities |
|
$ |
(10,023 |
) |
|
$ |
(8,294 |
) |
Net cash used in investing activities |
|
|
(123 |
) |
|
|
(413 |
) |
Net cash provided by (used in) financing activities |
|
|
15,562 |
|
|
|
(191 |
) |
Change in cash and cash equivalents |
|
$ |
5,416 |
|
|
$ |
(8,898 |
) |
35
Operating Activities. We have incurred losses since inception. Net cash used in operating activities for the six months ended June 30, 2026 was $10.0 million, consisting primarily of our net loss of $10.8 million, payments of $0.3 million in prepaid expenses and other assets, and $0.3 million in other liabilities. This was partially offset by non-cash expenses of $0.8 million for equity-based compensation expenses, $0.5 million for depreciation and amortization and $0.3 million for accounts payable and accrued expenses. Net cash used in operating activities for the six months ended June 30, 2025 was $8.3 million, consisting primarily of our net loss of $10.0 million and payments of $0.6 million in prepaid expenses and other assets. This was partially offset by non-cash expenses of $0.9 million for equity-based compensation, $0.7 million for depreciation and amortization, and $0.8 million for accounts payable and accrued expenses.
Investing Activities. Net cash used in investing activities consisted of purchases of property and equipment and intangible assets of $0.1 million and $0.4 million for the six months ended June 30, 2026 and 2025, respectively.
Financing Activities. Net cash provided by financing activities for the six months ended June 30, 2026 was $15.6 million and consisted primarily of $13.5 million of net proceeds from the issuance of stock in the March 2026 Private Placement financing and the ATM facility as well as $1.4 million from the exercise of warrants. The Company also received approximately $0.9 million in cash from a sale to the investors in the Private Placement of an interest in 50% of the future proceeds from the potential future sale of a Rare Pediatric Disease Priority Review Voucher to the extent received from the U.S. FDA in connection with the Company's laromestrocel program for HLHS. Net cash used in financing activities for the six months ended June 30, 2025 was less than $0.2 million for the payment of taxes upon vesting of RSUs.
LIQUIDITY, CAPITAL RESOURCES, AND GOING CONCERN
We have incurred recurring losses and negative cash flows from operations since inception. We expect to incur significant expenses and operating losses as we advance the preclinical and clinical development of our programs. We expect that our sales, research and development and general and administrative costs will remain substantial in connection with conducting additional preclinical studies and clinical trials for our current and future programs and investigational product candidates, contracting with CROs to support preclinical studies and clinical trials, expanding our intellectual property portfolio, and providing general and administrative support for our operations. As a result, we will need additional capital to fund our operations, which we may obtain from additional equity or debt financings, collaborations, licensing arrangements, or other sources.
To date, we have financed our operations primarily through our IPO, registered and private placement equity financings, grant awards, fees generated from The Bahamas Registry Trial and contract manufacturing services. Since we were formed, we have raised approximately $136.0 million in gross proceeds from the issuance of equity, including $15.9 million in gross proceeds from the Private Placement in March 2026. At June 30, 2026, we had cash and cash equivalents of $10.1 million and working capital of $7.0 million.
We currently anticipate our existing cash and cash equivalents will enable us to fund our operating expenses and capital expenditure requirements into the fourth quarter of 2026, based on our current operating budget and cash flow forecast. Our operating costs will continue to be substantial for the foreseeable future in connection with our ongoing activities. In past years we have been able to fund a large portion of our clinical programs with the use of grant funding.
Specifically, we will incur expenses to:
36
We intend to seek additional financing opportunities, capital raises, as well as non-dilutive funding options to support our operating plans. Additionally, following a positive Type B meeting with the FDA in March 2025 with respect to the Alzheimer's disease (AD) regulatory pathway, we are focused on seeking partnership opportunities and/or non-dilutive funding for the AD program, including a proposed single, seamless adaptive Phase 2/3 clinical trial. There can be no assurance we will be able to attain future financing at terms favorable to us or at all. In the event we are unable to attain the financing needed, we will need to materially revise our current operational plan. We do not have sufficient cash to meet our minimum expenditure commitments for one year from the date these unaudited condensed financial statements are available to be issued, and therefore we need to raise additional funds to continue as a going concern. As a result, there is substantial doubt about our ability to continue as a going concern.
Capital Raising Efforts
As of June 30, 2026, we have sold 28,230,871 shares of Class A common stock and 11,873.04 shares of Series A preferred stock through our IPO and subsequent follow-on public and private equity offerings and transactions. Additionally, as of June 30, 2026, warrants exercisable for an aggregate of up to 21,238,731 shares of our Class A common stock remain outstanding at exercise prices ranging from $0.65 per share to $175.00 per share.
ATM Agreement
Pursuant to an agreement with Wainwright dated September 19, 2025 (as amended, the “ATM Agreement”), the Company also has access to an At-The-Market (ATM) equity financing vehicle, providing for the sale and issuance by the Company of shares of Class A common stock from time to time, through or to Wainwright as the Company’s sales agent or principal. The gross sales price of the shares of Class A common stock sold by Wainwright under the ATM Agreement as sales agent shall be the market price for the shares of Class A common stock on Nasdaq at the time of sale. The aggregate market value of the shares of Class A common stock eligible for sale under the ATM prospectus supplement is currently $10.7 million. However, the ATM facility is under a standstill restriction until June 9, 2026, and thereafter we have restrictions in place regarding our ability to use the ATM facility unless our Class A common stock is trading above $0.80 per share until September 7, 2026.
During the three months ended June 30, 2026, we sold 120,689 shares of Class A common stock under the ATM Agreement at a weighted average share price of $0.83 per share, resulting in net proceeds of approximately $42,000 to the Company after deducting certain offering expenses, including approximately $7,100 in compensation to Wainwright. As of June 30, 2026, an aggregate market value of approximately $9.3 million of shares of Class A common stock remains available for future sale under the ATM prospectus supplement.
The Company has no obligation to sell any shares of Class A common stock under the ATM Agreement and the Company or Wainwright may at any time suspend offers under the ATM Agreement, pursuant to the terms therein. Wainwright is not obligated to purchase any shares of Class A common stock on a principal basis pursuant to the ATM Agreement, except as otherwise specifically agreed by Wainwright and the Company in a separate agreement. No assurance can be given that the Company will sell any additional shares of Class A common stock under the ATM Agreement, or if such sales occur, no assurance can be given as to the price or number of shares that will be sold, or the dates on which any such sales will take place.
The ATM offering will terminate upon the earlier of (i) the sale of the Company’s Class A common stock pursuant to the ATM prospectus supplement having an aggregate sales price of $10.7 million or (ii) termination of the ATM Agreement by the Company or Wainwright as permitted therein.
Private Placement Transaction
On March 10, 2026, the Company entered into a Securities Purchase Agreement with certain institutional and accredited investors providing for a private placement of Class A common stock, Series A preferred stock and certain related rights in up to two closings (the "Private Placement"). The initial closing occurred on March 11, 2026 and resulted in gross proceeds of approximately $15.9 million, before deducting placement agent fees and other offering expenses. Additional information regarding the Private Placement, including the securities issued, the related interest in potential proceeds from the sale of a Rare Pediatric Disease Priority Review Voucher ("PRV"), the placement agent warrants and compensation arrangements, and the terms of the Series A preferred stock, is included in the Company's Quarterly Report on Form 10-Q for the quarter ended March 31, 2026.
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Pursuant to the Purchase Agreement, subject to the satisfaction or waiver of specified closing conditions, the Company may complete a second closing for additional gross proceeds of approximately $15.0 million, before deducting placement agent fees and other offering expenses. The second closing is contingent upon the achievement (or waiver) of certain clinical and market-based milestones, as set forth in the Purchase Agreement, including specified Phase 2b HLHS study results and a minimum trading price and volume threshold. Investors holding a majority in interest of the Private Placement Securities may waive these conditions and elect to proceed with the second closing.
Grant Awards
Since 2016 through June 30, 2026, we have been directly awarded approximately $11.5 million in governmental and non-profit association grants, which have been used to fund our clinical trials, research and development, production and overhead. Grant awards are recognized as revenue, and depending on the funding mechanism, are deposited directly in our accounts as lump sums, which are staggered over a predetermined period or drawn down from a federal payment management system account for reimbursement of expenses incurred. Revenue recognition occurs when the grant-related expenses are incurred or supplies and materials are received. We have had no grant revenue since 2023. As of June 30, 2026 and December 31, 2025, we had no unused grant funds available for us to draw.
Terms and Conditions of Grant Awards
Governmental grant projects are typically divided into periods (e.g., a three-year grant may have three one-year periods), and the total amount awarded is divided according to the number of periods. At pre-specified time points, which are detailed in the grant award notifications, we are required to submit interim financial and scientific reports to the granting agency totaling funds spent, and in some cases, detailing use of proceeds and progress made during the reporting period. After funding the initial period, receipt of additional grant funds is contingent upon satisfactory submission of our interim reports to the granting agency.
In addition to governmental grants, the Company also receives awards from non-profit foundations through competitive application processes, where funding is typically distributed in stages as specific milestones are met.
Grant awards arise from submitting detailed research proposals to granting agencies and other organizations and winning a highly competitive and rigorous application review and process that is judged on the merits of the proposal. There are typically multiple applicants applying and competing for a finite amount of funds. As such we cannot be sure that we will be awarded grant funds in the future despite our past success in receiving such awards.
Funding Requirements
Because of the numerous risks and uncertainties associated with research, development and commercialization of our investigational product candidates, it is difficult to estimate with certainty the amount of our working capital requirements. Our future funding requirements will depend on many factors, including:
Further, our operating results may change in the future, and we may need additional funds to meet operational needs and capital requirements associated with such operating plans. Until such time, if ever, that we can generate product revenue sufficient to achieve profitability, we expect to finance our cash needs through a combination of equity offerings, debt financings, grant awards, collaboration agreements, other third-party funding, strategic alliances, licensing arrangements and marketing and distribution arrangements.
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We currently have no credit facility or committed sources of capital. Debt financing and additional preferred equity financing, if available, may involve agreements that include covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making capital expenditures or declaring dividends. If we raise additional funds through other third-party funding, collaboration agreements, strategic alliances, licensing arrangements or marketing and distribution arrangements, we may have to relinquish valuable rights to our technologies, future revenue streams, research programs or investigational product candidates or grant licenses on terms that may not be favorable to us. If we are unable to raise additional funds through equity or debt financings when needed, we may be required to delay, limit, reduce or terminate our biologic drug development or future commercialization efforts or grant rights to develop and market products or investigational product candidates that we would otherwise prefer to develop and market ourselves.
In order to meet our operational goals, we will need to obtain additional capital, which we will likely obtain through a variety of means, including through public or private equity, debt financings or other sources, including up-front payments and milestone payments from strategic collaborations. To the extent that we raise additional capital through the sale of convertible debt or equity securities, current stockholder ownership interest will be diluted, and the terms may include liquidation or other preferences that adversely affect stockholder rights. Such financing will likely result in dilution to stockholders, and may result in imposition of debt covenants, increased fixed payment obligations or other restrictions that may affect our business. If we raise additional funds through up-front payments or milestone payments pursuant to strategic collaborations with third parties, we may have to relinquish valuable rights to our investigational product candidates or grant licenses on terms that are not favorable to us. In addition, we may seek additional capital due to favorable market conditions or strategic considerations even if we believe we have sufficient funds for our current or future operating plans.
Contractual Obligations and Commitments
As of June 30, 2026, we have $0.6 million in operating lease obligations and no CRO payment obligations. From time-to-time we may enter into contracts in the normal course of business with third-party contract organizations for clinical trials, preclinical studies, manufacturing and other services and products for operating purposes. These contracts generally provide for termination following a certain period after notice and therefore we believe that our non-cancelable obligations under these agreements are not material.
We have not included milestone or royalty payments or other contractual payment obligations if the timing and amount of such obligations are unknown or uncertain.
Critical Accounting Estimates
For a discussion of our critical accounting estimates, refer to “Management’s Discussion and Analysis of Results of Operations and Financial Condition” in Part II, Item 7 and the notes to our financial statements in Part II, Item 8 of our 2025 Form 10-K. See also Note 2 to the unaudited condensed financial statements. There have been no material changes to our critical accounting estimates from those disclosed in our 2025 Form 10-K.
Emerging Growth Company Status
We are an “emerging growth company,” as defined in the Jumpstart Our Business Startups Act, or JOBS Act, which is a law intended to encourage funding of small businesses in the U.S. by easing many of the country’s securities regulations, and we may take advantage of reduced reporting requirements that are otherwise applicable to public companies. Section 107 of the JOBS Act exempts emerging growth companies from being required to comply with new or revised financial accounting standards until private companies are required to comply with those standards. We have elected to take advantage of the extended transition period for complying with new or revised accounting standards; and as a result of this election, our financial statements may not be comparable to companies that comply with public company effective dates. The JOBS Act also exempts us from having to provide an auditor attestation of internal control over financial reporting under Sarbanes-Oxley Act Section 404(b).
We will remain an “emerging growth company” until the earliest of (1) the last day of the fiscal year in which we have total annual gross revenues of $1.235 billion or more, (2) the last day of the fiscal year following the fifth anniversary of the completion of our IPO (i.e. December 31, 2026), (3) the date on which we have issued more than $1.0 billion in nonconvertible debt during the previous three years or (4) the date on which we are deemed to be a large accelerated filer under the rules of the SEC, which generally is when a company has more than $700 million in market value of its reported class of stock held by non-affiliates and has been a public company for at least 12 months and have filed at least one Annual Report on Form 10-K.
39
Recent Accounting Pronouncements
A description of recent accounting pronouncements that may potentially impact our financial position, results of operations or cash flows is disclosed in Note 2 to our unaudited condensed financial statements included in Item 1 of this 10-Q.
Item 3. Quantitative and Qualitative Disclosures About Market Risk.
There have been no material changes in our exposure to market risks from those disclosed in Management’s Discussion and Analysis of Financial Condition and Results of Operations in our 2025 Form 10-K.
Item 4. Controls and Procedures.
Disclosure controls and procedures
Our management, under the supervision of and with the participation of our Chief Executive Officer and our Chief Financial Officer, has evaluated the effectiveness of our disclosure controls and procedures, as defined in Rules 13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934, as amended as of the end of the period covered by this Quarterly Report on Form 10-Q. Based upon this evaluation, our Chief Executive Officer and Chief Financial Officer have concluded that, as of the end of the period covered by this Quarterly Report on Form 10-Q, our disclosure controls and procedures were effective.
Changes in internal control over financial reporting
There were no changes in our internal control over financial reporting identified in connection with the evaluation of such internal control over financial reporting required by Rule 13a-15(d) and Rule 15d-15(d) of the Exchange Act that occurred during the fiscal quarter ended June 30, 2026 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.
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PART II. OTHER INFORMATION
Item 1. Legal Proceedings
From time to time, the Company could become involved in disputes and various litigation matters that arise in the normal course of business. These may include disputes and lawsuits related to intellectual property, licensing, contract law and employee relations matters. While management does not currently believe that the ultimate disposition of these matters will have a material adverse impact on the Company’s results of operations, cash flows, or financial position, litigation is inherently unpredictable and depending on the nature and timing of these proceedings, an unfavorable resolution could materially affect the Company’s future results of operations, cash flows or financial condition in a particular period. As of June 30, 2026, the Company is not aware of any legal proceedings or material developments requiring disclosure.
Item 1A. Risk Factors.
Except with respect to the items noted below, there have been no material changes to the risk factors affecting the Company from those disclosed in the 2025 Form 10-K.
We will need to raise substantial additional funding. If we are unable to raise capital when needed, we could be forced to delay, scale back or discontinue some of our therapeutic candidate development programs or commercialization efforts.
The development of pharmaceutical drugs is capital intensive. We are currently advancing laromestrocel into clinical development. As a result of the recently completed Private Placement transaction, and based on current operating plans, we expect that our cash and cash equivalents as of June 30, 2026 of $10.1 million, which include proceeds from the Private Placement will be adequate to fund operations into the fourth quarter of 2026. The Company also has access to an At-The-Market (ATM) equity financing vehicle for the sale of up to $10.7 million aggregate market value of shares of the Company’s Class A common stock; however, the ATM facility was under a standstill restriction until June 9, 2026, and thereafter we have restrictions in place regarding our ability to use the ATM facility unless our Class A common stock is trading above $0.80 per share until September 7, 2026. We will require additional funds to advance further. If we are capital constrained, we may not be able to meet our obligations. If we are unable to meet our obligations, or we experience a disruption in our cash flows, it could limit or halt our ability to continue to develop our current investigational product candidate or even to continue operations, either of which occurrence would have a material adverse effect on us.
We expect our expenses to continue to increase in connection with our ongoing activities, particularly as we continue the research and development of, advance the preclinical and clinical activities of, and seek marketing approval for, our current investigational product candidate. In 2025, the Company began ramping up Biologics License Application (“BLA”) enabling activities, with a focus on clinical spend supporting HLHS study completion and delivering top-line results. If the current ELPIS II trial in HLHS is successful, and the trial results and other available evidence are deemed sufficient by the FDA to support filing a BLA following the readout of top-line results of the ELPIS II data, then we would intend to pursue a potential BLA filing with the FDA and a commercialization partner. Additionally, following a productive Type B meeting with the FDA in March 2025 with respect to the AD regulatory pathway, we are focused on seeking partnership opportunities and/or non-dilutive funding for the AD program, including a proposed single, seamless adaptive Phase 2/3 clinical trial. The Company expects that its current operating plan will require increased spending and additional capital investments to support these initiatives, and intends to seek additional financing through capital raises, non-dilutive funding options, and commercial partnering across all indications. There can be no assurance the Company will be able to attain future financing at terms favorable to the Company or at all. In the event the Company is unable to attain the financing needed, it will need to materially revise its current operational plan. The Company may need to adjust its current and future spending levels if needed based on the level of cash available.
In addition, if we obtain marketing approval for any of our current or future investigational product candidates, we expect to incur significant commercialization expenses related to sales, marketing, manufacturing and distribution. We may also need to raise additional funds sooner if we choose to pursue additional indications and/or geographies for our current investigational product candidates or otherwise expand more rapidly than we presently anticipate. Furthermore, we expect to continue to incur significant costs associated with operating as a public company. If we are unable to raise capital when needed, we could be forced to delay, scale back or discontinue the development and commercialization of one or more of our investigational product candidates, delay our pursuit of potential licenses or acquisitions, or significantly reduce or cease our operations.
As a result of the recently completed Private Placement financing discussed in “Capital Raising Efforts” in the LIQUIDITY, CAPITAL RESOURCES, AND GOING CONCERN section of this 10-Q, and based on current operating plans, we expect that our current cash and cash equivalents will be adequate to fund operations into the fourth quarter of 2026. In past years, we have been able to fund a large portion of our clinical programs with the use of grant funding. Our future capital requirements will depend on and could increase significantly as a result of many factors, including:
41
Identifying potential current or future investigational product candidates and conducting preclinical testing and clinical trials is a time-consuming, expensive and uncertain process that takes years to complete, and we may never generate the necessary data or results required to obtain marketing approval and achieve drug sales.
In addition, our current or future investigational product candidates, if approved, may not achieve commercial success. Our commercial revenues, if any, will be derived from sales of drugs that we do not expect to be commercially available for many years, if ever. Accordingly, we will need to continue to rely on additional funding to achieve our business objectives.
Any additional fundraising efforts may divert our management from their day-to-day activities, which may adversely affect our ability to develop and commercialize our current or future investigational product candidates.
Disruptions in the financial markets in general have made equity and debt financing more difficult to obtain and may have a material adverse effect on our ability to meet our fundraising needs. We cannot guarantee that future financing will be available in sufficient amounts or on terms favorable to us, if at all. Moreover, the terms of any financing may adversely affect the holdings or the rights of our stockholders and the issuance of additional securities, whether equity or debt, by us, or the possibility of such issuance, may cause the market price of our Class A common stock to decline. The sale of additional equity or convertible securities would dilute all of our stockholders. The incurrence of indebtedness could result in fixed payment obligations, and we may be required to agree to certain restrictive covenants, such as limitations on our ability to incur additional debt, limitations on our ability to acquire, sell or license intellectual property rights and other operating restrictions that could adversely impact our ability to conduct our business. We could also be required to seek funds through arrangements with collaborators or otherwise at an earlier stage than otherwise would be desirable and we may be required to relinquish rights to some of our technologies or current or future investigational product candidates or otherwise agree to terms unfavorable to us, any of which may have a material adverse effect on our business, operating results and prospects.
If we are unable to obtain funding on a timely basis, we may be required to significantly delay, scale back or discontinue one or more of our research or development programs, activities to prepare for a potential BLA filing, including CMC and manufacturing readiness, or the commercialization of any investigational product candidates or be unable to expand our operations or otherwise capitalize on our business opportunities, as desired, which could materially affect our business, financial condition and results of operations.
If we continue to fail to meet the requirements for continued listing on Nasdaq, our Class A common stock could be delisted from trading on Nasdaq, which would likely reduce the liquidity of our Class A common stock and could cause our trading price to decline.
Minimum Bid Price Requirement
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Our Class A common stock is currently listed for quotation on the Nasdaq Capital Market. We are required to meet listing requirements in order to maintain our listing on Nasdaq. We could lose our listing on Nasdaq if the closing bid price of our Class A common stock does not increase or if in the future, we fail to meet any of the other Nasdaq listing requirements. The loss of our Nasdaq listing would in all likelihood make our Class A common stock significantly less liquid and adversely affect its value.
On September 22, 2025, we received a notice from the Listing Qualifications Department of Nasdaq that our Class A common stock did not meet the $1.00 minimum bid price requirement for continued listing on The Nasdaq Capital Market pursuant to Nasdaq Listing Rule 5550(a)(2) (the “Minimum Bid Price Requirement”) as a result of the closing bid price of the Company’s Class A common stock for the last 30 consecutive business days. The notice does not result in the immediate delisting of the Company’s Class A common stock and, pursuant to Nasdaq Listing Rule 5810(c)(3)(A), the Company had an initial period of 180 calendar days, or until March 23, 2026 to regain compliance with the Minimum Bid Price Requirement. On March 24, 2026, following submission of a request by the Company, the Company received written notice from Nasdaq granting a second compliance period of an additional 180 calendar days, or until September 21, 2026 (the “Compliance Date”), to regain compliance with the Minimum Bid Price Requirement, as permitted pursuant to Nasdaq Listing Rule 5810(c)(3)(A)(ii), due to the Company’s satisfaction of the continued listing requirements for the market value of publicly held shares and all other initial listing standards for the Nasdaq Capital Market, with the exception of the Minimum Bid Price Requirement, as well as its intention to cure the deficiency during the additional compliance period.
If, at any time before the Compliance Date, the bid price closes at $1.00 or more per share for a minimum of ten consecutive business days (subject to Nasdaq’s discretion to increase the minimum period to up to 20 consecutive business days pursuant to Nasdaq Listing Rule 5810(c)(3)(H)), Nasdaq would provide written notification to the Company that it again complies with the Minimum Bid Price Requirement and the Class A common stock will continue to be eligible for listing on The Nasdaq Capital Market unless other eligibility deficiencies exist. On April 15, 2026, the Listing Qualifications Department of Nasdaq opted to exercise its discretion to increase the minimum period pursuant to Nasdaq Listing Rule 5810(c)(3)(H). However, pursuant to Nasdaq Listing Rule 5810(c)(3)(A)(iii), if the Company’s Class A common stock has a closing bid price of $0.10 or less for ten consecutive trading days before the Compliance Date, Nasdaq can issue a Staff Determination Letter, which, unless appealed, would subject our Class A common stock to immediate suspension and delisting.
If the Company does not regain compliance with the Minimum Bid Price Requirement by the Compliance Date, Nasdaq will begin delisting procedures. In the event of a delisting from the Nasdaq Capital Market, our Class A common stock would likely be traded in the over-the- counter inter-dealer quotation system, more commonly known as the OTC. OTC transactions involve risks in addition to those associated with transactions in securities traded on the securities exchanges, such as the Nasdaq Capital Market, or Exchange-listed stocks. Many OTC stocks trade less frequently and in smaller volumes than Exchange-listed stocks. Accordingly, our Class A common stock would be less liquid than it would be otherwise. Also, the prices of OTC stocks are often more volatile than Exchange-listed stocks. Additionally, many institutional investors are prohibited from investing in OTC stocks, and it might be more challenging to raise capital when needed.
The Company intends to monitor the closing bid price of the Class A common stock and assess its available options to regain compliance with the Minimum Bid Price Requirement, if necessary, and continue listing on The Nasdaq Capital Market. There can be no assurance that the Company will be able to regain compliance with the Minimum Bid Price Requirement or will otherwise be in compliance with other applicable Nasdaq listing rules. If among such options the Company elects to pursue a reverse stock split to regain compliance with the Minimum Bid Price requirement, there can be no assurance that it would accomplish this objective for any meaningful period of time, or at all, or that it would result in any permanent or sustained increase in the market price of our Class A common stock; and if such an event would be viewed unfavorably by the market, it could have the effect of reducing our market capitalization. Furthermore, pursuant to a recent modification to Nasdaq’s listing standards, if a company effects a reverse stock split and within one year thereafter becomes non-compliant with the Minimum Bid Price Requirement, it would immediately receive a notification letter from the Nasdaq Listing Qualifications Department commencing delisting proceedings, with no opportunity for a compliance period.
Audit Committee Composition
On March 4, 2026, we notified Nasdaq that, as a result of the March 3, 2026 resignation of Mr. Richard Kender as a member of the Board and as chairman of the Audit Committee, we are temporarily no longer in compliance with Nasdaq Listing Rule 5605(c)(2)(A), which requires that the audit committee of a listed company be composed of at least three independent directors and that at least one member meets the financial sophistication requirements.
Following the election of three new members of the Board at the Company’s annual meeting of stockholders held on July 1, 2026, the Board approved the reconstitution of the Audit Committee to consist of Ms. Leah Rush Cann (Chair), Dr. Deborah Ascheim, Dr. George Paletta and Ms. Ursula Ungaro. Each such member of the Audit Committee qualifies as independent, and Ms. Cann further
43
qualifies as an audit committee financial expert under Item 407(d)(5)(ii) of Regulation S-K promulgated under the Securities Act of 1933, as amended, and she meets the financial sophistication requirements under Nasdaq Listing Rule 5605(c)(2)(A).
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds.
ISSUER PURCHASES OF EQUITY SECURITIES
Period |
|
Total |
|
|
Average |
|
|
Total |
|
|
Maximum Number (or Approximate Dollar Value) of |
|
||||
April 1-30, 2026 |
|
|
— |
|
|
$ |
— |
|
|
|
— |
|
|
|
— |
|
May 1-31, 2026 |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
June 1-30, 2026 |
|
|
56,225 |
|
|
|
1.12 |
|
|
|
— |
|
|
|
— |
|
Total |
|
|
56,225 |
|
|
$ |
1.12 |
|
|
|
— |
|
|
|
— |
|
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Item 3. Defaults Upon Senior Securities
None.
Item 4. Mine Safety Disclosures
Not applicable.
Item 5. Other Information
Trading Arrangements
None of the Company’s directors or “officers,” as defined in Rule 16a-1(f) of the Exchange Act,
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Item 6. Exhibits.
Exhibit No. |
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Description |
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|
|
||
3.1 |
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3.2 |
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3.3 |
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||
3.4 |
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3.5 |
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||
4.1 |
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||
10.1# |
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Letter Agreement between Longeveron Inc. and Marie Washburn dated June 30, 2026, filed herewith |
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10.22.1 |
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10.23.1^ |
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10.31.1# |
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||
31.1 |
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31.2 |
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32.1 |
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||
101.INS |
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Inline XBRL Instance Document - the instance document does not appear in the Interactive Data File as its XBRL tags are embedded within the Inline XBRL Document |
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101.SCH |
|
Inline XBRL Taxonomy Extension Schema With Embedded Linkbase Documents |
|
104 |
|
Inline Cover Page Interactive Data File (formatted as Inline XBRL and contained in Exhibit 101) |
|
^ Certain schedules and exhibits have been omitted pursuant to Item 601(a)(5) of Regulation S-K. The Company hereby undertakes to furnish copies of any of the omitted schedules or exhibits upon request by the SEC.
# Indicates management contract or compensatory plan.
46
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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LONGEVERON INC. |
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Date: August 12, 2026 |
/s/ Stephen H. Willard |
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Stephen H. Willard |
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Chief Executive Officer |
|
(principal executive officer) |
Date: August 12, 2026 |
/s/ Marie Washburn |
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Marie Washburn |
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Senior Vice President and Chief Financial Officer |
|
(principal financial officer and principal accounting officer) |
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Exhibit 10.1#
June 30th, 2026
Dear Marie:
This letter agreement (this “Agreement”) sets forth the terms and conditions of your (referred to as “you” or “your” or “executive”) employment with Longeveron Inc. (the “Company”), which shall be effective as of July 13, 2026 (the “Effective Date”). This Agreement will govern your employment with the Company following the Effective Date on the following terms and conditions:
1
2
“Cause” shall include, but not be limited to: (i) the executive’s unauthorized use or disclosure of confidential information or trade secrets of the Company or any subsidiary, or any material breach of a written agreement between the executive and the Company or any of its subsidiaries, including without limitation a material breach of any employment, confidentiality, non-compete, non-solicit or similar agreement; (ii) the executive’s commission of, indictment for or the entry of a plea of guilty or nolo contendere by the executive to, a felony under the laws of the United States or any state thereof or any crime involving dishonesty or moral turpitude (or any similar crime in any jurisdiction outside the United States); (iii) the executive’s gross negligence or willful misconduct which is materially injurious to the Company or any of its subsidiaries, or the executive’s willful or repeated failure or refusal to substantially perform
3
material assigned duties; (iv) any act of fraud, embezzlement, material misappropriation or dishonesty committed by the executive against the Company or any of its subsidiaries; (v) the material violation by the executive of any rule or policy of the Company or any of its subsidiaries of which the executive had written notice; or (v) any acts, omissions or statements by executive which the Company reasonably determines to be materially detrimental or damaging to the reputation, operations, prospects or business relations of the Company or any subsidiary; provided further that for any “Cause” reasonably capable of cure, “Cause” shall not exist unless Company has provided executive with written notice of the “Cause,” and executive fails to cure the events or issues giving rise to the “Cause” within thirty (30) days of Company’s notice.
“Good Reason” means (i) a change in the executive’s position with the Company that materially reduces the executive’s title, authority, duties or responsibilities or the level of management to which he or she reports, (ii) a material change in executive’s Place of Duty, or material diminution in the executive’s level of compensation (including base salary, fringe benefits and target bonuses under any corporate performance-based incentive programs), excluding any reduction that applies generally to similarly situated employees of the Company, and excluding any change made in connection with the termination of your employment for Cause, or on account of your death or Disability, or temporarily as a result of your Disability or other absence for an extended period, provided, that you will not have the right to resign for Good Reason pursuant to this provision of the Good Reason definition due to a change in authority, duties or responsibilities solely as a result of the Company no longer being a publicly traded company; and provided further that for any “Good Reason” reasonably capable of cure, “Good Reason” shall not exist unless executive has provided Company with written notice of the “Good Reason,” and Company fails to cure the events or issues giving rise to the “Good Reason” within thirty (30) days of executive’s notice.
4
All references in this Agreement to your termination of employment shall mean your “separation from service” within the meaning of Section 409A of the Code and Treas. Reg. § 1.409A-1(h). Whether you have
had a separation from service will be determined based on all of the facts and circumstances and in accordance with the guidance issued under Section 409A.
Notwithstanding any other provision of this Agreement to the contrary, if any payment or benefit provided to you in connection with your termination of employment is determined to constitute "nonqualified deferred compensation" within the meaning of Section 409A and you are determined by the Company to be a "specified employee" as defined in Section 409A(a)(2)(b)(i), then such payment or benefit shall not be paid until the first payroll date following the six-month anniversary of your termination date or, if earlier, on your death (the "Delayed Payment Date"). The aggregate of any payments that would otherwise have been paid before the Delayed Payment Date shall be paid (without interest) to you (or your estate or beneficiaries) in a lump sum on the Delayed Payment Date and thereafter, any remaining payments shall be paid without delay in accordance with their original schedule.
With respect to any taxable expense reimbursements, in-kind benefits and/or cash allowances provided or paid by the Company under this Agreement, such reimbursement shall be made in accordance with and subject to the following terms and conditions: (i) reimbursements shall only be made to the extent that the expense was actually incurred and reasonably substantiated; (ii) reimbursements of eligible expenses shall be made on or before the last day of your taxable year following the taxable year in which you incurred the expense; (iii) the amount of any expenses eligible for reimbursement or the amount of any in-kind benefits provided, as the case may be, under this Agreement during any calendar year shall not affect the amount of expenses eligible for reimbursement or the amount of any in-kind benefits provided during any other calendar year; and (iv) the right to reimbursement or to any in-kind benefit pursuant to this Agreement shall not be subject to liquidation or exchange for any other benefit.
Notwithstanding any provision of this Agreement to the contrary, you acknowledge and agree that the Company and its employees, officers, directors and affiliates are not providing you with any tax advice with respect to Section 409A of the Code or otherwise and are not making any guarantees or other assurances of any kind to you with respect to the tax consequences or treatment of any amounts paid or payable to you under this Agreement. Nothing provided or contained in this Agreement will be construed to obligate or cause the
Company and/or its employees, officers, directors, subsidiaries and affiliates to be liable for, any tax, interest or penalties imposed on you related to or arising with respect to any violation of Section 409A.
Unless the Company and you otherwise agree, any determination required under section shall be made in writing in good faith by the Company’s independent accounting firm or such other nationally or regionally recognized accounting firm selected by the Company (the “Accountants”), whose determination shall be conclusive and binding upon you and the Company for all purposes. In the event that a reduction to the Benefits under this section, the reduction shall apply first to the Benefits that are not deferred compensation subject to Section 409A of the Code and you shall be given the choice, subject to approval by the Company, of which of such Benefits to reduce; provided, that such reduction achieves the result specified in clause (ii) above of this
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section. If a reduction in the Benefits that are subject to Section 409A of the Code is required, such Benefits shall be reduced pro rata, but with no change in the time at which such Benefits shall be paid. For purposes of making the calculations required by this section, the Accountants may make reasonable assumptions and approximations concerning applicable taxes and may rely on reasonable, good faith interpretations concerning the application of the Code. The Company and you shall furnish to the Accountants such information and documents as the Accountants may reasonably request in order to make a determination under this section. The Company shall bear all costs the Accountants may reasonably incur in connection with any calculations contemplated by this section.
EACH OF THE PARTIES HERETO HEREBY IRREVOCABLY WAIVES ANY AND ALL RIGHTS TO TRIAL BY JURY IN ANY LEGAL PROCEEDING ARISING OUT OF OR RELATED TO THIS AGREEMENT OR THE TRANSACTIONS CONTEMPLATED HEREBY.
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[Signature page follows]
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Please sign and date this Agreement in the space indicated and return it to my attention to evidence your understanding and acceptance of the terms set forth herein.
Sincerely, |
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Longeveron Inc. |
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By: |
/s/Stephen Willard |
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Stephen Willard, CEO |
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Agreed to and Accepted: |
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By: |
/s/Marie Washburn |
Marie Washburn |
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Exhibit 10.22.1
LONGEVERON INC.
AMENDMENT NO. 1 TO AT THE MARKET OFFERING AGREEMENT
June 16, 2026
H.C. Wainwright & Co., LLC
430 Park Avenue
New York, NY 10022 Ladies and Gentlemen:
Reference is made to the At the Market Offering Agreement, dated September 19, 2025 (the “Sales Agreement”), by and between Longeveron Inc., a Delaware corporation (the “Company”), and H.C. Wainwright & Co., LLC (the “Manager”). Capitalized terms used herein but not otherwise defined are used herein as defined in the Sales Agreement.
The Company and the Manager (collectively, the “Parties”) wish to amend the Agreement, to be effective as of the date hereof, pursuant to Section 14 of the Sales Agreement, on the terms and conditions set forth in this letter (this “Amendment”). Therefore, for and in consideration of the mutual covenants and agreements herein contained, and contained in the Sales Agreement, the Company, on the one hand, and the Manager, on the other hand, the Parties therefore hereby agree as follows:
“Except as set forth in the SEC Reports, the Company has not been informed by the FDA that the FDA will prohibit the marketing, sale, license or use in the United States of any product proposed to be developed, produced or marketed by the Company. Except as set forth in the SEC Reports, the FDA has not expressed any concern in writing as to approving or clearing for marketing any product being developed or proposed to be developed by the Company, except as would not, individually or in the aggregate, reasonably be expected to result in a Material Adverse Effect.”
(Signature page follows.)
Exhibit 10.22.1
If the foregoing is in accordance with your understanding of our agreement, please sign and return to the Company a counterpart hereof; whereupon this instrument, along with all counterparts, will become a binding agreement by the Company and the Manager in accordance with its terms.
Very trulyyours, |
LONGEVERON INC. |
By: |
Name: Stephen H. Willard |
Title: Chief Executive Officer |
The foregoing Amendment No. 1 to the Sales Agreement is hereby confirmed and accepted as of the datefirst written above. |
H.C. WAINWRIGHT & CO., LLC |
By: /s/ Merav Gershtenman |
Name: Merav Gershtenman Title: Chief Legal Officer |
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Exhibit 10.23.1^
AMENDMENT NO. 1 TO PURCHASE AGREEMENT
AMENDMENT NO. 1 TO PURCHASE AGREEMENT, dated as of May 20, 2026 (this “Amendment”), by and among LONGEVERON INC., a Delaware corporation (the “Company”), and each of the entities (each, an “Investor” and together, the “Investors”) listed on Exhibit A attached to that certain Purchase Agreement, dated as of March 10, 2026, by and among the Company and the Investors (the “Purchase Agreement”). Capitalized terms used and not otherwise defined herein have the meanings ascribed thereto in the Purchase Agreement.
RECITALS
A. The Company and the Investors entered into the Purchase Agreement, pursuant to which, among other things, the Company agreed to sell, and the Investors agreed to purchase, certain Securities and the PRV Interest on the terms and conditions set forth therein.
B. The Company and the Investors desire to amend the Purchase Agreement in order to, among other things, clarify the Investors’ rights and interests with respect to the PRV Interest in connection with a potential transfer of the Company’s laromestrocel program for Hypoplastic Left Heart Syndrome.
C. Pursuant to Section 10.15 of the Purchase Agreement, the Purchase Agreement may be amended by the written consent of the Company and the Investors of at least a majority in interest of the Securities then held by the Investors (determined as if all of the Preferred Shares then outstanding have been converted without regard to any limitations on the conversion of such Preferred Shares), and the requisite Investors have consented to this amendment and restatement.
D. The Company and the Investors desire to amend, modify and waive certain provisions under the Purchase Agreement as set forth in this Amendment.
AGREEMENT
In consideration of the foregoing recitals, the mutual covenants and agreements contained herein, and other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the Company and the Investors agree as follows:
1. Amendments to Section 1.1 of the Purchase Agreement.
a. The following definitions are hereby added to Section 1.1 of the Purchase Agreement in their relevant alphabetical location:
““HLHS Program” means the Company’s laromestrocel program for Hypoplastic Left Heart Syndrome, including all regulatory filings, clinical data, intellectual property, know- how and other assets relating thereto.”
““Program Transfer” means any sale, transfer, assignment, license, conveyance or other disposition (whether by merger, asset sale, exclusive license or otherwise) of all or substantially all of the HLHS Program, or any material portion thereof sufficient to enable the transferee to seek or obtain regulatory approval from the FDA for the HLHS Program, to any Person other than a wholly-owned subsidiary of the Company.”
““Program Transferee” means any Person that acquires or receives all or any portion of the HLHS Program pursuant to a Program Transfer.”
b. Section 1.1 of the Purchase Agreement is hereby amended by amending and restating the following definition in its entirety to read as follows:
““PRV Interest” means 50% of the proceeds received by the Company or any Program Transferee, as applicable, from a sale of the PRV, as contemplated in Section 5.13, after deducting any necessary and documented third-party fees or charges associated with such sale.”
2. Amendment and Restatement of Section 5.13 of the Purchase Agreement. Section 5.13 of the Purchase Agreement is hereby amended and restated in its entirety as follows:
“Priority Review Voucher.
(a) The Company hereby covenants and agrees that, in the event the Company receives from the FDA a Rare Pediatric Disease Priority Review Voucher (“PRV”) in connection with the HLHS Program, the Company shall use commercially reasonable efforts to sell the PRV to a third party in a bona fide arm’s length transaction. Upon the sale of the PRV, the Company shall direct that the proceeds relating to the PRV Interest shall be paid directly to the Investors at the closing of the PRV sale. Such distribution of the PRV Interest proceeds shall be made to the Investors on a pro rata basis in accordance with each Investor’s relative ownership of the Preferred Stock as of the date of the PRV sale. The Investors acknowledge and agree that upon the conversion of the Preferred Stock prior to the PRV sale, they are foregoing a portion of their respective interest in the PRV Interest and are ratably increasing the interest of other Investors who do not convert Preferred Stock proportionately. If all Preferred Stock has been converted prior to the sale of the PRV, then the last-to-convert Investor will be entitled to all of proceeds arising from the PRV Interest.
(b) In the event of a Program Transfer, the Company shall include provisions in the documentation effecting the Program Transfer wherein the Program Transferee expressly assumes and agrees to the obligations set forth in Section 5.13(a), including: (i) to use commercially reasonable efforts to sell any PRV received by the Program Transferee in connection with the HLHS Program to a third party in a bona fide arm’s length transaction; (ii) to pay the PRV Interest directly to the Investors upon the sale of such PRV; and (iii) to require any subsequent transferee of the HLHS Program to undertake and assume the same obligations on substantially the same terms.
(c) In connection with any Program Transfer, the Company shall provide Investors holding Preferred Stock at such time with written notice of such intended Program Transfer prior to the closing of the same.
3. Effect. Except as provided above, the provisions of the Purchase Agreement are hereby ratified and confirmed in all respects. This Amendment shall be construed with and interpreted as part of the Purchase Agreement, and all references to the Purchase Agreement in the Purchase Agreement shall, unless the context otherwise requires, mean the Purchase Agreement as amended by this Amendment.
4. Miscellaneous. Sections 10.2 (Notices), 10.3 (Consent to Electronic Notice), 10.4 (Severability), 10.5 (Governing Law; Submission to Jurisdiction; Venue; Waiver of Trial by Jury), 10.6 (Waiver), 10.8 (Assignment), 10.11 (Third Parties), 10.13 (Headings), 10.14 (Counterparts), 10.15 (Entire Agreement; Amendments), 10.17 (Contract Interpretation) and 10.18 (Arm’s Length Negotiations) of the Purchase Agreement are hereby incorporated by reference into this Amendment, mutatis mutandis.
[Signature Page Follows]
IN WITNESS WHEREOF, the parties hereto have executed this Agreement as of the day and year first above written.
COMPANY: |
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LONGEVERON INC. |
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By: |
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/s/ Stephen Willard |
Name: |
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Stephen Willard |
Title: |
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CEO |
[Signature Page to Amendment No. 1 to Purchase Agreement]
IN WITNESS WHEREOF, the parties hereto have executed this Agreement as of the day and year first above written.
INVESTOR: |
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COASTLANDS CAPITAL PARTNERS LP |
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By: |
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/s/ Mark Shamia |
Name: |
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Mark Shamia |
Title: |
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Chief Financial Officer |
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Address: |
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601 California Street, Suite 1210 |
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San Francisco, CA 94108 |
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Email: [email protected] |
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[Signature Page to Amendment No. 1 to Purchase Agreement]
Exhibit 31.1
Rule 13a-14(a)/15(d)-14(a) Certifications
I, Stephen H. Willard, certify that:
Date: August 12, 2026 |
/s/ Stephen H. Willard |
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Stephen H. Willard |
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Chief Executive Officer |
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Exhibit 31.2
Rule 13a-14(a)/15(d)-14(a) Certifications
I, Marie Washburn, certify that:
Date: August 12, 2026 |
/s/ Marie Washburn |
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Marie Washburn |
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Senior Vice President and Chief Financial Officer |
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Exhibit 32.1
SECTION 1350 CERTIFICATION
Pursuant to the requirement set forth in Rule 13a-14(b) or Rule 15d-14(b) of the Securities Exchange Act of 1934, as amended, and Section 1350 of Chapter 63 of Title 18 of the United States Code (18 U.S.C. § 1350), as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, Stephen H. Willard, Chief Executive Officer (principal executive officer) of Longeveron Inc. (the “Company”), and Marie Washburn, the Chief Financial Officer (principal financial officer) of the Company, each hereby certifies that, to his or her knowledge on the date hereof:
This certification shall not be deemed to be filed with the Securities and Exchange Commission and shall not be incorporated by reference into any filing of the Company under the Securities Act of 1933, as amended, or the Securities Exchange Act of 1934, as amended (whether made before or after the date of the Quarterly Report), irrespective of any general incorporation language contained in such filing. A signed original of this written statement required by Section 906 has been provided to the Company and will be retained and furnished to the Securities and Exchange Commission or its staff upon request.
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/s/ Stephen H. Willard |
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Stephen H. Willard |
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Chief Executive Officer |
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(Principal Executive Officer) |
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August 12, 2026 |
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/s/ Marie Washburn |
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Marie Washburn |
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Senior Vice President and Chief Financial Officer |
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(Principal Financial Officer) |
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August 12, 2026 |