Clearside Biomedical, Inc 10-Q for FY2025 Q3
Clearside Biomedical, Inc. (CLSDQ)
About this 10-Q
Clearside Biomedical, Inc filed this 10-Q on November 14, 2025, covering the quarter ended September 30, 2025 (FY2025 Q3).
Headline figures
Quarter ended September 30, 2025, as reported in this filing, compared with the same period a year earlier where the filing states it.
- Revenue
- $201K
- down 80.6% from $1.04M a year earlier
- Net loss
- $5.97M
- compared with a net loss of $7.69M a year earlier
- Diluted EPS
- -$1.14
- compared with -$1.54 a year earlier
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, DC 20549
FORM
(Mark One)
For the quarterly period ended
OR
Commission File Number:
(Exact Name of Registrant as Specified in its Charter)
(State or other jurisdiction of incorporation or organization) |
(I.R.S. Employer |
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Registrant’s telephone number, including area code
N/A
(Former name, former address and former fiscal year, if changed since last report)
Securities registered pursuant to Section 12(b) of the Act:
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Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.
Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§ 232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files).
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.
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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 November 12, 2025, the registrant had
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PART I - FINANCIAL INFORMATION |
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Item 1. |
Financial Statements (unaudited) |
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Consolidated Balance Sheets as of September 30, 2025 and December 31, 2024 |
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Consolidated Statements of Stockholders’ Deficit for the three and nine months ended September 30, 2025 and 2024 |
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Consolidated Statements of Cash Flows for the nine months ended September 30, 2025 and 2024 |
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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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PART II - OTHER INFORMATION |
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Item 1. |
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Item 1A |
Risk Factors |
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Item 2. |
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Item 5. |
Other Information |
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Item 6. |
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PART I – FINANCIAL INFORMATION
Item 1. Financial Statements
CLEARSIDE BIOMEDICAL, INC.
Consolidated Balance Sheets
(in thousands, except share and per share data)
(unaudited)
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September 30, |
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December 31, |
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Assets |
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Current assets: |
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Cash and cash equivalents |
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Accounts receivable |
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Prepaid expenses |
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Other current assets |
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Total current assets |
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Property and equipment, net |
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Operating lease right-of-use asset |
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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’ deficit |
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Current liabilities: |
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Accounts payable (includes $ |
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$ |
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Accrued liabilities (includes $ |
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Current portion of operating lease liabilities |
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Total current liabilities |
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Liability related to the sales of future royalties, net |
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Warrant liabilities |
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Operating lease liabilities |
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Other non-current liabilities |
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Total liabilities |
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Stockholders’ deficit: |
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Preferred stock, $ |
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Common stock, $ |
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Additional paid-in capital |
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Accumulated deficit |
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Total stockholders’ deficit |
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Total liabilities and stockholders’ deficit |
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$ |
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$ |
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(1)
See accompanying notes to the consolidated financial statements.
3
CLEARSIDE BIOMEDICAL, INC.
Consolidated Statements of Operations
(in thousands, except share and per share data)
(unaudited)
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Three Months Ended |
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Nine Months Ended |
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2025 |
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2024 |
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2025 |
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2024 |
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$ |
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Operating expenses: |
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Cost of goods sold |
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Research and development (includes $ |
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General and administrative |
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Total operating expenses |
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Loss from operations |
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Interest income |
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Other income, net |
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Non-cash interest expense on liability |
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Loss before income taxes |
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Income tax expense |
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Net loss |
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Net loss per share of common stock — basic and diluted (1) |
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$ |
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$ |
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$ |
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Weighted average shares outstanding — basic and diluted (1) |
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Net loss |
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Unrealized gain on available-for-sale investments |
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Comprehensive loss |
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(1) Results, including shares issued and outstanding have been adjusted to reflect the one-for-fifteen reverse stock split effected in September 2025. See Note 1, The Company, for details.
See accompanying notes to the consolidated financial statements.
4
CLEARSIDE BIOMEDICAL, INC.
Consolidated Statements of Stockholders’ Deficit
(in thousands, except share data)
(unaudited)
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Nine Months Ended September 30, 2025 |
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Total |
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Common Stock |
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Additional |
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Accumulated |
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Stockholders' |
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Shares |
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Amount |
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Paid-In-Capital |
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Deficit |
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Deficit |
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Balance at December 31, 2024 |
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$ |
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$ |
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Issuance of common stock under at-the-market |
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— |
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— |
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Vesting and settlement of restricted stock units |
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— |
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— |
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— |
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— |
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Issuance of common stock under employee stock |
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— |
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— |
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Share-based compensation expense |
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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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Balance at March 31, 2025 |
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( |
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Issuance of common stock under at-the-market |
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— |
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Share-based compensation expense |
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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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Balance at June 30, 2025 |
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( |
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Issuance of common stock under employee stock |
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— |
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— |
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Share-based compensation expense |
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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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Balance at September 30, 2025 |
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$ |
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$ |
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$ |
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$ |
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Nine Months Ended September 30, 2024 |
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Accumulated |
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Other |
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Total |
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Common Stock |
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Additional |
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Accumulated |
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Comprehensive |
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Stockholders' |
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Shares (1) |
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Amount |
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Paid-In-Capital |
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Deficit |
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Loss |
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Deficit |
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Balance at December 31, 2023 |
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$ |
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$ |
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$ |
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$ |
— |
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$ |
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Issuance of common stock under registered direct |
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— |
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— |
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Issuance of common stock under at-the-market |
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— |
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— |
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— |
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Exercise of stock options |
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— |
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— |
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— |
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Vesting and settlement of restricted stock units |
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— |
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— |
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— |
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— |
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— |
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Issuance of common stock under employee |
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— |
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— |
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— |
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Share-based compensation expense |
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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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Balance at March 31, 2024 |
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( |
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— |
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Share-based compensation expense |
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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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Other comprehensive loss |
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— |
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— |
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— |
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— |
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( |
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( |
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Balance at June 30, 2024 |
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( |
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( |
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Issuance of common stock under the employee |
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— |
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— |
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Share-based compensation expense |
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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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Other comprehensive gain |
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— |
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— |
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— |
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— |
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Balance at September 30, 2024 |
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$ |
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$ |
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$ |
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$ |
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$ |
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(1)
See accompanying notes to the consolidated financial statements.
5
CLEARSIDE BIOMEDICAL, INC.
Consolidated Statements of Cash Flows
(in thousands)
(unaudited)
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Nine Months Ended |
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2025 |
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2024 |
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Operating activities |
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Net loss |
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Adjustments to reconcile net loss to net cash used in operating activities: |
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Non-cash interest expense on liability related to the sales of |
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Depreciation |
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Share-based compensation expense |
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Change in fair value of warrant liabilities |
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Issuance costs allocated to warrant liabilities |
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Amortization and accretion of available-for-sales investments, net |
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Changes in operating assets and liabilities: |
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Prepaid expenses and other current assets |
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Other assets and liabilities |
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Accounts payable and accrued liabilities (includes $ |
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Deferred revenue |
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Net cash used in operating activities |
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Investing activities |
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Acquisition of property and equipment |
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Purchase of short-term investments |
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Maturity of short-term investments |
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Net cash used in investing activities |
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Financing activities |
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Proceeds from issuance of common stock and warrants under |
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Proceeds from at-the-market sales agreement, net of issuance costs |
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Proceeds from royalty purchase and sale agreement, net of issuance costs |
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Payments on royalty purchase and sale agreement |
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Proceeds from exercise of stock options |
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Proceeds from shares issued under employee stock purchase plan |
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Net cash provided by financing activities |
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Net decrease in cash and cash equivalents |
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Cash and cash equivalents, beginning of period |
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Cash and cash equivalent, end of period |
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$ |
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$ |
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Supplemental disclosure |
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Purchase of property and equipment included in accrued liabilities |
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$ |
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$ |
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See accompanying notes to the consolidated financial statements.
6
CLEARSIDE BIOMEDICAL, INC.
Notes to the Consolidated Financial Statements
(unaudited)
1. The Company
Clearside Biomedical, Inc. (the “Company”) is a biopharmaceutical company focused on revolutionizing the delivery of therapies to the back of the eye through the suprachoroidal space (SCS®). Incorporated in the State of Delaware on
The Company’s activities since inception have primarily consisted of developing product and technology rights, raising capital and performing research and development activities. The Company is subject to a number of risks and uncertainties similar to those of other life science companies at a similar stage of development, including, among others, the need to obtain adequate additional financing, successful development efforts including regulatory approval of products, compliance with government regulations, successful commercialization of potential products, protection of proprietary technology and dependence on key individuals.
Reverse Stock Split
On August 29, 2025, the Company held a special meeting of stockholders at which its stockholders approved a proposal to effect an amendment to the Company’s Amended and Restated Certificate of Incorporation to implement a reverse stock split and a corresponding reduction in the total number of authorized shares of the Company’s common stock. On September 4, 2025, the Company’s board of directors approved the filing of a certificate of amendment to the Company’s Restated Certificate of Incorporation with the Secretary of State of the State of Delaware to affect the one-for-fifteen (1:15) reverse stock split of its outstanding common stock and a corresponding reduction in the total number of authorized shares of the Company’s common stock (the “Reverse Stock Split”).
On September 12, 2025, the Company effected the Reverse Stock Split. Pursuant to their terms, a proportionate adjustment was made to the per share exercise price and number of shares issuable under all of the Company’s outstanding options and warrants, and the number of shares authorized for issuance pursuant to the Company’s equity incentive plans have been reduced proportionately.
No fractional shares were issued as a result of the Reverse Stock Split. Stockholders of record who would have otherwise been entitled to receive a fractional share received a cash payment in lieu thereof. The Reverse Stock Split affected all stockholders proportionately and did not affect any stockholder’s percentage ownership of the Company’s common stock (except to the extent that the Reverse Stock Split resulted in any stockholder owning only a fractional share).
Liquidity
The Company had cash and cash equivalents of $
Historically, the Company has funded its operations primarily through the sale of common stock and convertible preferred stock, the issuance of warrants, the issuance of long-term debt, and license agreements.
On September 4, 2025, the Company entered into an Omnibus Amendment Agreement (the “Amendment”) with Royalty Sub (as defined below) and with entities managed by HCR (as defined below). Pursuant to the Amendment, Royalty Sub received an additional payment of $
On February 6, 2024, the Company entered into a securities purchase agreement with institutional investors and an existing stockholder, pursuant to which the Company issued and sold, in a registered direct offering (the “Registered Direct Offering”): (i) an
7
aggregate of
On January 31, 2024 (the “Amendment Effective Date”), the Company entered into a fourth amendment to the license agreement (as amended, the “Emory License Agreement”) with Emory University and Georgia Tech Research Corporation (collectively, the “Licensor”) pursuant to which the parties agreed to reduce the Sublicense Percentage (as defined in the Emory License Agreement) from a low double digit percentage to a high single digit percentage that the Company will pay the Licensor applicable to any fees or payments paid to the Company by any Sublicensee (as defined in the Emory License Agreement) of the Licensed Patents and/or Licensed Technology (each as defined in the Emory License Agreement), excluding (i) amounts paid to the Company by a Sublicensee to reimburse the Company for certain research and development costs pursuant to a written agreement between the Company and such Sublicensee, (ii) the value of intellectual property transferred or granted to the Company if necessary or helpful to the development or commercialization of Licensed Products (as defined in the Emory License Agreement) and (iii) amounts paid for shares of the Company’s stock. The payment to Licensor of any such Sublicense Percentage is due within 30 days of receipt by the Company of a qualifying payment from a Sublicensee, provided however, with respect to any qualifying payments received by the Company from a Sublicensee after July 1, 2023 but prior to January 1, 2025, the payment to Licensor of any such Sublicensee Percentage was due to Licensor by March 31, 2025. The parties also agreed to a revised annual license maintenance fee due each year (the “Maintenance Fee”) starting in 2023 through 2028, as follows: $
In May 2023, the Company entered into a Controlled Equity OfferingSM Sales Agreement (the "Sales Agreement") with Cantor Fitzgerald & Co. ("Cantor") under which the Company may offer and sell, from time to time at its sole discretion, shares of its common stock, having an aggregate offering price of up to $
The Company has suffered recurring losses and negative cash flows from operations since inception and anticipates incurring additional losses until such time, if ever, that it can generate significant revenue. The Company has no current source of revenue to sustain present activities. The Company does not expect to generate other meaningful revenue until and unless the Company's licensees successfully commercialize XIPERE and the Company has fulfilled its obligations under the Purchase and Sale Agreement (as defined below), its other licensees receive regulatory approval and successfully commercialize its product candidates, or the Company commercializes its product candidates either on its own or with a third party. In the absence of product or other revenues, the amount, timing, nature or source of which cannot be predicted, the Company’s losses will continue as it conducts its research and development activities.
The Company will continue to need to obtain additional financing to fund future operations, including completing the development, partnering and potential commercialization of its primary product candidates. The Company will need to obtain financing to complete the development and conduct clinical trials for the regulatory approval of its product candidates if requested by regulatory bodies. If such product candidates were to receive regulatory approval, the Company would need to obtain financing to prepare for the potential commercialization of its product candidates, if the Company decides to commercialize the products on its own.
These conditions raise substantial doubt about the Company’s ability to continue as a going concern within one year after the date the consolidated financial statements are issued. Based on its current plans and forecasted expenses, the Company does not expect its cash and cash equivalents will enable the Company to fund its planned operating expenses for the next 12 months from the date of this filing.
Accordingly, the Company’s consolidated financial statements have been prepared on a going concern basis, which contemplates the realization of assets and satisfaction of liabilities in the normal course of business. The consolidated financial statements do not include any adjustments to reflect the possible future effects on the recoverability and classification of recorded asset amounts or the amounts and classification of liabilities that might result should the Company be unable to continue as a going concern.
Until the Company can generate sufficient revenue, the Company will need to finance future cash needs through public or private equity offerings, license agreements, debt financings or restructurings, collaborations, strategic alliances and marketing or distribution arrangements.
8
2. Significant Accounting Policies
Basis of Presentation and Principles of Consolidation
The Company's consolidated financial statements include the results of the financial operations of Clearside Biomedical, Inc. and Royalty Sub, which was formed for the purposes of the transactions contemplated by the Purchase and Sale Agreement described in Note 5. All intercompany balances and transactions have been eliminated.
The Company’s consolidated financial statements have been prepared in conformity with U.S. generally accepted accounting principles (“U.S. GAAP”). In the opinion of management, the Company has made all necessary adjustments, which include normal recurring adjustments necessary for a fair statement of the Company’s consolidated financial position and results of operations for the interim periods presented. The results for the three and nine months ended September 30, 2025 are not indicative of results to be expected for the full year ending December 31, 2025, any other interim periods or any future year or period. These unaudited consolidated financial statements should be read in conjunction with the audited consolidated financial statements and related footnotes, which are included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2024, filed with the Securities and Exchange Commission on March 27, 2025.
During the nine months ended September 30, 2025, the Company recorded an immaterial out of period adjustment of $
Use of Estimates
The preparation of consolidated 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 consolidated financial statements and reported amounts of income and expenses during the reporting periods. Significant items subject to such estimates and assumptions include the estimate of the total amount of future royalty revenue and milestone payments to be generated over the life of the Purchase and Sale Agreement described in Note 5, certain assumptions used in the valuation of warrant liabilities, revenue recognition, the accounting for useful lives to calculate depreciation and amortization, clinical trial expense accruals, share-based compensation expense and income tax valuation allowance. Actual results could differ from these estimates.
Revenue Recognition
The Company recognizes revenue from its contracts with customers under Financial Accounting Standards Board ("FASB") Accounting Standards Codification (“ASC”) 606, Revenue from Contracts with Customers. The Company’s primary revenue arrangements are license agreements, which typically include upfront payments, regulatory and commercial milestone payments and royalties based on future product sales. The arrangements may also include payments for the Company’s SCS Microinjector devices as well as payments for assistance and oversight of the customer’s use of the Company’s technology. In determining the amount of revenue to be recognized under these agreements, the Company performs the following steps: (i) identifies the promised goods and services to be transferred in the contract, (ii) identifies the performance obligations, (iii) determines the transaction price, (iv) allocates the transaction price to the performance obligations and (v) recognizes revenue as the performance obligations are satisfied.
The Company receives payments from its customers based on billing schedules established in each contract. Upfront and other payments may require deferral of revenue recognition to a future period until the Company performs its obligations under the arrangement. Amounts are recorded as accounts receivable when the Company’s right to consideration is unconditional. The Company does not assess whether a contract has a significant financing component if the expectation at contract inception is such that the period between payment by the customer and the transfer of the promised goods or services to the customer will be one year or less.
Research and Development Costs
Research and development costs are charged to expense as incurred and include:
9
Costs for certain development activities, such as clinical trial activities, are recognized based on an evaluation of the estimated total costs for the clinical trial, progress to completion of specific tasks using data such as participant enrollment, pass-through expenses, clinical site activations, data from the clinical sites or information provided to the Company by its vendors on their actual costs incurred. Payments for these activities are based on the terms of the individual contracts and any subsequent amendments, which may differ from the patterns of costs incurred, and are reflected in the consolidated financial statements as prepaid expenses or accrued liabilities.
Share-Based Compensation
Compensation cost related to share-based awards granted to employees, directors and consultants is measured based on the estimated fair value of the award at the grant date. The Company estimates the fair value of stock options using a Black-Scholes option pricing model. The fair value of restricted stock units granted is measured based on the market value of the Company’s common stock on the date of grant. Share-based compensation costs are expensed on a straight-line basis over the relevant vesting period. The Reduction in Force implemented in July 2025 did not change the vesting terms and conditions of the share-based awards.
Compensation cost related to shares purchased through the Company’s employee stock purchase plan, which is considered compensatory, is based on the estimated fair value of the shares on the offering date, including consideration of the discount and the look-back period. The Company estimates the fair value of the shares using a Black-Scholes option pricing model. Compensation expense is recognized over the six-month withholding period prior to the purchase date.
All share-based compensation costs are recorded in general and administrative or research and development costs in the consolidated statements of operations based upon the recipient's underlying role within the Company.
Cash Equivalents
Cash equivalents consist of short-term, highly liquid investments with an original term of three months or less at the date of purchase.
Concentration of Credit Risk Arising From Cash Deposits in Excess of Insured Limits
The Company maintains its cash in bank deposits that at times may exceed federally insured limits. The Company has not experienced any loss in such accounts. The Company believes it is not exposed to any significant risks with respect to its cash balances.
Liability Related to the Sales of Future Royalties and Non-Cash Interest Expense
In connection with the Purchase and Sale Agreement, the Company recognizes a liability related to the sales of future royalties under ASC 470-10, Debt and ASC 835-30, Interest - Imputation of Interest. The initial funds received by the Company pursuant to the terms of the Purchase and Sale Agreement were recorded as a liability and are accreted under the effective interest method up to the estimated amount of future royalties and milestone payments to be made under the Purchase and Sale Agreement. The issuance costs were recorded as a direct deduction to the carrying amount of the liability and are being amortized under the effective interest method over the estimated period the liability will be repaid. The Company estimates the total amount of future royalty revenue and milestone payments to be generated over the life of the Purchase and Sale Agreement, and a significant increase or decrease in these estimates could materially impact the liability balance and the related interest expense. If the timing of the receipt of royalty payments or milestones is materially different from the original estimates, the Company will prospectively adjust the effective interest and the related amortization of the liability and related issuance costs.
Warrant Liabilities
The Company accounts for warrants as either equity-classified or liability-classified instruments based on an assessment of the warrant’s specific terms and applicable authoritative guidance in ASC 480, Distinguishing Liabilities from Equity ("ASC 480") and ASC 815, Derivatives and Hedging ("ASC 815"). The assessment considers whether the warrants (i) are freestanding financial instruments pursuant to ASC 480, (ii) meet the definition of a liability pursuant to ASC 480, and (iii) meet all of the requirements for equity classification under ASC 815, including whether the warrants are indexed to the Company's own stock and whether the warrant holders could potentially require “net cash settlement” in a circumstance outside of the Company’s control, among other conditions for equity classification. This assessment, which requires the use of professional judgment, is conducted at the time of warrant issuance and as of each subsequent quarterly period end date while the warrants are outstanding.
For warrants that meet all criteria for equity classification, the warrants are required to be recorded as a component of additional paid-in capital, on the consolidated statement of stockholders’ deficit at the time of issuance. For warrants that do not meet all the criteria for equity classification, the warrants are required to be recorded at their initial fair value on the date of issuance and on each consolidated balance sheet date thereafter.
10
The Company’s warrant liabilities are measured at fair value using a simulation model which takes into account, as of the valuation date, factors including the current exercise price, the expected life of the warrant, the current price of the Company's common stock, the expected volatility, the risk-free interest rate for the term of the warrant and the likelihood of achieving certain future milestone events and the related impact to the price of the Company's common stock. The warrant liabilities are revalued at each reporting period and changes in fair value are recognized in other income, net in the consolidated statements of operations. The selection of the appropriate valuation model and the inputs and assumptions that are required to determine the valuation requires significant judgment and requires management to make estimates and assumptions that affect the reported amount of the related liability and reported amounts of the change in fair value. Actual results could differ from those estimates, and changes in these estimates are recorded when known. See Note 7 for further details.
Recently Issued Accounting Pronouncements
In December 2023, the FASB issued Accounting Standards Update ("ASU") 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures. This ASU is intended to enhance the transparency and decision usefulness of income tax disclosures primarily related to the rate reconciliation and income taxes paid information. The main provisions to the rate reconciliation disclosure require public entities to disclose, on an annual basis, specific categories in the rate reconciliation and provide additional information for reconciling items that meet a quantitative threshold. The main provisions to the income taxes paid disclosure require that all entities disclose on an annual basis: the amount of income taxes paid disaggregated by federal, state and foreign taxes and the amount of income taxes paid disaggregated by individual jurisdictions in which income taxes paid meets a quantitative threshold. This ASU also requires all entities to disclose income (loss) from continuing operations before income tax expense (benefit) disaggregated between domestic and foreign and income tax expense (benefit) from continuing operations disaggregated by federal, state and foreign. The Company adopted ASU 2023-09 on January 1, 2025. The adoption did not have a material impact on its consolidated financial statements.
In November 2024, the FASB issued ASU 2024-03, Income Statement-Reporting Comprehensive Income-Expense Disaggregation Disclosures. This ASU requires disclosure of disaggregated income statement expense information about specific categories including purchases of inventory, employee compensation expense, depreciation and amortization in the notes to the financial statements. This ASU is effective January 1, 2027 for annual reporting periods and January 1, 2028 for interim reporting periods. The Company is currently evaluating the impact of this ASU on its consolidated financial statements.
3. Property and Equipment, Net
Property and equipment, net consisted of the following (dollar amounts in thousands):
|
|
Estimated |
|
September 30, |
|
|
December 31, |
|
||
Furniture and fixtures |
|
|
$ |
|
|
$ |
|
|||
Machinery and equipment |
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|||
Computer equipment |
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Leasehold improvements |
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|
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||
Work in process |
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|
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|
|
|
||
Total property and equipment |
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|
|
|
|
|
||
Less: Accumulated depreciation |
|
|
|
|
( |
) |
|
|
( |
) |
Property and equipment, net |
|
|
|
$ |
|
|
$ |
|
||
4. Accrued Liabilities
Accrued liabilities consisted of the following (in thousands):
|
|
September 30, |
|
|
December 31, |
|
||
|
|
2025 |
|
|
2024 |
|
||
Accrued research and development |
|
$ |
|
|
$ |
|
||
Accrued income taxes |
|
|
|
|
|
|
||
Accrued employee costs |
|
|
|
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|
||
Accrued professional fees |
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|
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|
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||
Accrued expense |
|
|
|
|
|
|
||
|
|
$ |
|
|
$ |
|
||
11
5. Royalty Purchase and Sale Agreement
On August 8, 2022 (the “Closing Date”), the Company, through its wholly owned subsidiary Clearside Royalty LLC, a Delaware limited liability company ("Royalty Sub"), entered into the Purchase and Sale Agreement (the "Purchase and Sale Agreement") with entities managed by HealthCare Royalty Management, LLC ("HCR"), pursuant to which Royalty Sub sold to HCR certain of its rights to receive royalty and milestone payments payable to Royalty Sub under the Arctic Vision License Agreement (as defined in Note 10), the Bausch License Agreement (as defined in Note 10), that certain License Agreement, effective as of July 3, 2019, by and between the Company and Aura Biosciences, Inc. (the “Aura License Agreement”), that certain Option and License Agreement, dated as of August 29, 2019, by and between REGENXBIO Inc. and the Company (the “REGENXBIO License Agreement”), and any and all out-license agreements following the Closing Date for, or related to XIPERE or the SCS Microinjector technology (to be used in connection with compounds or products of any third parties) delivered, in whole or in part, by means of the SCS Microinjector technology) (collectively, "Post-Closing License Agreement"), excluding, for the avoidance of doubt, any in-licensed or internally developed therapies following the Closing Date (collectively, the “Royalties”), in exchange for up to $
Under the terms of the Purchase and Sale Agreement, Royalty Sub received an initial payment of $
Under the terms of the original Purchase and Sales Agreement, the
On December 22, 2023, the Company, through its wholly owned subsidiary Royalty Sub, entered into the Letter Agreement with the Agent amending the Purchase and Sale Agreement. Pursuant to the terms of the Letter Agreement, Royalty Sub and Agent mutually agreed that Royalty Sub waived any and all rights to the First Milestone Payment in connection with the closing of the transactions contemplated by the Purchase and Sale Agreement and agreed to the release of the First Milestone Payment to Agent.
Issuance costs pursuant to the Purchase and Sale Agreement consisting primarily of advisory and legal fees, totaled $
Pursuant to the Purchase and Sale Agreement, in August 2022, Royalty Sub sold HCR certain of its rights to receive royalty and milestone payments payable Royalty Sub under existing license agreements related to XIPERE (triamcinolone acetonide injectable suspension) or the Company’s SCS Microinjector technology (collectively, the “Royalties”), and Royalty Sub received $
On September 4, 2025, pursuant to the Amendment, Royalty Sub received an additional payment of $
12
and Sale Agreement to expire, and the payment of Royalties from the Royalty Sub to the Purchaser to cease, from $
The following table summarizes the activity of the Purchase and Sale Agreement (in thousands):
Balance at December 31, 2023 |
|
$ |
|
|
Non-cash interest expense |
|
|
|
|
Balance at December 31, 2024 |
|
|
|
|
Proceeds, net of issuance costs |
|
|
|
|
Payments |
|
|
( |
) |
Non-cash interest expense |
|
|
|
|
Balance at September 30, 2025 |
|
$ |
|
|
|
|
|
|
|
Effective interest rate |
|
|
% |
|
6. Common Stock
At the Company's 2025 annual meeting of stockholders held on May 30, 2025, the Company's stockholders approved an amendment to the Company's Amended and Restated Certificate of Incorporation to increase the Company's authorized number of shares of common stock from 13,333,333 to 26,666,666 . On September 12, 2025, the Company effected a 1-for-15 reverse stock split of its issued and outstanding shares of common stock. As of September 30, 2025, the Company was authorized to issue 26,666,666 shares of common stock, $0.001 par value.
On August 29, 2025, the Company held a special meeting of stockholders at which its stockholders approved a proposal to effect an amendment to the Company’s Amended and Restated Certificate of Incorporation to implement the Reverse Stock Split. On September 4, 2025, the Company’s Board of Directors approved the filing of a certificate of amendment to the Company’s Restated Certificate of Incorporation with the Secretary of State of the State of Delaware to affect the Reverse Stock Split.
On September 12, 2025, the Company effected the Reverse Stock Split. Pursuant to their terms, a proportionate adjustment was made to the per share exercise price and number of shares issuable under all of the Company’s outstanding options and warrants, and the number of shares authorized for issuance pursuant to the Company’s equity incentive plans have been reduced proportionately.
As of September 30, 2025 and December 31, 2024, there were 5,233,981 and 5,105,216 shares of common stock outstanding, respectively.
7. Common Stock Warrants
In September 2016, in connection with a loan agreement, the Company issued warrants to purchase up to
On February 6, 2024, the Company entered into a securities purchase agreement with institutional investors and an existing stockholder, pursuant to which the Company issued and sold, in a registered direct offering (i) an aggregate of
The combined purchase price of each Share and accompanying Warrant was $
The following table summarizes the change in fair value of the warrant liabilities (in thousands):
Fair value of warrants at issuance February 9, 2024 |
|
$ |
|
|
Change in fair value during the period |
|
|
( |
) |
Fair value of warrants at December 31, 2024 |
|
|
|
|
Change in fair value during the period |
|
|
( |
) |
Fair value of warrants at September 30, 2025 |
|
$ |
|
13
The following table summarizes certain key inputs for the valuation of the Warrants at September 30 2025:
Common stock price |
|
$ |
|
|
|
Exercise price per share |
|
$ |
|
|
|
Expected volatility |
|
|
|
% |
|
Risk-free interest rate |
|
|
|
% |
|
Contractual term (in years) |
|
|
|
|
|
Expected dividend yield |
|
|
|
% |
As described in Note 2, the measurement of the warrant liabilities is impacted by the likelihood of achieving certain future milestone events and the related impact to the Company’s stock price. In determining the likelihood of achieving certain future milestone events, the Company considers its current financial position and ability to fund future clinical activities as described in Note 1. The Company utilizes publicly available information from external parties to assess the related impact to the Company’s stock price from the success of these activities.
8. Share-Based Compensation
Share-based compensation is accounted for in accordance with the provisions of ASC 718, Compensation-Stock Compensation.
Stock Options
The Company has granted stock option awards to employees, directors and consultants from its 2011 Stock Incentive Plan (the “2011 Plan”) and its 2016 Equity Incentive Plan (the “2016 Plan”). The estimated fair value of options granted is determined as of the date of grant using the Black-Scholes option pricing model. The resulting fair value is recognized ratably over the requisite service period, which is generally the vesting period of the awards.
Share-based compensation expense for options granted under the 2016 Plan is reflected in the consolidated statements of operations as follows (in thousands):
|
|
Three Months Ended |
|
|
Nine Months Ended |
|
||||||||||
|
|
2025 |
|
|
2024 |
|
|
2025 |
|
|
2024 |
|
||||
Research and development |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
General and administrative |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Total |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
The following table summarizes the activity related to stock options granted under the 2011 Plan and the 2016 Plan during the nine months ended September 30, 2025:
|
|
|
|
|
Weighted |
|
||
|
|
Number of |
|
|
Average |
|
||
|
|
Shares |
|
|
Exercise Price |
|
||
Options outstanding at December 31, 2024 |
|
|
|
|
$ |
|
||
Granted |
|
|
|
|
|
|
||
Forfeited |
|
|
( |
) |
|
|
|
|
Options outstanding at September 30, 2025 |
|
|
|
|
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|
||
|
|
|
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|
|
|
||
Options exercisable at December 31, 2024 |
|
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||
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|
|
|
|
|
||
Options exercisable at September 30, 2025 |
|
|
|
|
|
|
||
As of September 30, 2025, the Company had $
Restricted Stock Units
The Company has granted restricted stock units (“RSUs”) to employees and consultants under the 2016 Plan. The shares underlying the RSU awards have vesting terms of four years from the date of grant subject to the recipient's continuous service and subject to accelerated vesting in specified circumstances. The fair value of the RSUs granted is measured based on the market value of
14
the Company’s common stock on the date of grant and is recognized ratably over the requisite service period, which is generally the vesting period of the awards.
The total share-based compensation expense related to RSUs is reflected in the consolidated statements of operations as follows (in thousands):
|
|
Three Months Ended |
|
|
Nine Months Ended |
|
||||||||||
|
|
2025 |
|
|
2024 |
|
|
2025 |
|
|
2024 |
|
||||
Research and development |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
General and administrative |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Total |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
The following table summarizes the activity related to RSUs during the nine months ended September 30, 2025:
|
|
|
|
|
Weighted Average |
|
||
|
|
Number of |
|
|
Grant Date |
|
||
|
|
Shares |
|
|
Fair Value |
|
||
Non-vested RSUs outstanding at December 31, 2024 |
|
|
|
|
$ |
|
||
Vested |
|
|
( |
) |
|
|
|
|
Non-vested RSUs outstanding at September 30, 2025 |
|
|
|
|
|
|
||
As of September 30, 2025, the Company had $
9. Commitments and Contingencies
Lease Commitment Summary
In November 2022, the Company signed an amended office lease agreement to lease approximately
The Company recognizes a right-of-use asset for the right to use the underlying asset for the lease term, and a lease liability, which represents the present value of the Company’s obligation to make payments over the lease term.
Equipment leases with an initial term of 12 months or less are not recorded with operating lease liabilities. The Company recognizes expense for these leases on a straight-line basis over the lease term. The equipment leases were deemed to be immaterial.
Georgia Tech License Agreement
As described in Note 1, the Company entered into a fourth amendment to the Georgia Tech License Agreement pursuant to which the parties agreed to revised Maintenance Fee payments in exchange for a reduction to the contractual Sublicense Percentage owed by the Company on certain fees and other payments it may receive from future sublicensing activities. The Company paid the $
Year Ending December 31, |
|
Amount |
|
|
2025 |
|
$ |
|
|
2026 |
|
|
|
|
2027 |
|
|
|
|
2028 |
|
|
|
|
Total |
|
$ |
|
|
Contract Service Providers
In the course of the Company’s normal business operations, it has agreements with contract service providers to assist in the performance of its research and development, clinical research and manufacturing. Substantially all of these contracts are on an as needed basis.
15
10. License and Other Agreements
Bausch + Lomb
On October 22, 2019, the Company entered into a License Agreement (as amended, the "Bausch License Agreement") with Bausch + Lomb (“Bausch”). Pursuant to the Bausch License Agreement, the Company has granted an exclusive license to Bausch to develop, manufacture, distribute, promote, market and commercialize XIPERE using the Company’s proprietary SCS Microinjector (the “Device”), as well as specified other steroids, corticosteroids and NSAIDs in combination with the Device (together with XIPERE, the “Products”), subject to specified exceptions, in the United States and Canada (the “Territory”) for the treatment of ophthalmology indications, including non-infectious uveitis.
Pursuant to the Bausch License Agreement, Bausch paid the Company an aggregate of $
The Company was responsible for all development expenses for XIPERE in the Territory until the Company's New Drug Application ("NDA") was approved by the U.S. Food and Drug Administration ("FDA"), subject to specified exceptions, as well as manufacturing costs in connection with the NDA. The Company was also responsible for all clinical and development expenses conducted to satisfy the FDA’s requests in the complete response letter issued on October 18, 2019 related to the NDA. Following FDA approval of XIPERE, which occurred in October 2021, Bausch is responsible for all such expenses.
Arctic Vision (Hong Kong) Limited
On March 10, 2020, the Company entered into a License Agreement (the “Arctic License Agreement”) with Arctic Vision (Hong Kong) Limited (“Arctic Vision”). Pursuant to the Arctic License Agreement, the Company has granted an exclusive license to Arctic Vision to develop, distribute, promote, market and commercialize XIPERE, subject to specified exceptions, in China, Hong Kong, Macau, Taiwan and South Korea (the “Arctic Territory”). Under the terms of the Arctic License Agreement, neither party may commercialize XIPERE in the other party’s territory. Arctic Vision has agreed to use commercially reasonable efforts to pursue the development and commercialization of XIPERE for indications associated with uveitis in the Arctic Territory. In addition, upon receipt of the Company’s consent, Arctic Vision will have the right, but not the obligation, to develop and commercialize XIPERE for additional indications in the Arctic Territory.
Pursuant to the Arctic License Agreement, Arctic Vision has paid the Company an aggregate of $
In August 2021, the Company entered into an amendment to the Arctic License Agreement to expand the territories covered by the license to include India and the ASEAN Countries (Brunei, Cambodia, Indonesia, Laos, Malaysia, Myanmar, the Philippines, Singapore, Thailand, and Vietnam). In September 2021, the Company entered into a second amendment to the Arctic Vision License Agreement to expand the Arctic Territory to include Australia and New Zealand. The Company received an aggregate of $
BioCryst Pharmaceuticals, Inc.
On November 1, 2023, the Company entered into the BioCryst License Agreement pursuant to which the Company granted BioCryst an exclusive, worldwide and sublicensable license to the Company’s SCS Microinjector for the delivery of BioCryst’s proprietary plasma kallikrein inhibitor known as avoralstat for the treatment and prevention of diabetic macular edema.
The Company received an upfront license fee payment of $
16
billion, subject to reductions in specified circumstances. The Company's rights to these royalties and milestone payments have been sold pursuant to the terms and conditions of the Purchase and Sale Agreement described in Note 5.
BioCryst will be responsible for all development, regulatory and commercialization activities for avoralstat. The Company is responsible for supplying SCS Microinjectors to meet BioCryst’s reasonable needs.
Other
The Company periodically enters into short-term agreements with other customers to evaluate the potential use of its proprietary SCS Microinjector with third-party product candidates for the treatment of various diseases. Funds received from these agreements are recognized as revenue over the term of the agreement.
11. Fair Value Measurements
The Company’s material financial instruments at September 30, 2025 and December 31, 2024 consisted of cash and cash equivalents. The fair values of cash and cash equivalents, other current assets and accounts payable approximate their respective carrying values due to the short term nature of these instruments and are classified as Level 1 in the fair value hierarchy. The fair value of the warrant liabilities (see Note 7) require significant unobservable inputs and is classified as Level 3 in the fair value hierarchy.
There were
12. Related Party Transactions
A member of the Company's Board of Directors was the chief executive officer of a company that is a vendor of the Company until January 2025. As of December 31, 2024, the Company has recorded $
The chair of the board of directors of BioCryst also serves on the Company’s Board of Directors. The Company has recorded $
A former member of the Company's Board of Directors is the chief financial officer of Aura Biosciences. The Company has recorded $
13. Net Loss Per Share
Basic net loss per share is calculated by dividing the net loss by the weighted average number of shares of common stock outstanding for the period, without consideration of the dilutive effect of potential common stock equivalents. Diluted net loss per share gives effect to all dilutive potential shares of common stock outstanding during this period. For all periods presented, the Company’s potential common stock equivalents, which included stock options, restricted stock units and common stock warrants, have been excluded from the computation of diluted net loss per share as their inclusion would have the effect of reducing the net loss per share. Therefore, the denominator used to calculate both basic and diluted net loss per share is the same in all periods presented.
The Company’s potential common stock equivalents that have been excluded from the computation of diluted net loss per share for all periods presented because of their antidilutive effect consisted of the following:
|
|
Nine Months Ended |
|
|||||
|
|
2025 |
|
|
2024 |
|
||
Outstanding stock options |
|
|
|
|
|
|
||
Non-vested restricted stock units |
|
|
|
|
|
|
||
Common stock warrants |
|
|
|
|
|
|
||
|
|
|
|
|
|
|
||
17
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations.
Certain statements contained in this Quarterly Report on Form 10-Q may constitute forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. The words or phrases “would be,” “will allow,” “intends to,” “will likely result,” “are expected to,” “will continue,” “is anticipated,” “estimate,” “project,” or similar expressions, or the negative of such words or phrases, are intended to identify “forward-looking statements.” We have based these forward-looking statements on our current expectations and projections about future events. Because such statements include risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Factors that could cause or contribute to these differences include those below and elsewhere in this Quarterly Report on Form 10-Q and our other filings with the Securities and Exchange Commission, or SEC, under the heading “Risk Factors”. Statements made herein are as of the date of the filing of this Form 10-Q with the SEC and should not be relied upon as of any subsequent date. Unless otherwise required by applicable law, we do not undertake, and we specifically disclaim, any obligation to update any forward-looking statements to reflect occurrences, developments, unanticipated events or circumstances after the date of such statement.
The following discussion and analysis of our financial condition and results of operations should be read in conjunction with our unaudited consolidated financial statements and related notes that appear in Item 1 of this Quarterly Report on Form 10-Q and with our audited consolidated financial statements and related notes for the year ended December 31, 2024 appearing in our Annual Report on Form 10-K filed with the SEC on March 27, 2025.
Overview
We are a biopharmaceutical company focused on revolutionizing the delivery of therapies to the back of the eye into the suprachoroidal space, or SCS®. Our novel SCS injection platform, utilizing our proprietary SCS Microinjector®, enables an in-office, repeatable, non-surgical procedure for the targeted and compartmentalized delivery of a wide variety of therapies to all layers of the posterior segment of the eye to potentially preserve and improve vision in patients with sight-threatening eye diseases. Our SCS injection platform can be used in conjunction with existing drugs designed for delivery to the SCS, novel therapies and future therapeutic innovations. We believe our proprietary suprachoroidal administration platform has the potential to become a standard for delivery of therapies intended to treat chorioretinal diseases.
We are leveraging our SCS injection platform with an internal research and development pipeline targeting chorioretinal diseases and through external collaborations with other companies. We have our own pipeline of small molecule product candidates for administration via our SCS Microinjector, and we also strategically partner with companies developing other ophthalmic therapeutic innovations to be administered using our SCS injection technology. Our first product, XIPERE® (triamcinolone acetonide injectable suspension) for suprachoroidal use, was approved by the U.S. Food and Drug Administration, or the FDA, in October 2021. Approval of XIPERE was a significant milestone for us as it is the first approved therapeutic delivered into the SCS, the first commercial product developed by us and the first therapy for macular edema associated with uveitis.
Commercial Product
XIPERE® (triamcinolone acetonide injectable suspension) for suprachoroidal use, was approved by the FDA in October 2021. XIPERE is the first approved therapeutic delivered into the SCS, the first commercial product developed by us and the first therapy for macular edema associated with uveitis. XIPERE commercialization rights are licensed to Bausch + Lomb in the United States and Canada and Arctic Vision in the Asia Pacific region, not including Japan. In July 2025, Health Canada granted approval for XIPERE for the treatment of uveitic macular edema.
Operating Outlook and Strategic Review
We have incurred net losses since our inception. In recent years, our operations have consisted primarily of conducting preclinical studies and clinical trials, raising capital and undertaking other research and development initiatives. To date, we have primarily generated revenue through upfront payments and milestone payments related to license agreements and from collaboration agreements, and we have primarily financed our operations through public offerings and private placements of our equity securities, issuance of warrants, issuances of convertible promissory notes and loan agreements. As of September 30, 2025, we had an accumulated deficit of 374.0 million. We recorded net losses of $6.0 million and $7.7 million for the three months ended September 30, 2025 and 2024, respectively, and net losses of $18.7 million and $27.0 million for the nine months ended September 30, 2025 and 2024, respectively.
In July 2025, we announced plans to explore a full range of strategic alternatives to advance our SCS platform and drug development pipeline to maximize stockholder value. We have retained Piper Sandler, a leading investment bank with substantial experience in the biotechnology industry, to support us with the strategic evaluation process. Strategic alternatives under consideration include the sale, license, monetization and/or divestiture of one or more of our assets and technologies, collaboration, partnership,
18
merger, acquisition, joint ventures or other strategic transactions. If a strategic alternative is not available, we will be required to take additional actions to fund our operations, or we may be forced to file for bankruptcy or wind down our operations.
Based on our current plans and forecasted expenses and our cash and cash equivalents, we do not believe we will be able to fund our operations for the next 12 months from the date of this filing. These factors raise substantial doubt regarding our ability to continue as a going concern. Our consolidated financial statements have been prepared on a going concern basis, which contemplates the realization of assets and satisfaction of liabilities in the normal course of business. The consolidated financial statements do not include any adjustments to reflect the possible future effects on the recoverability and classification of recorded asset amounts or the amounts and classification of liabilities that might result should we be unable to continue as a going concern.
Macroeconomic Conditions
Unfavorable conditions in the economy in the United States and abroad may negatively affect the growth of our business and our results of operations. For example, macroeconomic events, rising inflation, the U.S. Federal Reserve raising interest rates, and conflicts in Ukraine, Russia and the Middle East have led to economic uncertainty globally. The effect of macroeconomic conditions may not be fully reflected in our results of operations until future periods. If, however, economic uncertainty increases or the global economy worsens, our business, financial condition and results of operations may be harmed. For further discussion of the potential impacts of macroeconomic events on our business, financial condition, and operating results, see “Risk Factors” included in Part I, Item 1A of the Annual Report on Form 10-K filed with the SEC on March 27, 2025.
Components of Operating Results
License and Other Revenue
We have not generated any revenue from the sale of XIPERE and we do not expect to generate any other product revenue unless or until we obtain regulatory approval for and commercialize our other product candidates, either on our own or with a third party. The revenue received under the Bausch license agreement, as well as other certain payments from our licensees, will be recorded as non-cash revenue until we have fulfilled our obligations under the Purchase and Sale Agreement. Our revenue in recent years has been generated primarily from our license agreements. We are seeking to enter into additional licenses and other agreements with third parties to evaluate the potential use of our proprietary SCS Microinjector with the third party’s product candidates for the treatment of various eye diseases. These agreements may include payments to us for technology access, upfront license payments, regulatory and commercial milestone payments and royalties.
Costs of Goods Sold
Cost of goods sold are related to the sales of our SCS Microinjector kits to our licensees for approved products.
Research and Development
Research and development expenses have historically consisted primarily of costs incurred for the research and development of our preclinical and clinical product candidates, which include:
We expense research and development costs to operations as incurred. These costs include preclinical activities, such as manufacturing and stability and toxicology studies, that are supportive of a product candidate itself. In addition, there are expenses related to clinical trials and similar activities for each program, including costs associated with CROs. Clinical costs are recognized based on the terms of underlying agreements, as well as an evaluation of the progress to completion of specific tasks using data such as participant enrollment, clinical site activations and additional information provided to us by our vendors about their actual costs
19
incurred. Expenses related to activities that support more than one development program or activity, such as salaries, share-based compensation and depreciation, are not classified as direct preclinical costs or clinical costs and are separately classified as unallocated.
The following table shows our research and development expenses by program for the three and nine months ended September 30, 2025 and 2024 (in thousands).
|
|
Three Months Ended |
|
|
Nine Months Ended |
|
||||||||||
|
|
2025 |
|
|
2024 |
|
|
2025 |
|
|
2024 |
|
||||
CLS-AX (wet AMD program) |
|
$ |
25 |
|
|
$ |
942 |
|
|
$ |
688 |
|
|
$ |
4,963 |
|
GA (geographic atrophy) |
|
|
58 |
|
|
|
53 |
|
|
|
523 |
|
|
|
53 |
|
Total |
|
|
83 |
|
|
|
995 |
|
|
|
1,211 |
|
|
|
5,016 |
|
Unallocated |
|
|
2,850 |
|
|
|
3,133 |
|
|
|
7,769 |
|
|
|
9,330 |
|
Total research and development expense |
|
$ |
2,933 |
|
|
$ |
4,128 |
|
|
$ |
8,980 |
|
|
$ |
14,346 |
|
Our expenses related to clinical trials are based on estimates of participant enrollment and related expenses at clinical investigator sites as well as estimates for the services received and efforts expended under contracts with research institutions, consultants and CROs that conduct and manage clinical trials on our behalf. We generally accrue expenses related to clinical trials based on contracted amounts applied to the level of participant enrollment and activity according to the protocol. If future timelines or contracts are modified based upon changes in the clinical trial protocol or scope of work to be performed, we would modify our estimates of accrued expenses accordingly on a prospective basis.
As discussed in more detail under “—Operating Outlook and Strategic Review” above, in July 2025, we announced plans to explore a full range of strategic alternatives to advance our SCS platform and drug development pipeline to maximize stockholder value. We paused all internal research and development programs during the pendency of this process. Accordingly, we expect research and development expenses will continue to decrease in future periods relative to the corresponding periods of 2024.
General and Administrative
General and administrative expenses consist primarily of salaries and other related costs, including share-based compensation, for personnel in executive, finance and administrative functions. General and administrative costs historically included commercial pre-launch preparations for XIPERE, and also include facility related costs not otherwise included in research and development expenses, as well as professional fees for legal, patent, consulting, and accounting and audit services.
Interest Income
Interest income consists of the accrued interest and interest income earned on our cash and cash equivalents.
Other Income, Net
Other income, net consists of expenses allocated to the warrants issued in connection with our registered direct offering in February 2024 and the change in fair value of the warrants during the periods.
Non-cash Interest Expense on Liability Related to the Sales of Future Royalties
Non-cash interest expense on liability related to the sales of future royalties consists of imputed interest on the carrying value of the liability and the amortization of the related issuance costs.
Income Tax Expense
Income tax expense consists of taxes incurred in foreign jurisdictions.
Critical Accounting Policies and Significant Judgments and Estimates
Our management’s discussion and analysis of our financial condition and results of operations is based on our consolidated financial statements, which have been prepared in accordance with U.S. generally accepted accounting principles or U.S. GAAP. The preparation of these consolidated financial statements requires us to make estimates, judgments and assumptions that affect the reported amounts of assets and liabilities, disclosure of contingent assets and liabilities as of the dates of the consolidated balance sheets and the reported amounts of expenses during the reporting periods. In accordance with U.S. GAAP, we evaluate our estimates and judgments on an ongoing basis. Significant estimates include certain assumptions used in royalty financing obligation, certain assumptions used in the valuation of warrant liabilities and certain assumptions used to estimate research and development expenses, including clinical trials. We base our estimates on historical experience and on various other factors that we believe are reasonable under the circumstances, the results of which form the basis for making judgments about the carrying value of assets and liabilities
20
that are not readily apparent from other sources. Actual results may differ from these estimates under different assumptions or conditions.
We define our critical accounting policies, in accordance with U.S. GAAP, as those that require us to make subjective estimates and judgments about matters that are uncertain and are likely to have a material impact on our financial condition and results of operations, as well as the specific manner in which we apply those principles. During the nine months ended September 30, 2025, there were no significant changes to our critical accounting policies disclosed in our audited consolidated financial statements for the year ended December 31, 2024, which are included in our Annual Report on Form 10-K, as filed with the SEC on March 27, 2025.
Results of Operations for the Three Months Ended September 30, 2025 and 2024
The following table sets forth our results of operations.
|
|
Three Months Ended |
|
|
Period-to-Period |
|
||||||
|
|
2025 |
|
|
2024 |
|
|
Change |
|
|||
|
|
(in thousands) |
|
|||||||||
License and other revenue |
|
$ |
201 |
|
|
$ |
1,038 |
|
|
$ |
(837 |
) |
Operating expenses: |
|
|
|
|
|
|
|
|
|
|||
Research and development |
|
|
2,933 |
|
|
|
4,128 |
|
|
|
(1,195 |
) |
General and administrative |
|
|
4,308 |
|
|
|
2,844 |
|
|
|
1,464 |
|
Total operating expenses |
|
|
7,241 |
|
|
|
6,972 |
|
|
|
269 |
|
Loss from operations |
|
|
(7,040 |
) |
|
|
(5,934 |
) |
|
|
(1,106 |
) |
Interest income |
|
|
65 |
|
|
|
338 |
|
|
|
(273 |
) |
Other income, net |
|
|
3,573 |
|
|
|
365 |
|
|
|
3,208 |
|
Non-cash interest expense on liability |
|
|
(2,570 |
) |
|
|
(2,457 |
) |
|
|
(113 |
) |
Net loss |
|
|
(5,972 |
) |
|
|
(7,688 |
) |
|
|
1,716 |
|
License and other revenue. In the three months ended September 30, 2025 and 2024, we recognized $0.2 million and $1.0 million, respectively, of revenue associated with our license agreements. License revenue and other revenue for the three months ended September 30, 2025 consisted of revenue for training and services. License revenue and other revenue for the three months ended September 30, 2024 consisted of revenue for training, services and the sales of our SCS Microinjector kits to our licensees.
Research and development. Research and development expenses decreased by $1.2 million from $4.1 million for the three months ended September 30, 2024 to $2.9 million for the three months ended September 30, 2025. This decrease was primarily due to a $0.9 million decrease in costs related to the CLS-AX program due to the completion of ODYSSEY, our Phase 2b clinical trial and a $1.2 million increase in employee related severance costs due to the reduction in force, partially offset by a $1.4 million decrease in salary and other related benefits.
General and administrative. General and administrative expenses increased by $1.5 million from $2.8 million for the three months ended September 30, 2024 to $4.3 million for the three months ended September 30, 2025. This increase was primarily due to a $1.1 million increase in professional services, a $1.1 million increase in employee related severance costs due to the reduction in force and a $0.6 million increase in consulting fees, partially offset by a $0.9 million decrease in salary and other related benefits.
Interest income. Interest income decreased by $0.3 million from $0.3 million for the three months ended September 30, 2024 to $65,000 for the three months ended September 30, 2025. The decrease was due to the lower balance of our cash and cash equivalents.
Other income, net. Other income, net was $3.6 million for the three months ended September 30, 2025 and $0.4 million for the three months ended September 30, 2024. The change was due to a larger decline in the fair value of the warrant liabilities from the December 31, 2024 valuation date to September 30, 2025 than as compared to the decline in fair value from the February 2024 issuance date to September 30, 2024.
Non-cash interest expense on liability related to the sales of future royalties. Non-cash interest expense on liability related to the sales of future royalties was $2.6 million and $2.5 million for the three months ended September 30, 2025 and 2024, respectively, and was comprised of imputed interest on the liability related to the sales of future royalties and the amortization of the associated issuance costs.
21
Results of Operations for the Nine Months Ended September 30, 2025 and 2024
The following table sets forth our results of operations.
|
|
Nine Months Ended |
|
|
Period-to-Period |
|
||||||
|
|
2025 |
|
|
2024 |
|
|
Change |
|
|||
|
|
(in thousands) |
|
|||||||||
License and other revenue |
|
$ |
3,023 |
|
|
$ |
1,358 |
|
|
$ |
1,665 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|||
Cost of goods sold |
|
|
248 |
|
|
|
— |
|
|
|
248 |
|
Research and development |
|
|
8,980 |
|
|
|
14,346 |
|
|
|
(5,366 |
) |
General and administrative |
|
|
9,608 |
|
|
|
8,745 |
|
|
|
863 |
|
Total operating expenses |
|
|
18,836 |
|
|
|
23,091 |
|
|
|
(4,255 |
) |
Loss from operations |
|
|
(15,813 |
) |
|
|
(21,733 |
) |
|
|
5,920 |
|
Interest income |
|
|
343 |
|
|
|
1,104 |
|
|
|
(761 |
) |
Other income, net |
|
|
5,500 |
|
|
|
783 |
|
|
|
4,717 |
|
Non-cash interest expense on liability |
|
|
(8,005 |
) |
|
|
(7,200 |
) |
|
|
(805 |
) |
Loss before income taxes |
|
|
(17,975 |
) |
|
|
(27,046 |
) |
|
|
9,071 |
|
Income tax expense |
|
|
715 |
|
|
|
— |
|
|
|
715 |
|
Net loss |
|
$ |
(18,690 |
) |
|
$ |
(27,046 |
) |
|
$ |
8,356 |
|
License and other revenue. In the nine months ended September 30, 2025 and 2024, we recognized $3.0 million and $1.4 million, respectively, of revenue associated with our license agreements. License revenue and other revenue for the nine months ended September 30, 2025 consisted of $1.5 million in milestones from Arctic Vision and $1.5 million in other revenue for training, services and the sales of our SCS Microinjector kits to our licensees. License revenue and other revenue for the nine months ended September 30, 2024 consisted of $1.4 million for training, services and the sales of our SCS Microinjector kits to our licensees.
Cost of goods sold. In the nine months ended September 30, 2025, we recognized $0.2 million in cost of goods sold related to the sales of our SCS Microinjector kits to our licensees of approved products.
Research and development. Research and development expenses decreased by $5.4 million from $14.3 million for the nine months ended September 30, 2024 to $9.0 million for the nine months ended September 30, 2025. This decrease was primarily due to a $4.3 million decrease in costs related to the CLS-AX program due to the completion of ODYSSEY, our Phase 2b clinical trial, a $0.7 million decrease in employee related costs due to the reduction in force and $0.4 million decrease related to a research and development tax credit received in the nine months ended September 30, 2025. This decrease was partially offset by a $0.5 million increase in costs related to the GA program.
General and administrative. General and administrative expenses increased by $0.9 million from $8.7 million for the nine months ended September 30, 2024 to $9.6 million for the nine months ended September 30, 2025. This increase was primarily due to a $1.4 million increase in professional fees, $0.8 million increase in consulting fees and a $0.5 million increase in employee related costs due to the reduction in force. This is partially offset by a $0.5 million decrease in patent expense.
Interest income. Interest income decreased by $0.8 million from $1.1 million for the nine months ended September 30, 2024 to $0.3 million for the nine months ended September 30, 2025. The decrease was due to the lower balance of our cash and cash equivalents.
Other income, net. Other income, net was $5.5 million for the nine months ended September 30, 2025 and $0.8 million for the nine months ended September 30, 2024. The change was due to a larger decline in in the fair value of the warrant liabilities from the December 31, 2024 valuation date to September 30, 2025 than as compared to the decline in fair value from the February 2024 issuance date to September 30, 2024.
Non-cash interest expense on liability related to the sales of future royalties. Non-cash interest expense on liability related to the sales of future royalties was $8.0 million and $7.2 million for the nine months ended September 30, 2025 and 2024, respectively, and was comprised of imputed interest on the liability related to the sales of future royalties and the amortization of the associated issuance costs.
Income tax expense. Income tax expense is due to taxes on milestone revenue incurred in foreign jurisdictions.
22
Liquidity and Capital Resources
Sources of Liquidity
We have funded our operations primarily through the proceeds of public offerings of our common stock, sales of convertible preferred stock, issuance of warrants and the issuance of long-term debt. As of September 30, 2025, we had cash and cash equivalents of $6.8 million. We invest any cash in excess of our immediate requirements primarily with a view to liquidity and capital preservation. As of September 30, 2025, our funds were held in cash and money market funds.
On September 4, 2025, we entered into an Omnibus Amendment Agreement, or the Amendment, with Clearside Royalty LLC, a wholly owned subsidiary of the Company, or the Seller, Healthcare Royalty Partners IV, L.P., or the Purchaser, and HCR Clearside SPV, LLC, or the Purchaser Agent. The Amendment, among other things, amends (i) the Purchase and Sale Agreement, dated as of August 8, 2022, or the Purchase and Sale Agreement, by and among the Seller, the Purchaser and the Purchaser Agent, (ii) the Contribution and Servicing Agreement, dated August 8, 2022, as amended to date, by and between us and Seller and (iii) the Pledge and Security Agreement, dated as of August 8, 2022, as amended to date, by and between the Company and the Purchaser Agent.
Pursuant to the Purchase and Sale Agreement, in August 2022, the Seller sold to Purchaser certain of its rights to receive royalty and milestone payments payable to Seller under existing license agreements related to XIPERE (triamcinolone acetonide injectable suspension) or our SCS Microinjector technology (collectively, the “Royalties”), and the Seller received $32.5 million. Pursuant to the Pledge Agreement, we pledged the capital stock of the Seller to secure the obligations of the Seller under the Purchase and Sale Agreement. Purchaser Agent is entitled to foreclose on such capital stock following the occurrence of certain events.
Pursuant to the Amendment, the Seller received an additional $3.0 million from the Purchaser, which the Seller then paid to us in exchange for the remaining assets related to our SCS Microinjector technology. In addition, in exchange for the additional transferred assets, the Purchaser also agreed to (i) reduce the amount of aggregate Royalties required for the Purchase and Sale Agreement to expire, and the payment of Royalties from the Royalty Sub to the Purchaser to cease, from $110.5 million to $106.5 million, (ii) specified exceptions to its right to receive change of control payments and (iii) a waiver of its right to foreclose on the capital stock of the Seller in specified circumstances.
On February 6, 2024, we entered into a securities purchase agreement, pursuant to which we issued and sold, in a registered direct offering: (i) an aggregate of 740,740 shares of our common stock; and (ii) warrants to purchase up to 740,740 shares of common stock, or Warrants. The combined purchase price of each share and accompanying Warrant was $20.25. The exercise price for the Warrants is $24.30 per share. The Warrants are currently exercisable and will expire on August 9, 2029. The net proceeds to us from the registered direct offering were $13.9 million.
On January 31, 2024, or the Amendment Effective Date, we entered into a fourth amendment to the license agreement, or the Emory License Agreement, with Emory University and Georgia Tech Research Corporation, or, collectively, the Licensor, pursuant to which the parties agreed to reduce the Sublicense Percentage (as defined in the Emory License Agreement) from a low double digit percentage to a high single digit percentage that we will pay the Licensor applicable to any fees or payments paid to us by any Sublicensee (as defined in the Emory License Agreement) of the Licensed Patents and/or Licensed Technology (each as defined in the Emory License Agreement), excluding (i) amounts paid to us by a Sublicensee to reimburse us for certain research and development costs pursuant to a written agreement between us and such Sublicensee, (ii) the value of intellectual property transferred or granted to us if necessary or helpful to the development or commercialization of Licensed Products (as defined in the Emory License Agreement) and (iii) amounts paid for shares of our stock. The payment to Licensor of any such Sublicense Percentage is due within 30 days of receipt by us of a qualifying payment from a Sublicensee, provided however, with respect to any qualifying payments received by us from a Sublicensee prior to January 1, 2025, the payment to Licensor of any such Sublicensee Percentage is due to Licensor by March 31, 2025. The parties also agreed to a revised annual license maintenance fee due each year, or the Maintenance Fee, starting in 2023 through 2028, as follows: $0.3 million for 2023 through 2025, $0.4 million for each of 2026 and 2027 and $0.5 million for 2028. The remaining annual Maintenance Fee payments are due on October 1st of each year.
In May 2023, we entered into a Controlled Equity OfferingSM Sales Agreement, or the Sales Agreement, with Cantor Fitzgerald & Co., or Cantor, under which we may offer and sell, from time to time at our sole discretion, shares of our common stock, having an aggregate offering price of up to $50.0 million through Cantor as our sales agent. During the nine months ended September 30, 2025, we sold 109,957 shares of our common stock for net proceeds of $1.4 million under the Sales Agreement. During the nine months ended September 30, 2024, we sold 22,656 shares of our common stock for net proceeds of $0.5 million under the Sales Agreement.
Funding Requirements
Our primary uses of capital are, and we expect will continue to be, compensation and related expenses, research and development costs to build our product candidate pipeline, legal and other regulatory expenses and general overhead costs as we explore strategic alternatives. In addition, we have certain contractual obligations for future payments. Refer to Note 5 to our consolidated financial statements included in this Quarterly Report on Form 10-Q.
23
The successful development of our product candidates is highly uncertain. As such, at this time, we cannot reasonably estimate or know the nature, timing and estimated costs of the efforts that will be necessary to complete the remainder of the development of CLS-AX or any future product candidates. We are also unable to predict when, if ever, material net cash inflows will commence from product sales. This is due to the numerous risks and uncertainties associated with developing drugs, including the uncertainty of:
A change in the outcome of any of these variables with respect to the development of any of our product candidates would significantly change the costs and timing associated with the development of that candidate.
Until such time, if ever, as we can generate substantial product revenue, we may seek to finance our cash needs through a combination of equity offerings, debt financings and potential collaboration, license and development agreements. Other than potential payments we may receive under our license and other agreements, we do not currently have any committed external source of funds, though, as described above, we may also be able to sell our common stock under the Sales Agreement subject to the terms of that agreement and depending on market conditions. We expect that we will require additional capital to fund our ongoing operations. Additional funds may not be available to us on a timely basis, on commercially reasonable terms, or at all. Our ability to raise additional capital may be adversely impacted by potential worsening global economic conditions and disruptions to, and volatility in, the credit and financial markets in the United States and worldwide and related macroeconomic changes, such as rising inflation. To the extent that we raise additional capital through the sale of equity or convertible debt securities, your ownership interest will be diluted, and the terms of these securities may include liquidation or other preferences that adversely affect your rights as a common stockholder. Debt financing and 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 funds through additional collaborations, strategic alliances or marketing, distribution or licensing arrangements with third parties, including any future collaboration or licensing arrangement for XIPERE outside of the territories in which we have previously licensed or granted options to license XIPERE, we may be required to relinquish additional rights to our technologies, future revenue streams, research programs or product candidates or to 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 drug development or future commercialization efforts or grant rights to develop and market product candidates that we would otherwise prefer to develop and market ourselves.
We also incur costs as a public company, including costs and expenses for fees to members of our board of directors, accounting and finance personnel costs, directors and officers insurance premiums, audit and legal fees, investor relations fees and expenses for compliance with reporting requirements under the Exchange Act and rules implemented by the SEC and Nasdaq.
Outlook
We have suffered recurring losses and negative cash flows from operations since inception and anticipate incurring additional losses until such time, if ever, that we can generate significant milestone payments and royalties from XIPERE and other licensing arrangements or revenues from other product candidates. We will need additional financing to fund our operations. Our plans primarily consist of raising additional capital, potentially in a combination of equity or debt financings, monetizing royalties, or restructurings, or potentially entering into additional collaborations, partnerships and other strategic arrangements.
Based on our current plans and forecasted expenses, including the impact of our recent announcement to explore strategic alternatives, we do not believe our cash and cash equivalents will be able to fund our operations for the next 12 months from the date of this filing. In order to conserve our cash balance we have paused all internal research and development programs which can be resumed if we are able to raise additional capital.
These factors raise substantial doubt regarding our ability to continue as a going concern. Our consolidated financial statements have been prepared on a going concern basis, which contemplates the realization of assets and satisfaction of liabilities in the normal course of business. The consolidated financial statements do not include any adjustments to reflect the possible future effects on the recoverability and classification of recorded asset amounts or the amounts and classification of liabilities that might result should we be unable to continue as a going concern.
24
Cash Flows
The following is a summary of the net cash flows (used in) provided by our operating, investing and financing activities (in thousands):
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Nine Months Ended |
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|||||
|
|
2025 |
|
|
2024 |
|
||
Net cash (used in) provided by: |
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|
|
|
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||
Operating activities |
|
$ |
(16,039 |
) |
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$ |
(19,444 |
) |
Investing activities |
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|
(9 |
) |
|
|
(9,945 |
) |
Financing activities |
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|
2,829 |
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|
|
14,357 |
|
Net change in cash and cash equivalents |
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$ |
(13,219 |
) |
|
$ |
(15,032 |
) |
During the nine months ended September 30, 2025 and 2024, our operating activities used net cash of $16.0 million and $19.4 million, respectively. The net cash used in operating activities for the nine months ended September 30, 2025 was due to ongoing research and development expenses to develop our pipeline, general and administrative costs and $2.3 million in severance and related costs was paid to employees due to the reduction in force. The net cash used in operating activities for the nine months ended September 30, 2024 was due to ongoing research and development expenses to develop our pipeline and costs for ODYSSEY, as well as the supporting general and administrative costs.
During the nine months ended September 30, 2025 and 2024, our investing activities used net cash of $9,000 and $9.9 million, respectively. The net cash used in investing activities for the nine months ended September 30, 2025 consisted of the acquisition of property and equipment. The net cash used in investing activities for the nine months ended September 30, 2024 consisted of $16.9 million for the purchase of short-term investments and $0.5 million for the acquisition of property and equipment, partially offset by $7.5 million received upon the maturity of short-term investments.
During the nine months ended September 30, 2025 and 2024, our financing activities provided net cash of $2.8 million and $14.3 million, respectively. The net cash provided by financing activities for the nine months ended September 30, 2025 consisted primarily of $2.9 million of net proceeds from the Purchase and Sale Agreement and proceeds of $1.4 million from the sale of shares of our common stock under the Sales Agreement. This is partially offset by $1.5 million payment related to the royalty purchase and sale agreement. The net cash provided by financing activities for the nine months ended September 30, 2024 consisted primarily of $13.9 million of net proceeds from the sale of shares of our common stock and warrants in a registered direct offering and $0.5 million of net proceeds from the sale of shares of our common stock under the Sales Agreement.
Item 3. Quantitative and Qualitative Disclosures about Market Risk
We are a smaller reporting company as defined by Rule 12b-2 of the Exchange Act and are not required to provide the information required under this item.
Item 4. Controls and Procedures
Evaluation of Disclosure Controls and Procedures
The term “disclosure controls and procedures,” as defined in Rules 13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934, as amended (the “Exchange Act”), refers to controls and procedures that are designed to ensure that information required to be disclosed by a company in the reports that it files or submits under the Exchange Act is recorded, processed, summarized and reported, within the time periods specified in the SEC’s rules and forms. Disclosure controls and procedures include, without limitation, controls and procedures designed to ensure that such information is accumulated and communicated to a company’s management, including its principal executive and principal financial officers, as appropriate to allow timely decisions regarding required disclosure.
In designing and evaluating our disclosure controls and procedures, management recognizes that disclosure controls and procedures, no matter how well conceived and operated, can provide only reasonable, not absolute, assurance that the objectives of the disclosure controls and procedures are met. Additionally, in designing disclosure controls and procedures, our management necessarily was required to apply its judgment in evaluating the cost-benefit relationship of possible disclosure controls and procedures. The design of any system of controls also is based in part upon certain assumptions about the likelihood of future events, and there can be no assurance that any design will succeed in achieving its stated goals under all potential future conditions; over time, controls may become inadequate because of changes in conditions, or the degree of compliance with policies or procedures may deteriorate. Because of the inherent limitations in a control system, misstatements due to error or fraud may occur and not be detected.
Our management, with the participation of our Chief Executive Officer and our Chief Financial Officer, has evaluated the effectiveness of our disclosure controls and procedures as of the end of the period covered by this report. Based on that evaluation, our
25
Chief Executive Officer and our Chief Financial Officer concluded that our disclosure controls and procedures were effective as of the end of the period covered by this report at the reasonable assurance level.
Changes in Internal Control over Financial Reporting
There has been no change in our internal control over financial reporting during the quarter ended September 30, 2025 that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting. We have not experienced any material impact to our internal control over financial reporting.
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PART II – OTHER INFORMATION
Item 1. Legal Proceedings
From time to time, we may be subject to litigation and claims arising in the ordinary course of business. We are not currently a party to any material legal proceedings and we are not aware of any pending or threatened legal proceeding against us that we believe could have a material adverse effect on our business, operating results, cash flows or financial condition.
Item 1A. Risk Factors
Our business is subject to risks and events that, if they occur, could adversely affect our financial condition and results of operations and the trading price of our securities. In addition to the other information set forth in this quarterly report on Form 10-Q, you should carefully consider the factors described in “Part I, Item 1A. Risk Factors” of our Annual Report on Form 10-K for the fiscal year ended December 31, 2024, filed with the Securities and Exchange Commission on March 27, 2025.
Risks Related to Our Financial Position, Capital Needs and Strategic Review
We do not currently have sufficient working capital to fund our planned operations for the next twelve months and substantial doubt exists as to our ability to continue as a going concern.
Our historical financial statements have been prepared under the assumption that we will continue as a going concern. As of September 30, 2025, we had an accumulated deficit of $374.0 million and had cash and cash equivalents of $6.8 million. While we have begun to implement cost reductions in 2025, we have finite cash resources available to fund our operations. As part of cost reductions, we implemented a plan pursuant to which we terminated all employees and transitioned such persons into consulting roles. We incurred charges of approximately $2.3 million for severance and other employee termination-related costs in the third quarter of 2025. The estimated charges that we expect to incur are subject to a number of assumptions, and actual results may differ materially from these estimates. We may also incur additional costs not currently contemplated due to events that may occur as a result of, or that are associated with, our workforce reduction. The reduction in force is expected to be completed during the third quarter of 2025.
In July 2025, we announced plans to explore a full range of strategic alternatives to advance our SCS platform and drug development pipeline to maximize stockholder value. We have retained Piper Sandler, a leading investment bank with substantial experience in the biotechnology industry, to support us with the strategic evaluation process. Strategic alternatives under consideration include the sale, license, monetization and/or divestiture of one or more of our assets and technologies, collaboration, partnership, merger, acquisition, joint ventures or other strategic transactions.
These conditions raise substantial doubt about our ability to continue as a going concern within one year after the date the financial statements are issued. Based on our current plans and forecasted expenses and our cash and cash equivalents, we do not believe we will be able to fund our operations for the next 12 months from the date of this filing. Until we can generate sufficient revenue, if ever, to fund our operations, we will need to finance future cash needs through public or private equity offerings, license agreements, debt financings or restructurings, collaborations, strategic alliances and marketing or distribution arrangements.
The perception of our ability to continue as a going concern may make it more difficult for us to obtain financing for the continuation of our operations and could result in the loss of confidence by investors and employees. Additional financing may not be available to us when needed or, if available, it may not be obtained on commercially reasonable terms. If we are not able to obtain the necessary additional financing and if a strategic alternative is not available, we may be forced to file for bankruptcy or wind down our operations.
Our activities to evaluate and pursue potential strategic alternatives may not result in any transaction or enhance stockholder value. If we do not successfully consummate a strategic alternative, our board of directors may decide to file for bankruptcy, wind down our operations, or pursue a dissolution and liquidation of our company. In such an event, the amount available for distribution to our common stockholders could be as low as zero and result in a total loss of investment to our stockholders.
We have begun evaluating and exploring a variety of strategic alternatives focused on maximizing stockholder value, including, but not limited to, an acquisition, merger, reverse merger, other business combination, sales of assets or other strategic transactions. Our ability to successfully execute on a strategic alternative is dependent on a number of factors and we may not be able to execute upon a transaction or other strategic alternative upon favorable terms within an advantageous timeframe and recognize significant value for our assets, if at all. Additionally, the negotiation and consummation of a transaction or other strategic alternative may be costly and time-consuming. Any executed strategic alternative may not maximize or even enhance stockholder value, could result in total costs and expenses that are greater than expected, could make it more difficult to attract and retain qualified personnel and may disrupt our operations, each of which could have a material adverse effect on our business.
The market price of our common stock may reflect a market assumption that a strategic alternative will occur, and a failure to complete a strategic alternative could result in negative investor perceptions and could cause a decline in the market price of our common stock, which could adversely affect our ability to access the equity and financial markets, as well as our ability to explore and
27
enter into different strategic alternatives. There can be no certainty that any strategic alternative will be completed, be on attractive terms, enhance stockholder value or deliver the anticipated benefits, and successful integration or execution of the strategic alternatives will be subject to additional risks. In addition, potential strategic alternatives that require stockholder approval may not be approved by our stockholders. If we do not successfully consummate a strategic alternative, our board of directors may decide to file for bankruptcy, wind down our operations, or pursue a dissolution and liquidation of our company. In such an event, the amount of cash available for distribution to our stockholders will depend heavily on the timing of such liquidation, the amount of cash that will need to be reserved for commitments and contingent liabilities. Depending on these factors, the amount available for distribution to our common stockholders could be as low as zero and result in a total loss of investment to our stockholders.
In the event we file for bankruptcy, we would be subject to the risks and uncertainties associated with such proceedings.
In the event we file for relief under the United States Bankruptcy Code, our operations and our continuation as a going concern will be subject to the risks and uncertainties associated with bankruptcy proceedings. Any delays in our bankruptcy proceedings would increase the risks of our being unable to reorganize our business and emerge from bankruptcy proceedings and may increase our costs associated with the bankruptcy process or result in prolonged operational disruption for us. Also, we would need the prior approval of the bankruptcy court for transactions outside the ordinary course of business during the course of any bankruptcy proceedings, which may limit our ability to respond timely to certain events or take advantage of certain opportunities. Because of the risks and uncertainties associated with any bankruptcy proceedings, we cannot accurately predict or quantify the ultimate impact of events that could occur during any such proceedings. There can be no guarantees that if we file for bankruptcy we will emerge from bankruptcy as a going concern or that holders of our common stock will receive any recovery from any bankruptcy proceedings.
Risks Related to Ownership of Our Common Stock
If we are unable to maintain listing of our common stock on Nasdaq or any stock exchange, our stock price could be adversely affected and the liquidity of our stock and our ability to obtain financing could be impaired and it may be more difficult for our stockholders to sell their securities.
Although our common stock is currently listed on Nasdaq, we may not be able to continue to meet the exchange’s minimum listing requirements or those of any other national exchange. The Listing Rules of Nasdaq require listing issuers to comply with certain standards in order to remain listed on its exchange. For example, on August 28, 2025, we received a notice from the Nasdaq notifying us that the listing of our common stock was not in compliance with the minimum Market Value of Listed Securities of $50,000,000 required for continued listing on The Nasdaq Global Market, as set forth in Nasdaq Listing Rule 5450(b)(2)(A), or the MVLS Requirement. We have a period of 180 calendar days, or until February 24, 2026, or the Compliance Date, to regain compliance with the MVLS Requirement. To regain compliance, our MVLS must close at $50,000,000 or more for a minimum of 10 consecutive business days prior to the Compliance Date. In the event we do not regain compliance with the MVLS Requirement prior to the Compliance Date, Nasdaq will notify us that our securities are subject to delisting, at which point we may appeal the delisting determination to a Nasdaq hearings panel.
If for any reason, we should fail to maintain compliance with these listing standards in the future and Nasdaq should delist our securities from trading on its exchange and we are unable to obtain listing on another national securities exchange, we anticipate that our securities would begin trading on the over-the-counter market. Delisting from Nasdaq and trading on the over-the-counter market could adversely affect the liquidity of our securities. Securities traded on the over-the-counter market generally have limited trading volume and exhibit a wider spread between the bid/ask quotation, as compared to securities listed on a national securities exchange. Consequently, you may not be able to liquidate your investment in the event of an emergency or for any other reason.
If Nasdaq delists our securities from trading on its exchange for failure to meet the listing standards, we and our stockholders could face significant negative consequences including limited availability of market quotations for our securities, a determination that the common stock is a “penny stock” which will require brokers trading in the common stock to adhere to more stringent rules, possibly resulting in a reduced level of trading activity in the secondary trading market for shares of the common stock, a limited amount of analyst coverage, and a decreased ability to issue additional securities or obtain additional financing in the future.
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Item 2. Unregistered Sales of Equity Securities and Use of Proceeds
Sales of Unregistered Securities
None.
Issuer Purchases of Equity Securities
None.
Item 5. Other Information
During the quarter ended September 30, 2025, none of our directors or officers (as defined in Rule 16a-1(f) under 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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Form 8-K (File No. 001-37783) filed with the SEC on June 7, 2016). |
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10.1 |
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10.2 |
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10.3 |
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10.4 |
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10.5 |
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10.6 |
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10.7*+ |
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31.1* |
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Certification of Principal Executive Officer under Section 302 of the Sarbanes-Oxley Act. |
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31.2* |
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Certification of Principal Financial Officer under Section 302 of the Sarbanes-Oxley Act. |
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32.1** |
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101.INS |
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Inline XBRL Instance Document |
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101.SCH |
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Inline XBRL Taxonomy Extension Schema Document with Embedded Linkbase Documents |
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104 |
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Cover Page Interactive Data File (formatted as inline XBRL and contained in Exhibits 101) |
* |
Filed herewith. |
+ |
Pursuant to Item 601(b)(10)(iv) of Regulation S-K promulgated by the Securities and Exchange Commission, certain portions of this exhibit (indicated by asterisks) have been omitted because they are not material and are the type that the Registrant treats as private or confidential. The Registrant hereby agrees to furnish supplementally to the Securities and Exchange Commission, upon its request, an unredacted copy of this exhibit. |
** |
These certifications are being furnished solely to accompany this quarterly report pursuant to 18 U.S.C. Section 1350, and are not being filed for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, and are not to be incorporated by reference into any filing of the registrant, whether made before or after the date hereof, regardless of any general incorporation language in such filing. |
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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
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Clearside Biomedical, Inc. |
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Date: November 14, 2025 |
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By: |
/s/ Charles A. Deignan |
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Charles A. Deignan |
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Chief Financial Officer |
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(On behalf of the Registrant and as |
31
Exhibit 10.7
CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***], HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) IS THE TYPE THAT THE REGISTRANT TREATS AS PRIVATE OR CONFIDENTIAL.
OMNIBUS AMENDMENT AGREEMENT
This OMNIBUS AMENDMENT AGREEMENT, dated as of September 4, 2025 (this “Agreement”) is entered into by and among Clearside Biomedical, Inc., a Delaware corporation (the “Company”), Clearside Royalty LLC, a Delaware limited liability company (the “Seller”), Healthcare Royalty Partners IV, L.P., a Delaware limited partnership (the “Purchaser”) and HCR Clearside SPV, LLC, a Delaware limited liability company (the “Purchaser Agent”). Capitalized terms used but not otherwise defined herein shall have the meanings ascribed thereto in the PSA (as defined below).
WHEREAS, the Seller, the Purchaser and the Purchaser Agent are parties to that certain Purchase and Sale Agreement, dated as of August 8, 2022 (as amended to date, the “PSA”), pursuant to which, among other things, the Purchaser acquired the Purchased Royalties from the Seller;
WHEREAS, immediately prior to the consummation of the transactions contemplated by the Purchase Agreement, the Company and the Seller entered into that certain Contribution and Servicing Agreement, dated August 8, 2022 (as amended to date, the “CSA”), pursuant to which, among other things, the Company transferred the Transferred Assets to the Seller and agreed to provide certain services to the Seller relating to the Transferred Assets;
WHEREAS, to secure the obligations of the Seller under the Purchase Agreement and the obligations of the Company under the Contribution Agreement, the Company and the Purchaser Agent entered into that certain Pledge and Security Agreement, dated as of August 8, 2022 (as amended to date, the “Pledge Agreement”), pursuant to which, among other things, the Company pledged the equity interests in the Seller to the Purchaser Agent, as agent for the Purchaser; and
WHEREAS, the Company, the Seller, the Purchaser and the Purchaser Agent desire to amend certain of the provisions of the PSA, the CSA and the Pledge Agreement to address certain additional agreements among the Parties and an additional investment by the Purchaser.
NOW THEREFORE, in consideration of the premises and mutual covenants, agreements representations and warranties set forth herein and of other good and valuable consideration, the receipt and adequacy of which are hereby acknowledged, the Parties agree as follows:
CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***], HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) IS THE TYPE THAT THE REGISTRANT TREATS AS PRIVATE OR CONFIDENTIAL.
“Additional Transferred Assets” means the assets described on Exhibit A to the Amendment Agreement.
“Amendment Payment” shall mean $3,000,000.
“Amendment Agreement” means that certain Omnibus Amendment Agreement, dated as of the Amendment Date, by and among Company, Product Sub, Purchaser and Purchaser Agent.
“Amendment Date” means September 4, 2025.
“Hard Cap Amount” means, at any given time, the product of (x) the Investment Amount and (y) 3.0.
“Investment Amount” shall mean the sum of (a) $35,500,000 (i.e., the sum of the Closing Payment and the Amendment Payment) and (b) the Purchaser Payment Amount (if any). For the avoidance of doubt, the Parties acknowledge that (i) the First Milestone Event and the Second Milestone Event were not achieved, and (ii) the First Milestone Payment and the Second Milestone Payment have not been paid and are not included in the “Investment Amount.”
Section 2.3 Change of Control Payment.
(a) Upon the occurrence of a Change of Control but subject to subsection (b), the Seller shall promptly pay to the Purchaser the Hard Cap Amount less the Total Net Amount as of such date (the “Change of Control Payment”); provided, however, that the Seller shall, in lieu of the foregoing, have the option to instead pay one hundred percent (100%) of the Investment Amount outstanding as of the date of such Change of Control, less the Total Net Amount as of such date (the “Buyout Option”). If the Seller exercises the Buyout Option, the Purchaser shall continue to be entitled to the amounts payable to the Purchaser solely from Purchased Royalties in the same manner, and on the same terms as in effect prior to the Change of Control, provided, however, that in the case of an acquisition of all or substantially all assets of the Seller, the purchaser thereof, shall assume the obligations of the Seller on an unsecured basis.
2
CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***], HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) IS THE TYPE THAT THE REGISTRANT TREATS AS PRIVATE OR CONFIDENTIAL.
(b) Notwithstanding subsection (a), no Change of Control Payment shall be due in connection with a Change of Control occurring [***] and consisting of [***].
“Additional Contracts” means all Additional Transferred Assets that constitute contracts, agreements or other written obligations, including, without limitation, the Supply Agreement and the Steris Agreement.
“Additional Contract Counterparty” means any counterparty to an Additional Contract.
“Additional Transferred Assets” means the assets described on Exhibit A to the Amendment Agreement.
“Amendment Agreement” means that certain Omnibus Amendment Agreement, dated as of the Amendment Date, by and among Company, Product Sub, Purchaser and Purchaser Agent.
“Amendment Date” means September 4, 2025.
“Amendment Date Bill of Sale” means that certain Bill of Sale, dated as of the Amendment Date, executed by the Company and the Product Sub, in the form attached to the Amendment Agreement.
“Confirmatory Bills of Sale” has the meaning set forth in Section 2.01(e)(iii).
“Permitted Intercompany Agreements” means, with respect to each Additional Transferred Asset, one or more agreements providing for an appropriate grant back license, consent to use, and/or right of reference thereto as may be necessary or desirable in connection with the Company’s business.
“Permitted Contribution Liens” means Permitted Liens (as defined in the Equity Pledge Agreement), the Permitted Platform License, the Permitted Intercompany Agreements, and any other Liens created in favor of the Purchaser or the Purchaser Agent under the Transaction Documents and Liens consisting of rights of any third party licensee of Intellectual Property Rights.
3
CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***], HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) IS THE TYPE THAT THE REGISTRANT TREATS AS PRIVATE OR CONFIDENTIAL.
(e) (i) (A) On the Amendment Date, the Company shall Contribute to Product Sub, and Product Sub shall purchase, acquire and accept from the Company, without recourse except to the extent provided in this Agreement, all of the Company’s rights, title and interest in and to, and obligations under the Additional Transferred Assets listed on Part I of Exhibit A to the Amendment Agreement, free and clear of any and all Liens, except Permitted Contribution Liens and (B) within [***] Business Days of the Amendment Date, the Company shall Contribute to Product Sub, without recourse except to the extent provided in this Agreement, all of the Company’s rights, title and interest in and to, and obligations under the Additional Transferred Assets listed on Part II of Exhibit A to the Amendment Agreement, free and clear of any and all Liens, except Permitted Contribution Liens. The Company and Product Sub intend and agree that the sale, assignment, transfer, contribution and conveyance of the Additional Transferred Assets under this Agreement shall be, and each is, a true, complete, absolute and irrevocable assignment and sale and a true, complete, absolute and irrevocable contribution by the Company to Product Sub of the Additional Transferred Assets and that such assignments and sales and such contributions shall provide Product Sub with all of the Company’s rights, title and interest in and to the Additional Transferred Assets. The Product Sub and the Purchaser shall each have a right to specific performance of this Section 2.01(e)(i), and the Company acknowledges that the failure of the Company to perform the obligations in this Section 2.01(e)(i) will not give rise to an adequate remedy at law.
(ii) In full consideration of the Contribution of (or the agreement to so Contribute) the Additional Transferred Assets to Product Sub, Product Sub shall: (i) pay (or cause to be paid) the Amendment Payment (less the Purchaser Amendment Expenses) within [***] Business Days following receipt, in each case by transferring (or causing to be transferred) the applicable amount to the account specified by the Company in writing and accepting and reflecting in its financial accounts a capital contribution from the Company in an amount equal to any additional value of the Additional Transferred Assets in excess of the Investment Amount as of such date, and (ii) assume all of Company’s liabilities and obligations under the Additional Transferred Assets from and after the date each Additional Transferred Asset is contributed by Company to Product Sub, provided, however, [***]. The Company, concurrently with the execution and delivery of the Amendment Agreement, hereby contributes to Product Sub all of the value of the Additional Transferred Assets in excess of the Amendment Payment, as a contribution to the capital of Product Sub. Product Sub acknowledges receipt of such capital contribution and its entry in the financial records of Product Sub as a capital contribution.
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(iii) The Contribution of the Additional Transferred Assets listed on Part II of Exhibit A to the Amendment Agreement shall be subject to additional, confirmatory bills of sale (the “Confirmatory Bills of Sale”) to be delivered as soon as practicable following the Amendment Date.
(f) Product Sub hereby agrees to execute and deliver to Company such Permitted Intercompany Agreements as Company may reasonably request from time to time from and after the Amendment Date.
(i) The Company shall not, except with Product Sub’s and Purchaser’s consent, enter into, or agree to enter into, any new contract, agreement or legally binding arrangement which would reasonably be expected to impair or have an adverse effect on the Additional Contracts. The Company shall promptly (and in any case within [***]Business Days) deliver to Product Sub and Purchaser copies of all fully-executed or definitive writings related to the matters set forth in the preceding sentence.
(ii) [***].
(iii) [***].
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Section 6.08 Limited Waiver. [***].
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For purposes hereof, the term “Purchaser Amendment Expenses” shall mean the amount of the Purchaser’s actual, documented, out-of-pocket fees and expenses incurred in connection with the Purchaser’s confirmatory due diligence and legal documentation associated with the negotiation and execution of this Agreement, provided that in no event shall the Purchaser Amendment Expenses exceed $100,000.
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IN WITNESS WHEREOF, this Agreement has been duly executed and delivered by the undersigned as of the date first written above.
SELLER:
COMPANY: |
CLEARSIDE SPV LLC By: /s/ George Lasezkay
CLEARSIDE BIOMEDICAL, INC.
By: /s/ George Lasezkay |
PURCHASER:
PURCHASER AGENT: |
HEALTHCARE ROYALTY PARTNERS IV, L.P.
By: HealthCare Royalty GP IV, LLC, its general partner
By: /s/ Clarke Futch Name: Clarke Futch
HCR CLEARSIDE SPV, LLC.
By: /s/ Clarke Futch Name: Clarke Futch
|
[Signature Page – AMENDMENT AGREEMENT]
CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***], HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) IS THE TYPE THAT THE REGISTRANT TREATS AS PRIVATE OR CONFIDENTIAL.
Exhibit A
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CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***], HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) IS THE TYPE THAT THE REGISTRANT TREATS AS PRIVATE OR CONFIDENTIAL.
Exhibit B
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Exhibit 31.1
CERTIFICATION OF PRINCIPAL EXECUTIVE OFFICER
PURSUANT TO SECTION 302 OF THE SARBANES-OXLEY ACT OF 2002
I, George Lasezkay, certify that:
Date: November 14, 2025
|
/s/ George Lasezkay, Pharm.D., J.D. |
|
George Lasezkay, Pharm. D., J.D. |
|
President and Chief Executive Officer |
|
(principal executive officer) |
Exhibit 31.2
CERTIFICATION OF PRINCIPAL FINANCIAL OFFICER
PURSUANT TO SECTION 302 OF THE SARBANES-OXLEY ACT OF 2002
I, Charles A. Deignan, certify that:
Date: November 14, 2025
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/s/ Charles A. Deignan |
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Charles A. Deignan |
|
Chief Financial Officer |
|
(principal financial officer) |
Exhibit 32.1
CERTIFICATIONS OF
PRINCIPAL EXECUTIVE OFFICER AND PRINCIPAL FINANCIAL OFFICER
PURSUANT TO 18 U.S.C. SECTION 1350,
AS ADOPTED PURSUANT TO
SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002
Pursuant to the requirement set forth in Rule 13a-14(b) of the Securities Exchange Act of 1934, as amended, (the “Exchange Act”) and Section 1350 of Chapter 63 of Title 18 of the United States Code (18 U.S.C. §1350), George Lasezkay, President and Chief Executive Officer of Clearside Biomedical, Inc. (the “Company”), and Charles A. Deignan, Chief Financial Officer of the Company, each hereby certifies that, to the best of his knowledge:
IN WITNESS WHEREOF, the undersigned have set their hands hereto as of the 14th day of November, 2025.
/s/ George Lasezkay, Pharm. D., J.D. |
|
/s/ Charles. A. Deignan |
George Lasezkay, Pharm. D., J.D. |
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Charles A. Deignan |
President and Chief Executive Officer |
|
Chief Financial Officer |
* This certification accompanies the Form 10-Q to which it relates, is not deemed filed with the Securities and Exchange Commission and is not to be incorporated by reference into any filing of the Company under the Securities Act of 1933, as amended, or the Exchange Act (whether made before or after the date of the Form 10-Q), irrespective of any general incorporation language contained in such filing.