[10-Q] EyePoint, Inc. Quarterly Earnings Report
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM
For the quarterly period ended
OR
☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the transition period from _______ to _______
COMMISSION FILE NUMBER
(Exact name of registrant as specified in its charter)
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(Registrant’s telephone number, including area code)
(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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Name of each exchange on which registered |
Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.
Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§ 232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files).
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company” and “emerging growth company” in Rule 12b-2 of the Exchange Act.
Large accelerated filer |
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Emerging growth company |
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
There were
EYEPOINT, INC. AND SUBSIDIARIES
INDEX TO FORM 10-Q
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PART I. FINANCIAL INFORMATION |
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Item 1. |
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Unaudited Financial Statements |
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Condensed Consolidated Balance Sheets – March 31, 2026 and December 31, 2025 |
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Condensed Consolidated Statements of Operations and Comprehensive Loss – Three Months Ended March 31, 2026 and 2025 |
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Condensed Consolidated Statements of Stockholders’ Equity – Three Months Ended March 31, 2026 and 2025 |
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Condensed Consolidated Statements of Cash Flows – Three Months Ended March 31, 2026 and 2025 |
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Notes to Condensed Consolidated Financial Statements |
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7 |
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Item 2. |
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Management’s Discussion and Analysis of Financial Condition and Results of Operations |
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18 |
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Item 3. |
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Quantitative and Qualitative Disclosures about Market Risk |
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24 |
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Item 4. |
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Controls and Procedures |
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24 |
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PART II: OTHER INFORMATION |
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Item 1. |
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Legal Proceedings |
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25 |
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Item 1A. |
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Risk Factors |
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25 |
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Item 2. |
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Unregistered Sales of Equity Securities and Use of Proceeds |
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26 |
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Item 3. |
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Defaults Upon Senior Securities |
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26 |
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Item 4. |
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Mine Safety Disclosures |
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26 |
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Item 5. |
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Other Information |
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26 |
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Item 6. |
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Exhibits |
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28 |
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Signatures |
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30 |
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2
PART I. FINANCIAL INFORMATION
Item 1. Unaudited Financial Statements
EYEPOINT, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED BALANCE SHEETS
(Unaudited)
(In thousands except share data)
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March 31, |
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December 31, |
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2026 |
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2025 |
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Assets |
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Current assets: |
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Cash and cash equivalents |
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$ |
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$ |
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Marketable securities |
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Accounts and other receivables, net |
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Prepaid expenses and other current assets |
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Inventory |
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Total current assets |
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Property and equipment, net |
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Operating lease right-of-use assets |
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Restricted cash |
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Other assets |
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Total assets |
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$ |
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$ |
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Liabilities and stockholders' equity |
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Current liabilities: |
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Accounts payable |
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$ |
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$ |
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Accrued expenses |
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Other current liabilities |
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Total current liabilities |
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Operating lease liabilities – noncurrent |
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Other noncurrent liabilities |
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Total liabilities |
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Contingencies (Note 12) |
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Stockholders' equity: |
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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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( |
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( |
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Accumulated other comprehensive income (loss) |
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Total stockholders' equity |
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Total liabilities and stockholders' equity |
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$ |
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$ |
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See notes to condensed consolidated financial statements.
3
EYEPOINT, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(Unaudited)
(In thousands except per share data)
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Three Months Ended |
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March 31, |
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2026 |
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2025 |
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Revenues: |
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Product sales, net |
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$ |
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$ |
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License and collaboration agreements |
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Royalty income |
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Total revenues |
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Operating expenses: |
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Cost of sales |
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Research and development |
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Sales and marketing |
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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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( |
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( |
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Other (expense) income: |
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Interest and other income, net |
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Total other income, net |
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Provision for income taxes |
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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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Net loss per share: |
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Basic and diluted |
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$ |
( |
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$ |
( |
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Weighted average common shares outstanding: |
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Basic and diluted |
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Net loss |
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$ |
( |
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$ |
( |
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Other comprehensive gain (loss): |
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Unrealized gain (loss) on available-for-sale |
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( |
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( |
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Comprehensive loss |
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$ |
( |
) |
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$ |
( |
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See notes to condensed consolidated financial statements.
4
EYEPOINT, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS' EQUITY
(Unaudited)
(In thousands except share data)
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Common Stock |
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Additional |
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Accumulated |
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Total |
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Number of |
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Par Value |
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Paid-In |
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Accumulated |
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Comprehensive |
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Stockholders’ |
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Balance at December 31, 2024 |
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$ |
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$ |
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$ |
( |
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$ |
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$ |
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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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Unrealized gain (loss) on available-for-sale securities |
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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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Employee stock purchase plan |
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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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Stock units granted, net of units withheld for tax |
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( |
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— |
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— |
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( |
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Stock-based compensation |
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— |
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— |
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— |
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— |
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Balance at March 31, 2025 |
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$ |
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$ |
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$ |
( |
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$ |
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$ |
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Balance at December 31, 2025 |
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$ |
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$ |
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$ |
( |
) |
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$ |
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$ |
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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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Unrealized gain (loss) on available-for-sale securities |
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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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Employee stock purchase plan |
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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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Stock units granted, net of units withheld for tax |
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— |
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( |
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— |
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— |
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( |
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Stock-based compensation |
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— |
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— |
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— |
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— |
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Balance at March 31, 2026 |
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$ |
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$ |
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$ |
( |
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$ |
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$ |
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See notes to condensed consolidated financial statements.
5
EYEPOINT, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(Unaudited)
(In thousands)
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Three Months Ended |
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March 31 |
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2026 |
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2025 |
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Cash flows from operating activities: |
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Net loss |
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$ |
( |
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$ |
( |
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Adjustments to reconcile net loss to cash flows used in |
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Depreciation of property and equipment |
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Amortization of debt discount and premium and discount on |
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( |
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( |
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Stock-based compensation |
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Changes in operating assets and liabilities: |
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Accounts receivable and other current assets |
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( |
) |
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Other assets |
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( |
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( |
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Inventory |
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Accounts payable and accrued expenses |
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Right-of-use assets and operating lease liabilities |
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( |
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Deferred revenue |
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( |
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Other noncurrent liabilities |
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( |
) |
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— |
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Net cash (used in) provided by operating activities |
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( |
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( |
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Cash flows from investing activities: |
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Purchases of marketable securities |
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( |
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( |
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Sales and maturities of marketable securities |
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Purchases of property and equipment |
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( |
) |
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( |
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Net cash (used in) provided by investing activities |
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Cash flows from financing activities: |
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Payment of equity issue costs |
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( |
) |
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( |
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Net settlement of stock units to satisfy statutory tax withholding |
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( |
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( |
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Proceeds from exercise of stock options and employee stock purchase plan |
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Principal payments on finance lease obligations |
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( |
) |
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( |
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Net cash (used in) provided by financing activities |
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( |
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( |
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Net (decrease) increase in cash, cash equivalents and restricted cash |
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( |
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( |
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Cash, cash equivalents and restricted cash at beginning of period |
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Cash, cash equivalents and restricted cash at end of period |
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$ |
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$ |
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Reconciliation of cash, cash equivalents and restricted cash to the consolidated balance sheets: |
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Cash and cash equivalents |
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$ |
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$ |
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Restricted cash |
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Total cash, cash equivalents and restricted cash at end of period |
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$ |
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$ |
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Supplemental disclosure of non-cash investing and financing activities: |
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Lease liability arising from obtaining right-of-use assets |
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$ |
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$ |
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Property and equipment additions in accounts payable and accrued expenses |
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$ |
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$ |
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Stock issuance costs in accounts payable and accrued expenses |
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$ |
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$ |
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See notes to condensed consolidated financial statements.
6
EYEPOINT, INC. AND SUBSIDIARIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(Unaudited)
The accompanying condensed consolidated financial statements of EyePoint, Inc., a Delaware corporation (together with its subsidiaries, the Company), as of March 31, 2026 and for the three months ended March 31, 2026 and 2025 are unaudited. Certain information in the footnote disclosures of these financial statements has been condensed or omitted in accordance with the rules and regulations of the Securities and Exchange Commission. These financial statements should be read in conjunction with the Company’s audited consolidated financial statements and footnotes included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2025. In the opinion of management, these statements have been prepared on the same basis as the audited consolidated financial statements as of and for the year ended December 31, 2025, and include all adjustments, consisting only of normal recurring adjustments, that are necessary for the fair presentation of the Company’s financial position, results of operations, and cash flows for the periods indicated. The preparation of financial statements in accordance with United States (U.S.) generally accepted accounting principles requires management to make assumptions and estimates that affect, among other things, (i) reported amounts of assets and liabilities; (ii) disclosure of contingent assets and liabilities at the date of the condensed consolidated financial statements; and (iii) reported amounts of revenues and expenses during the reporting period. The results of operations for the three months ended March 31, 2026 are not necessarily indicative of the results that may be expected for the entire 2026 fiscal year or any future period.
The Company is committed to developing and commercializing innovative therapeutics to help improve the lives of patients with serious retinal diseases. The Company's pipeline leverages its proprietary bioerodible Durasert E™ technology (Durasert E™) for sustained intraocular drug delivery. The Company’s lead product candidate, DURAVYU™1 (a/k/a EYP-1901), is an investigational sustained delivery treatment for vascular endothelial growth factor (VEGF) mediated retinal diseases combining vorolanib, a selective and patent-protected tyrosine kinase inhibitor (TKI) with Durasert E™. DURAVYU is currently being evaluated in Phase 3 pivotal trials (LUGANO and LUCIA) for wet age-related macular degeneration (wet AMD) with data readout beginning in mid-2026. Pivotal Phase 3 clinical trials (COMO and CAPRI) in diabetic macular edema (DME) dosed first patients in February 2026 with enrollment completion anticipated in the third quarter of 2026. EyePoint is headquartered in Watertown, Massachusetts with a commercial manufacturing facility in Northbridge, Massachusetts.
The Company plans to identify and advance additional product candidates through clinical development for its pipeline. This may be accomplished through internal discovery efforts, research collaborations and/or in-licensing arrangements and potential acquisitions of additional products, product candidates or technologies.
Liquidity
The Company had cash, cash equivalents and investments in marketable securities of $
1. DURAVYU™ has been conditionally accepted by the FDA as the proprietary name for EYP-1901. DURAVYU is an investigational product candidate; it has not been approved by the FDA. FDA approval and the timeline for potential approval is uncertain.
7
The Company’s significant accounting policies are disclosed in the audited consolidated financial statements for the year ended December 31, 2025, and notes thereto, which are included in the Company’s Annual Report on Form 10-K that was filed with the Securities and Exchange Commission, or the SEC, on March 5, 2026, or the 2025 Form 10-K. Since the date of those financial statements, there have been no material changes to the Company's significant accounting policies.
Recent Accounting Pronouncements
In November 2024, the FASB issued ASU 2024-03—Income Statement —Reporting Comprehensive Income —Expense Disaggregation Disclosures (Subtopic 220-40): Disaggregation of Income Statement Expenses. The amendments in ASU 2024-03 address investor requests for more detailed expense information and require additional disaggregated disclosures in the notes to financial statements for certain categories of expenses that are included on the face of the income statement. This guidance is effective for fiscal years beginning after December 15, 2026, and interim periods within fiscal years beginning after December 15, 2027, with early adoption permitted. The Company is currently evaluating the impact of adopting this ASU on its consolidated financial statements and disclosures.
In December 2025, the FASB issued ASU 2025-11, Interim Reporting (Topic 270): Improvements to Interim Disclosure Requirements, which clarifies disclosure requirements for interim financial statements. The ASU is effective for interim reporting periods beginning after December 15, 2027, with early adoption permitted. The Company is currently evaluating the impact of adopting this ASU on its consolidated financial statements and disclosures
In December 2025, the FASB issued ASU No. 2025-12, Codification Improvements, which includes targeted amendments to clarify, correct, and improve various aspects of the FASB Accounting Standards Codification. The ASU is effective for annual periods beginning after December 15, 2026, and interim periods within those annual reporting periods, with early adoption permitted. The Company is currently evaluating the impact of adopting this ASU on its consolidated financial statements and disclosures
License and Collaboration Agreements and Royalty Income
ANI Product Rights Agreement (PRA) and Commercial Supply Agreement
On
Additionally, pursuant to the PRA, the Company transferred and assigned to ANI certain assets and certain contracts with third parties related to YUTIQ®, including the new drug application for YUTIQ® (collectively, the Asset Transfer). Pursuant to the PRA, ANI paid the Company a $
The Company and ANI also entered into a commercial supply agreement (CSA), pursuant to which, during the term of the PRA, the Company agreed to manufacture and exclusively supply to ANI agreed-upon quantities of YUTIQ® necessary for ANI to commercialize YUTIQ® in the United States at certain cost plus amounts, subject to adjustments and potential extensions and terminations set forth in the CSA. The CSA with ANI automatically terminated on May 31, 2025.
Revenue from sales of product supply to ANI under the CSA was $
8
SWK Royalty Purchase Agreement
Pursuant to a royalty purchase agreement (RPA) with SWK Funding LLC (SWK), the Company sold its right to receive royalty payments on future sales of products subject to a licensing and development agreement, as amended, with ANI (the Amended ANI Agreement) for an upfront cash payment of $
On March 18, 2025, ANI announced that it completed the buyout of its
The Company recognized $
Ocumension Therapeutics
The Company entered into an Exclusive License Agreement on November 2, 2018, as amended by a Memorandum of Understanding dated March 1, 2019, a Memorandum of Understanding dated August 18, 2020, a Supply and Quality Agreement on February 19, 2019 and a Memorandum of Understanding on August 26, 2024. Pursuant to the license agreement and Memorandum of Understanding signed with the Company, Ocumension has:
During the three months ended March 31, 2026 and 2025, the Company recognized $
Prepaid expenses and other current assets consisted of the following (in thousands):
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March 31, |
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December 31, |
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Prepaid expenses |
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$ |
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$ |
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Prepaid clinical |
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Other |
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Total prepaid expenses and other current assets |
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$ |
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$ |
|
||
As of March 31, 2026 and December 31, 2025 the Company also had $
9
Inventory consisted of the following (in thousands):
|
|
March 31, |
|
|
December 31, |
|
||
Raw materials |
|
$ |
|
|
$ |
|
||
Work in process |
|
|
|
|
|
|
||
Total inventory |
|
$ |
|
|
$ |
|
||
As of March 31, 2026 and December 31, 2025,
Accrued expenses consisted of the following (in thousands):
|
|
March 31, |
|
|
December 31, |
|
||
|
|
2026 |
|
|
2025 |
|
||
Personnel costs |
|
$ |
|
|
$ |
|
||
Clinical trial costs |
|
|
|
|
|
|
||
Professional fees, contingencies and legal fees |
|
|
|
|
|
|
||
Sales chargebacks, rebates and other revenue reserves |
|
|
|
|
|
|
||
Other |
|
|
|
|
|
|
||
Total accrued expenses |
|
$ |
|
|
$ |
|
||
On February 13, 2026, the Company amended the lease for its headquarters in Watertown, Massachusetts. Under the amendment, the Company leased an additional
On March 31, 2025, the Company amended the lease for its headquarters in Watertown, Massachusetts to extend the term to
On January 23, 2023, the Company entered into a lease agreement (the Northbridge Lease) for its new standalone commercial manufacturing facility, including office and lab space located at 600 Commerce Drive, Northbridge, Massachusetts. The new
Since the Company elected to account for each lease component and its associated non-lease components as a single combined component, all contract consideration was allocated to the respective lease components. The expected lease terms include non-cancellable lease periods. Renewal option periods have not been included in the determination of the lease terms as they are not deemed reasonably certain of exercise. Variable lease payments, such as common area maintenance, real estate taxes, and property insurance are not included in the determination of the lease’s ROU asset or lease liability.
10
As of March 31, 2026 the weighted average remaining term of the Company’s operating leases was 1
Supplemental balance sheet information related to operating leases are as follows (in thousands):
|
|
March 31, |
|
|
December 31, |
|
||
|
|
2026 |
|
|
2025 |
|
||
Other current liabilities – operating lease current portion |
|
$ |
|
|
$ |
|
||
Operating lease liabilities – noncurrent portion |
|
|
|
|
|
|
||
Total operating lease liabilities |
|
$ |
|
|
$ |
|
||
The elements of lease expense were as follows (in thousands):
|
|
Three Months Ended |
|
|||||
|
|
2026 |
|
|
2025 |
|
||
Lease expense included in: |
|
|
|
|
|
|
||
Research and development |
|
$ |
|
|
$ |
|
||
General and administrative |
|
|
|
|
|
|
||
Variable lease costs |
|
|
|
|
|
|
||
Total lease expense |
|
$ |
|
|
$ |
|
||
Cash paid for amounts included in the measurement of operating lease liabilities was $
The Company’s total future minimum lease payments under non-cancellable leases at March 31, 2026 were as follows (in thousands):
|
|
Operating Leases |
|
|
2026 |
|
|
|
|
2027 |
|
|
|
|
2028 |
|
|
|
|
2029 |
|
|
|
|
Thereafter |
|
|
|
|
Total lease payments |
|
$ |
|
|
Less imputed interest |
|
|
( |
) |
Total |
|
$ |
|
|
ATM Facility
In August 2020, the Company entered into an at-the-market facility (the ATM Facility) with Cantor Fitzgerald & Co (Cantor). Pursuant to the ATM Facility, the Company may, at its option, offer and sell shares of its common stock from time to time, through or to Cantor, acting as sales agent. The Company will pay Cantor a commission of
During the three months ended March 31, 2026 and 2025, we did
During April and May 2026, the Company sold
11
Warrants to Purchase Common Shares
The Company issued
The Company issued
As of March 31, 2026 and 2025,
Equity Incentive Plan
The 2023 Long-Term Incentive Plan (the “2023 Plan”), approved by the Company’s stockholders on
Starting March 2022, the Company granted non-statutory stock options to new employees as inducement awards to enter into employment with the Company. The grants were approved by the Compensation Committee of the Board of Directors and awarded in accordance with Nasdaq Listing Rule 5635(c)(4). Although not awarded under any equity incentive plans, the grants are subject to and governed by the terms and conditions of the applicable plan in effect at the time of the grant.
Stock Options
The following table provides a reconciliation of stock option activity under the Company’s equity incentive plan and for inducement awards for the three months ended March 31, 2026:
|
|
Number of |
|
|
Weighted |
|
|
Weighted |
|
|
Aggregate |
|
||||
|
|
|
|
|
|
|
|
(in years) |
|
|
(in thousands) |
|
||||
Outstanding at December 31, 2025 |
|
|
|
|
$ |
|
|
|
|
|
|
|
||||
Granted |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Exercised |
|
|
( |
) |
|
|
|
|
|
|
|
|
|
|||
Forfeited |
|
|
( |
) |
|
|
|
|
|
|
|
|
|
|||
Expired |
|
|
( |
) |
|
|
|
|
|
|
|
|
|
|||
Outstanding at March 31, 2026 |
|
|
|
|
$ |
|
|
|
|
|
$ |
|
||||
Exercisable at March 31, 2026 |
|
|
|
|
$ |
|
|
|
|
|
$ |
|
||||
The Company's stock options generally vest over
12
The Company recognizes stock-based compensation expense over the requisite service period based on the grant date fair value of the award. The Company has elected to use the Black-Scholes option pricing model to determine the fair value of awards granted. The determination of the fair value of stock-based awards utilizing the Black-Scholes model is affected by the share price and a number of assumptions, including expected volatility, expected life, risk-free interest rate and expected dividends. The Company determined the expected volatility by using available historical price information. The expected life of the awards is estimated based on the simplified method. The risk-free interest rate assumption is based on observed interest rates appropriate for the terms of the awards. The dividend yield assumption is based on history and expectation of paying no dividends. Forfeitures have not been material in the periods presented.
The fair value of the share-based awards was measured with the following range of assumptions for the three months ended March 31, 2026:
|
|
Three Months Ended |
|
|
March 31, 2026 |
Option life (in years) |
|
|
Stock volatility |
|
|
Risk-free interest rate |
|
|
Expected dividends |
|
The following table summarizes information about employee, non-executive director and external consultant stock options for the three months ended March 31, 2026 (in thousands except per share amount):
|
|
Three Months Ended |
|
|
|
|
March 31, 2026 |
|
|
Weighted average grant date fair value per share |
|
$ |
|
|
Total cash received from exercise of stock options |
|
|
|
|
Total intrinsic value of stock options exercised |
|
|
|
|
Performance Options
During the first quarter of 2026, the Company’s board of directors approved the issuance of stock options to purchase an aggregate of
For the three months ended March 31, 2026, the Company recognized
Time-Vested Restricted Stock Units
Time-vested restricted stock units (RSUs) issued to date under the 2016 Plan and the 2023 Plan generally vest on a ratable annual basis over
The following table provides a reconciliation of RSU activity under the 2016 Plan and the 2023 Plan for the three months ended March 31, 2026:
|
|
Number of Restricted Stock Units |
|
|
Weighted Average Grant Date Fair Value |
|
||
Nonvested at December 31, 2025 |
|
|
|
|
$ |
|
||
Granted |
|
|
|
|
|
|
||
Vested |
|
|
( |
) |
|
|
|
|
Forfeited |
|
|
( |
) |
|
|
|
|
Nonvested at March 31, 2026 |
|
|
|
|
$ |
|
||
13
At March 31, 2026, the weighted average remaining vesting term of the RSUs was
Employee Stock Purchase Plan
The Company’s Employee Stock Purchase Plan (the ESPP) allows qualified participants to purchase the Company’s common stock twice a year at
The Company estimated the fair value of the option component of the ESPP shares at the date of grant using a Black-Scholes valuation model. During the three months ended March 31, 2026, and 2025 the compensation expense from ESPP shares was $
Stock-Based Compensation Expense
The Company’s condensed consolidated statements of operations and comprehensive loss included total compensation expense from stock-based payment awards as follows (in thousands):
|
|
Three Months Ended |
|
|||||
|
|
2026 |
|
|
2025 |
|
||
Compensation expense included in: |
|
|
|
|
|
|
||
Research and development |
|
$ |
|
|
$ |
|
||
General and administrative |
|
|
|
|
|
|
||
Total |
|
$ |
|
|
$ |
|
||
At March 31, 2026, there was approximately $
The following tables summarize the Company’s assets by significant categories carried at fair value measured on a recurring basis by valuation hierarchy (in thousands):
|
|
March 31, 2026 |
|
|||||||||||||||||||||
|
|
Carrying |
|
|
Gross |
|
|
Gross |
|
|
Fair Value |
|
|
Cash |
|
|
Marketable Securities |
|
||||||
Level 1: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||
Money market funds |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||||
Subtotal |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||||
Level 2: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||
Commercial paper |
|
$ |
|
|
$ |
|
|
$ |
( |
) |
|
$ |
|
|
$ |
|
|
$ |
|
|||||
U.S. Treasury securities |
|
|
|
|
|
|
|
|
( |
) |
|
|
|
|
|
|
|
|
|
|||||
U.S. Agency securities |
|
|
|
|
|
|
|
|
( |
) |
|
|
|
|
|
|
|
|
|
|||||
Subtotal |
|
$ |
|
|
$ |
|
|
$ |
( |
) |
|
$ |
|
|
$ |
|
|
$ |
|
|||||
Total |
|
$ |
|
|
$ |
|
|
$ |
( |
) |
|
$ |
|
|
$ |
|
|
$ |
|
|||||
14
|
|
December 31, 2025 |
|
|||||||||||||||||||||
|
|
Carrying |
|
|
Gross |
|
|
Gross |
|
|
Fair Value |
|
|
Cash |
|
|
Marketable Securities |
|
||||||
Level 1: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||
Money market funds |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||||
Subtotal |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||||
Level 2: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||
Commercial paper |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||||
U.S. Treasury securities |
|
|
|
|
|
|
|
|
( |
) |
|
|
|
|
|
|
|
|
|
|||||
U.S. Agency securities |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||
Subtotal |
|
$ |
|
|
$ |
|
|
$ |
( |
) |
|
$ |
|
|
$ |
|
|
$ |
|
|||||
Total |
|
$ |
|
|
$ |
|
|
$ |
( |
) |
|
$ |
|
|
$ |
|
|
$ |
|
|||||
At March 31, 2026, a total of $
The Company’s cash equivalents and marketable securities are classified within Level 1 or Level 2 on the basis of valuations using quoted market prices or alternative pricing sources and models utilizing market observable inputs, respectively. The marketable securities have been valued on the basis of valuations provided by third-party pricing services, as derived from such services’ pricing models. Inputs to the models may include, but are not limited to, reported trades, executable bid and ask prices, broker/dealer quotations, prices, or yields of securities with similar characteristics, benchmark curves, or information pertaining to the issuer, as well as industry and economic events. The pricing services may use a matrix approach, which considers information regarding securities with similar characteristics to determine the valuation for a security, and have been classified as Level 2.
The carrying amounts of accounts receivable, accounts payable, and accrued expenses approximate fair value because of their short-term maturity.
Business Segment
The Company operates in
15
Significant segment expenses are as follows (in thousands):
|
Three Months Ended |
|
||||||
|
|
March 31, |
|
|||||
|
|
2026 |
|
|
2025 |
|
||
|
|
|
|
|
|
|
||
Total revenues |
|
$ |
|
|
$ |
|
||
DURAVYU direct research and development expense |
|
|
( |
) |
|
|
( |
) |
Other direct research and development expense |
|
|
( |
) |
|
|
( |
) |
Personnel expense (including stock-based compensation) |
|
|
( |
) |
|
|
( |
) |
Facilities expense |
|
|
( |
) |
|
|
( |
) |
Depreciation and amortization |
|
|
( |
) |
|
|
( |
) |
Intellectual property expense |
|
|
( |
) |
|
|
( |
) |
Legal, corporate and professional expenses |
|
|
( |
) |
|
|
( |
) |
Interest and other income, net |
|
|
|
|
|
|
||
Other segment expenses* |
|
|
( |
) |
|
|
( |
) |
Net loss |
|
|
( |
) |
|
|
( |
) |
*
Legal Proceedings
The Company is subject to various routine legal proceedings and claims incidental to its business, which management believes will not have a material effect on the Company’s financial position, results of operations or cash flows.
U.S. Department of Justice Subpoena
As previously reported, in August 2022, the Company received a subpoena from the U.S. Attorney’s Office for the District of Massachusetts (DOJ), seeking production of documents related to sales, marketing, and promotional practices, including as pertain to DEXYCU®, which the Company commercialized from 2019 to 2023.
The Company has been cooperating fully with the government in connection with this matter, which stems from a sealed qui tam complaint filed in the U.S. District Court for the District of Massachusetts. The DOJ investigation relates to the False Claims Act and the Anti-Kickback Statute, and has focused on certain of the Company’s sales, marketing and promotional practices, including sampling practices, as pertain to DEXYCU during the period for which the Company commercialized this product.
As previously disclosed, the Company has been in discussions with the DOJ regarding a possible negotiated resolution. In the first quarter of 2026, the Company reached an agreement in principle with the DOJ to settle these matters for a payment of approximately $
On February 26, 2026, the Company reached an agreement in principle with HHS to resolve matters related to the DOJ investigation on terms to include the Company entering into a corporate integrity agreement and HHS agreeing not to seek the Company’s exclusion from participation in Medicare, Medicaid, or other federal health care programs.
The agreements in principle are subject to negotiation, completion and execution of appropriate documents resolving these matters, including a settlement agreement and a corporate integrity agreement, which are expected to be finalized in or around the second quarter of 2026. There is no guarantee that the Company will be able to reach final agreement with DOJ or HHS. If the Company is not able to conclude a final resolution with the U.S. government, the DOJ may elect to proceed against the Company and
16
seek damages in excess of the agreed in principle settlement amount, which potential liability cannot be reasonably estimated. Should a negotiated resolution of these matters not be achieved, the Company intends to defend itself vigorously.
Basic net loss per share is computed by dividing the net loss by the weighted average number of common shares outstanding during the period. For periods in which the Company reports net income, diluted net income per share is determined by adding to the basic weighted average number of common shares outstanding the total number of dilutive common equivalent shares using the treasury stock method, unless the effect is anti-dilutive.
Common stock equivalents excluded from the calculation of diluted earnings per share because the effect would have been anti-dilutive were as follows:
|
|
As of March 31, |
|
|||||
|
|
2026 |
|
|
2025 |
|
||
Stock options |
|
|
|
|
|
|
||
ESPP |
|
|
|
|
|
|
||
Restricted stock units |
|
|
|
|
|
|
||
Total |
|
|
|
|
|
|
||
Nancy S. Lurker, the former Chief Executive Officer and Executive Vice Chair of the Company and current Vice Chair of the Board is a member of the board of directors of Altasciences, the parent company of Calvert Laboratories, Inc. (Calvert Labs), an entity with which the Company conducts business. The Company recorded $
17
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations
Note Regarding Forward-Looking Statements
Various statements made in this Quarterly Report on Form 10-Q are forward-looking and involve risks and uncertainties. All statements that address activities, events or developments that we intend, expect or believe may occur in the future are 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. Such statements give our current expectations or forecasts of future events and are not statements of historical or current facts. These statements include, among others, statements about:
Forward-looking statements also include statements other than statements of current or historical fact, including, without limitation, all statements related to any expectations of revenues, expenses, cash flows, earnings or losses from operations, cash required to maintain current and planned operations, capital or other financial items; any statements of the plans, strategies and objectives of management for future operations; any plans or expectations with respect to product research, development and commercialization, including regulatory approvals; any other statements of expectations, plans, intentions or beliefs; and any statements of assumptions underlying any of the foregoing. We often, although not always, identify forward-looking statements by using words or phrases such as “likely”, “expect”, “intend”, “anticipate”, “believe”, “estimate”, “plan”, “project”, “forecast”, and “outlook”.
The following are some of the factors that could cause actual results to differ materially from the anticipated results or other expectations expressed, anticipated, or implied in our forward-looking statements:
18
We cannot guarantee that the results and other expectations expressed, anticipated or implied in any forward-looking statement will be realized. The risks set forth under Item 1A of our Annual Report on Form 10-K for the fiscal year ended December 31, 2025, as supplemented by the risks set forth under Item 1A of this Quarterly Report on Form 10-Q, describe major risks to our business, and you should read and interpret any forward-looking statements together with these risks. A variety of factors, including these risks, could cause our actual results and other expectations to differ materially from the anticipated results or other expectations expressed, anticipated or implied in our forward-looking statements. Should known or unknown risks materialize, or should underlying assumptions prove inaccurate, actual results could differ materially from past results and those anticipated, estimated, or projected in the forward-looking statements. You should bear this in mind as you consider any forward-looking statements.
Our forward-looking statements speak only as of the dates on which they are made. We do not undertake any obligation to publicly update or revise our forward-looking statements even if experience or future changes makes it clear that any projected results expressed or implied in such statements will not be realized.
EYEPOINT®, DEXYCU®, Durasert®, DELIVERING INNOVATION TO THE EYE® and WITH AN EYE ON PATIENTS® are our trademarks. ILUVIEN® is ANI’s trademark The reports we file or furnish with the SEC, including this Quarterly Report on Form 10-Q, also contain trademarks, trade names, and service marks of other companies, which are the property of their respective owners.
Our Business
Overview
We are a clinical-stage biopharmaceutical company committed to developing and commercializing innovative therapeutics to improve the lives of patients with serious retinal diseases. Our pipeline leverages proprietary bioerodible Durasert E™ technology (Durasert E™) for sustained intraocular drug delivery. Our lead product candidate, DURAVYU™ (a/k/a EYP-1901), is an investigational sustained delivery treatment for vascular endothelial growth factor (VEGF) mediated retinal diseases combining
19
vorolanib, a selective and patent-protected tyrosine kinase inhibitor (TKI) with Durasert E™. EyePoint is headquartered in Watertown, Massachusetts with a commercial manufacturing facility in Northbridge, Massachusetts.
DURAVYU brings a potential new multi-mechanism of action paradigm for the treatment of retinal diseases as vorolanib, the active drug in DURAVYU, acts through intracellular inhibition of all VEGF receptors, platelet-derived growth factor (PDGF) receptor, and pro-inflammatory interleukin 6 (IL-6)/JAK1 signaling. Vorolanib has also demonstrated neuroprotection in an in-vivo model of retinal detachment.
DURAVYU is being evaluated in Phase 3 clinical trials for the potential treatment of wet AMD and DME, the two largest retinal disease markets. Enrollment in the pivotal Phase 3 clinical trials for wet AMD is complete with data expected beginning in mid-2026. The first patients were dosed in both DME trials in February 2026 with enrollment completion expected in Q3 2026.
Recent Developments
R&D Highlights
Critical Accounting Policies and Estimates
The preparation of consolidated financial statements in conformity with GAAP requires that we make certain estimates, judgments, and assumptions that affect the reported amounts of assets, liabilities, revenues, and expenses. We base our estimates, judgments, and assumptions on historical experience, anticipated results, and trends, and on various other factors that we believe are reasonable under the circumstances at the time. By their nature, these estimates, judgments, and assumptions are subject to an inherent degree of uncertainty. Actual results may differ from our estimates under different assumptions or conditions. In our Annual Report on Form 10-K for the fiscal year ended December 31, 2025, we set forth our critical accounting policies and estimates, which included revenue recognition and recognition of expense in outsourced clinical trial agreements. See Note 2 of the notes to our unaudited
20
condensed consolidated financial statements contained in this Quarterly Report on Form 10-Q for a description of our accounting policies and estimates.
Results of Operations
Three Months Ended March 31, 2026 Compared to Three Months Ended March 31, 2025:
|
|
Three Months Ended |
|
|
|
|
||||||||||
|
|
March 31, |
|
|
Change |
|
||||||||||
|
|
2026 |
|
|
2025 |
|
|
Amounts |
|
|
% |
|
||||
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
Revenues: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Product sales, net |
|
$ |
467 |
|
|
$ |
715 |
|
|
$ |
(248 |
) |
|
|
-35 |
% |
License and collaboration agreements |
|
|
88 |
|
|
|
11,049 |
|
|
|
(10,961 |
) |
|
|
-99 |
% |
Royalty income |
|
|
141 |
|
|
|
12,689 |
|
|
|
(12,548 |
) |
|
|
-99 |
% |
Total revenues |
|
|
696 |
|
|
|
24,453 |
|
|
|
(23,757 |
) |
|
|
-97 |
% |
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Cost of sales |
|
|
528 |
|
|
|
805 |
|
|
|
(277 |
) |
|
|
-34 |
% |
Research and development |
|
|
72,148 |
|
|
|
58,574 |
|
|
|
13,574 |
|
|
|
23 |
% |
Sales and marketing |
|
|
3 |
|
|
|
35 |
|
|
|
(32 |
) |
|
|
-91 |
% |
General and administrative |
|
|
15,243 |
|
|
|
13,876 |
|
|
|
1,367 |
|
|
|
10 |
% |
Total operating expenses |
|
|
87,922 |
|
|
|
73,290 |
|
|
|
14,632 |
|
|
|
20 |
% |
Loss from operations |
|
|
(87,226 |
) |
|
|
(48,837 |
) |
|
|
(38,389 |
) |
|
|
79 |
% |
Other income (expense): |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Interest and other income, net |
|
|
2,344 |
|
|
|
3,642 |
|
|
|
(1,298 |
) |
|
|
-36 |
% |
Total other income, net |
|
|
2,344 |
|
|
|
3,642 |
|
|
|
(1,298 |
) |
|
|
-36 |
% |
Net loss before income taxes |
|
|
(84,882 |
) |
|
|
(45,195 |
) |
|
|
(39,687 |
) |
|
|
88 |
% |
Provision for income taxes |
|
|
50 |
|
|
|
— |
|
|
|
50 |
|
|
|
100 |
% |
Net loss |
|
$ |
(84,832 |
) |
|
$ |
(45,195 |
) |
|
$ |
(39,637 |
) |
|
|
88 |
% |
Net loss per share - basic and diluted |
|
$ |
(0.99 |
) |
|
$ |
(0.65 |
) |
|
$ |
(0.34 |
) |
|
|
52 |
% |
Weighted average shares outstanding - basic and diluted |
|
|
85,999 |
|
|
|
69,767 |
|
|
|
16,232 |
|
|
|
23 |
% |
Product Sales, Net
Product sales, net decreased by $0.2 million, or 35%, to $0.5 million for the three months ended March 31, 2026 compared to the same period the prior year. This decrease was primarily attributable to the termination of the ANI commercial supply agreement (CSA) in the second quarter of 2025.
License and Collaboration Agreement
License and collaboration agreement revenue decreased by $11.0 million, or 99%, to $0.1 million for the three months ended March 31, 2026 compared to the same period the prior year. This decrease was primarily driven by the recognition of remaining deferred revenue related to our 2023 agreement for the license of YUTIQ® product rights in the second quarter of 2025.
Royalty Income
Royalty income decreased by $12.5 million, or 99%, to $0.1 million for the three months ended March 31, 2026 compared to the same period the prior year. This decrease was due to the termination of the SWK royalty purchase agreement (RPA) on March 18, 2025.
Cost of Sales
Cost of sales decreased by $0.3 million, or 34%, to $0.5 million for the three months ended March 31, 2026 compared to the same period the prior year. This decrease was primarily attributable to lower commercial product sales year over year.
21
Research and Development
The following table summarizes our research and development expenses for the three months ended March 31, 2026 and 2025:
|
|
Three Months Ended |
|
|||||
|
|
March 31, |
|
|||||
|
|
2026 |
|
|
2025 |
|
||
Direct research and development expenses by program: |
|
|
|
|
|
|
||
DURAVYU |
|
$ |
46,852 |
|
|
$ |
41,898 |
|
Other direct research and development |
|
|
605 |
|
|
|
985 |
|
Unallocated expenses: |
|
|
|
|
|
|
||
Personnel (including stock based compensation) |
|
|
20,426 |
|
|
|
12,386 |
|
Facilities |
|
|
991 |
|
|
|
896 |
|
Other |
|
|
3,274 |
|
|
|
2,409 |
|
Total research and development expenses |
|
|
72,148 |
|
|
|
58,574 |
|
Research and development expenses increased by $13.6 million, or 23%, to $72.1 million for the three months ended March 31, 2026 compared to the same period the prior year. This increase was primarily attributable to ongoing DURAVYU Phase 3 clinical trials for wet AMD and DME and scale-up of the Northbridge commercial manufacturing facility.
Sales and Marketing
Sales and marketing expenses remained consistent and immaterial for the three months ended March 31, 2026 compared to the same period the prior year.
General and Administrative
General and administrative expenses increased by $1.4 million, or 10%, to $15.2 million for the three months ended March 31, 2026 compared to the same period the prior year. This increase was primarily attributable to increased personnel costs, including non-cash stock compensation.
Interest (Expense) Income
Interest (expense) income decreased by $1.3 million, or 36%, to $2.3 million for the three months ended March 31, 2026 compared to the same period the prior year. This decrease was primarily driven by lower cash available for investment in marketable securities.
Liquidity and Capital Resources
We have had a history of operating losses and an absence of significant recurring cash inflows from revenue, and at March 31, 2026 we had a total accumulated deficit of $1,189.8 million. Our operations have been financed primarily from sales of our equity securities, issuance of debt and a combination of license fees, milestone payments, royalty income and other fees received from collaboration partners.
Financing Activities
In August 2020, we entered into an at-the-market facility (the ATM Facility) with Cantor Fitzgerald & Co (Cantor). Pursuant to the ATM Facility, we may, at our option, offer and sell shares of its common stock from time to time, through or to Cantor, acting as sales agent. We will pay Cantor a commission of 3.0% of the gross proceeds from any future sales of such shares. During the three months ended March 31, 2026 and 2025, we did not sell any shares of our common stock under our ATM offering facility.
Future Funding Requirements
At March 31, 2026, we had cash, cash equivalents, and investments in marketable securities of $222.5 million. We expect that our cash and investments in marketable securities will enable us to fund our operations into the fourth quarter of 2027. Due to the difficulty and uncertainty associated with the design and implementation of clinical trials, we will continue to assess our cash and cash equivalents, investments in marketable securities, and future funding requirements. However, there is no assurance that additional funding will be achieved and that we will succeed in our future operations. We expect to continue to incur substantial additional operating losses for at least the next several years as we continue to develop our product candidates and seek marketing approval and,
22
subject to obtaining such approval, the eventual commercialization of our product candidates. If we obtain marketing approval for any of our product candidates, we will incur significant sales, marketing, and manufacturing expenses. We also expect to continue to incur significant costs to comply with corporate governance, internal controls, and similar requirements associated with operating as a public reporting company.
Actual cash requirements could differ from management’s projections due to many factors including additional investments in research and development programs, clinical trial expenses for DURAVYU, competing technological and market developments and the costs of any strategic acquisitions and/or development of complementary business opportunities.
The amount of additional capital we will require will be influenced by many factors, including, but not limited to:
We expect to seek additional funding to sustain our future operations and while we have successfully raised capital in the past, the ability to raise capital in future periods is not assured. We do not know if additional capital will be available when needed or on terms favorable to us or our stockholders. Collaboration, licensing or other agreements may not be available on favorable terms, or at all. If we seek to sell our equity securities, we do not know whether and to what extent we will be able to do so, or on what terms. If available, additional equity financing may be dilutive to stockholders, debt financing may involve restrictive covenants or other unfavorable terms and dilute our existing stockholders’ equity, and funding through collaboration, licensing or other commercial agreements may be on unfavorable terms, including requiring us to relinquish rights to certain of our technologies or products. If adequate financing is not available if and when needed, we may delay, reduce the scope of, or eliminate research or development programs, if any, postpone or cancel the pursuit of product candidates, or otherwise significantly curtail our operations to reduce our cash requirements and extend our capital.
Our condensed consolidated statements of historical cash flows are summarized as follows (in thousands):
|
|
|
|
|
|
|
||||||
|
|
Three Months Ended |
|
|
|
|
||||||
|
|
March 31, |
|
|
|
|
||||||
|
|
2026 |
|
|
2025 |
|
|
Change |
|
|||
Cash flows from operating activities: |
|
|
|
|
|
|
|
|
|
|||
Net loss |
|
$ |
(84,832 |
) |
|
$ |
(45,195 |
) |
|
$ |
(39,637 |
) |
Changes in operating assets and liabilities |
|
|
(7,213 |
) |
|
|
(14,509 |
) |
|
|
7,296 |
|
Other adjustments to reconcile net loss to cash flows from |
|
|
11,496 |
|
|
|
6,584 |
|
|
|
4,912 |
|
Net cash (used in) provided by operating activities |
|
$ |
(80,549 |
) |
|
$ |
(53,120 |
) |
|
$ |
(27,429 |
) |
Net cash (used in) provided by investing activities |
|
$ |
59,054 |
|
|
$ |
39,525 |
|
|
$ |
19,529 |
|
Net cash (used in) provided by financing activities |
|
$ |
(2,614 |
) |
|
$ |
(951 |
) |
|
$ |
(1,663 |
) |
Operating cash outflows for the three months ended March 31, 2026 totaled $80.5 million primarily due to our net loss of $84.8 million reduced by $11.5 million of non-cash expenses, which was primarily attributable to $11.6 million of stock-based compensation. We incurred cash outflows of $7.2 million in other working capital adjustments driven primarily by increased prepaid clinical expenses.
23
Operating cash outflows for the three months ended March 31, 2025 totaled $53.1 million primarily due to our net loss of $45.2 million reduced by $6.6 million of non-cash expenses, which included $7.8 million of stock-based compensation, partially offset by $1.7 million for amortization of discount on available for sale of marketable securities. We incurred cash outflows related to changes in working capital of $14.5 million, which included $23.5 million of deferred revenue related to the agreement to license YUTIQ® product rights to ANI offset by $9.0 million in other working capital adjustments.
For the three months ended March 31, 2026, $60.1 million of net cash was provided by investing activities from the sales of marketable securities, offset by $1.0 million used for the purchase of property and equipment.
For the three months ended March 31, 2025, $39.8 million of net cash was provided by investing activities from the sales of marketable securities, and $0.3 million was used for the purchase of property and equipment.
Net cash used in financing activities for the three months ended March 31, 2026 totaled $2.6 million and consisted mainly of the following:
Net cash used in financing activities for the three months ended March 31, 2025 totaled $1.0 million and consisted mainly of the following:
Item 3. Quantitative and Qualitative Disclosures about Market Risk
We are a smaller reporting company as defined by Rule 12b-2 of the Securities Exchange Act of 1934, as amended, and are not required to provide the information under this item.
Item 4. Controls and Procedures
Evaluation of Disclosure Controls and Procedures
Our management, with the participation of our principal executive officer and principal financial officer, evaluated the effectiveness of our disclosure controls and procedures as of March 31, 2026. The term "disclosure controls and procedures," as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act, means controls and other procedures of an issuer that are designed to ensure that information required to be disclosed by the issuer 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 Commission's rules and forms. Disclosure controls and procedures include, without limitation, controls and procedures designed to ensure that information required to be disclosed by an issuer in the reports that it files or submits under the Exchange Act is accumulated and communicated to the issuer's management, including its principal executive and principal financial officers, or persons performing similar functions, as appropriate to allow timely decisions regarding required disclosure, particularly during the period in which this Quarterly Report on Form 10-Q was being prepared.
Management recognizes that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving its desired objectives, and our management necessarily applies its judgment in evaluating the cost-benefit relationship of possible controls and procedures. Based on the evaluation of our disclosure controls and procedures as of March 31, 2026, our principal executive officer and principal financial officer concluded that, as of such date, our disclosure controls and procedures were effective at the reasonable assurance level.
Changes in Internal Control over Financial Reporting
There were no changes in our internal control over financial reporting during the quarter ended March 31, 2026 covered by this Quarterly Report on Form 10-Q that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.
24
PART II: OTHER INFORMATION
Item 1. Legal Proceedings
DOJ Subpoena
As previously reported, in August 2022, we received a subpoena from the U.S. Attorney’s Office for the District of Massachusetts (DOJ), seeking production of documents related to sales, marketing, and promotional practices, including as pertain to DEXYCU®, which we commercialized from 2019 to 2023 (the “DOJ Subpoena”). More information pertaining to the DOJ Subpoena can be found in Note 12. Contingencies, to the Notes to Consolidated Financial Statements (Part I, Item 1 of this Quarterly Report on Form 10-Q).
Ocular Therapeutix, Inc.
On March 20, 2026, we filed a complaint (the “Complaint”) against Ocular Therapeutix, Inc. (“Ocular”) in the Middlesex County Superior Court for the Commonwealth of Massachusetts (the “Court”). The Complaint alleges, among other things, Ocular's dissemination of false or misleading representations of fact concerning our company and the clinical results of our lead product candidate, DURAVYU™ (vorolanib intravitreal insert). The Complaint asserts several causes of action against Ocular, including defamation, commercial disparagement, violation of Mass. Gen. L. c. 93A, §§ 2 and 11, and tortious interference with advantageous business relations. We are seeking injunctive relief preventing Ocular from further disseminating the false or misleading representations of fact, requiring its public retraction of the false and misleading statements, monetary damages in the amount to be determined at trial, attorneys’ fees and costs, and such other relief that the court deems just and proper. Ocular filed its answer on April 13, 2026, seeking judgment in its favor, dismissal with prejudice of all claims, award of attorneys’ fees, costs, and expenses incurred in connection with the action, and such other and further relief as the court deems appropriate. On April 13, 2026, the Court declined to impose a temporary restraining order, but convened a preliminary injunction hearing that began on May 5, 2026 and is scheduled to continue on June 10, 2026.
Item 1A. Risk Factors
This section augments and updates certain risk factors disclosed in Item 1A of Part I of our Annual Report on Form 10-K for the year ended December 31, 2025 (the Annual Report). The following risk factors should be read together with the other risk factors disclosed in the Annual Report. In addition to the other information in this Quarterly Report on Form 10-Q, all of the risk factors should be carefully considered in evaluating us and our common stock. Any of these risks, many of which are beyond our control, could materially and adversely affect our financial condition, results of operations or cash flows, or cause our actual results to differ materially from those projected in any forward-looking statements. We may also face other risks and uncertainties that are not presently known, are not currently believed to be material, or are not identified below because they are common to all businesses. Past financial performance may not be a reliable indicator of future performance, and historical trends should not be used to anticipate results or trends in future periods. For more information, see “Note Regarding Forward-Looking Statements” in this Quarterly Report on Form 10-Q.
RISKS RELATED TO OWNERSHIP OF OUR COMMON STOCK
The trading price of the shares of our common stock has been highly volatile, and purchasers of our common stock could incur substantial losses.
The price of our common stock is highly volatile and may be affected by developments directly affecting our business, as well as by developments out of our control or not specific to us. The pharmaceutical and biotechnology industries, in particular, and the stock market generally, are vulnerable to abrupt changes in investor sentiment. Prices of securities and trading volumes of companies in the pharmaceutical and biotechnology industries, including ours, can swing dramatically in ways unrelated to, or that bear a disproportionate relationship to, our performance. The price of our common stock and their trading volumes may fluctuate based on a number of factors including, but not limited to:
25
In addition, low trading volume in our common stock may increase their price volatility. Holders of our common stock may not be able to liquidate their positions at the desired time or price.
We have initiated legal proceedings and may in the future become subject to litigation, which could harm our business, financial condition, stock price and reputation.
We are involved, and may become involved in the future, in disputes and other legal proceedings that could be costly and time-consuming to prosecute or defend and result in unfavorable outcomes, which may have a material adverse effect on our business, operating results and financial condition, and negatively affect the price of our common stock. For example, on March 20, 2026, we filed a complaint against Ocular Therapeutix, Inc. (“Ocular”), in the Middlesex County Superior Court for the Commonwealth of Massachusetts. The complaint alleges, among other things, Ocular’s dissemination of false or misleading representations of fact concerning our company and the clinical results of DURAVYU, our lead product candidate (the “Ocular Litigation”). The complaint asserts several causes of action against Ocular, including defamation, commercial disparagement, violation of Mass. Gen. L. c. 93A, §§ 2 and 11, and tortious interference with advantageous business relations. We are seeking injunctive relief preventing Ocular from further disseminating the false or misleading representations of fact, requiring its public retraction of the false and misleading statements, monetary damages in the amount to be determined at trial, attorneys’ fees and costs, and such other relief that the court deems just and proper. Ocular filed its answer on April 13, 2026, seeking judgment in its favor, dismissal with prejudice of all claims, award of attorneys’ fees, costs, and expenses incurred in connection with the action, and such other and further relief as the court deems appropriate. We cannot predict whether the Ocular Litigation or any future legal matter will be resolved favorably for us. Legal proceedings in general, regardless of their merits or their ultimate outcomes, can be expensive and time-consuming to bring or defend against, requiring us to expend significant resources and divert the effort and attention of our management and other personnel from our business operations. The Ocular Litigation and any future litigation may adversely affect our business, results of operations, financial condition, prospects, and stock price. Furthermore, publicity surrounding legal proceedings, even if resolved favorably for us, could result in additional legal proceedings, damage to our reputation and cause volatility in our stock price.
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds
None.
Item 3. Defaults Upon Senior Securities
None.
Item 4. Mine Safety Disclosures
None.
Item 5. Other Information
(c)
26
Rule 10b5-1 Trading Arrangements
The Company permits officers and directors to adopt written trading plans, known as “Rule 10b5-1 trading arrangements”, as such term defined in Item 408(a) of Regulation S-K for the purchase or sale of the Company's securities, which are intended to satisfy the affirmative defense conditions of Rule 10b5-1(c) under the Exchange Act. During the three months ended March 31, 2026,
27
Item 6. Exhibits
|
|
|
|
Incorporated by Reference to SEC Filing |
||||
Exhibit No. |
|
Exhibit Description |
|
Form |
|
SEC Filing Date |
|
Exhibit No. |
|
|
|
|
|
|
|
|
|
2.1# |
|
Product Rights Agreement, dated May 17, 2023, by and between EyePoint Pharmaceuticals, Inc. and Alimera Sciences, Inc. |
|
8-K |
|
05/18/23 |
|
2.1 |
|
|
|
|
|
|
|
|
|
3.1 |
|
Certificate of Incorporation of pSivida Corp. |
|
8-K12G3 |
|
06/19/08 |
|
3.1 |
|
|
|
|
|
|
|
|
|
3.2 |
|
Certificate of Amendment of the Certificate of Incorporation of pSivida Corp. |
|
10-K |
|
09/13/17 |
|
3.2 |
|
|
|
|
|
|
|
|
|
3.3 |
|
Certificate of Correction to Certificate of Amendment of the Certificate of Incorporation of pSivida Corp. |
|
8-K |
|
04/02/18 |
|
3.1 |
|
|
|
|
|
|
|
|
|
3.4 |
|
Certificate of Amendment of Certificate of Incorporation, as amended, of EyePoint Pharmaceuticals, Inc. |
|
8-K |
|
06/27/18 |
|
3.1 |
|
|
|
|
|
|
|
|
|
3.5
|
|
Certificate of Amendment of the Certificate of Incorporation, as amended, of EyePoint Pharmaceuticals, Inc. |
|
8-K |
|
06/23/20 |
|
3.1 |
|
|
|
|
|
|
|
|
|
3.6
|
|
Certificate of Amendment of the Certificate of Incorporation, as amended, of EyePoint Pharmaceuticals, Inc. |
|
8-K |
|
12/08/20 |
|
3.1 |
|
|
|
|
|
|
|
|
|
3.7 |
|
Certificate of Amendment to Certificate of Incorporation, as amended, of EyePoint, Inc. |
|
8-K
|
|
12/08/25
|
|
3.1 |
|
|
|
|
|
|
|
|
|
3.8 |
|
By-Laws of EyePoint Pharmaceuticals, Inc. |
|
10-K |
|
09/18/18 |
|
3.5
|
|
|
|
|
|
|
|
|
|
3.9 |
|
Amendment No. 1 to the By-Laws of EyePoint Pharmaceuticals, Inc. |
|
8-K |
|
11/06/18 |
|
3.1 |
|
|
|
|
|
|
|
|
|
3.10 |
|
Amendment No. 2 to the By-Laws of EyePoint, Inc. |
|
8-K |
|
12/08/25 |
|
3.2 |
|
|
|
|
|
|
|
|
|
4.1 |
|
Form of Specimen Stock Certificate for Common Stock |
|
8-K12G3 |
|
06/19/08 |
|
4.1 |
|
|
|
|
|
|
|
|
|
4.2 |
|
Form of Pre-Funded Warrant to Purchase Common Stock |
|
8-K |
|
11/19/21 |
|
4.1 |
|
|
|
|
|
|
|
|
|
4.3 |
|
Form of Pre-Funded Warrant to Purchase Common Stock (2025) |
|
8-K |
|
10/17/25 |
|
4.1 |
|
|
|
|
|
|
|
|
|
10.1† |
|
Third Amendment to Employment Agreement, dated March 5, 2026, by and between EyePoint, Inc. and Jay S. Duker. |
|
10-K |
|
03/05/26 |
|
10.22(a) |
|
|
|
|
|
|
|
|
|
10.2† |
|
First Amendment to Employment Agreement, dated March 5, 2026, by and between EyePoint, Inc. and George O. Elston. |
|
10-K |
|
03/05/26 |
|
10.23(a) |
|
|
|
|
|
|
|
|
|
10.3† |
|
First Amendment to Employment Agreement, dated March 5, 2026, by and between EyePoint, Inc. and Ramiro Ribeiro, M.D., Ph.D. |
|
10-K |
|
03/05/26 |
|
10.24(a) |
|
|
|
|
|
|
|
|
|
31.1* |
|
Certification of Principal Executive Officer pursuant to Rule 13a-14(a) and Rule 15d-14(a) of the Securities Exchange Act, as amended, as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
31.2* |
|
Certification of Principal Financial Officer pursuant to Rule 13a-14(a) and Rule 15d-14(a) of the Securities Exchange Act, as amended, as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
32.1** |
|
Certification of Principal Executive Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
32.2** |
|
Certification of Principal Financial Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
28
101.INS |
Inline XBRL Instance Document – the instance document does not appear in the Interactive Data File because XBRL tags are embedded within the Inline XBRL document. |
101.SCH |
Inline XBRL Taxonomy Extension Schema Document |
104 |
Cover Page Interactive Data File (embedded within the inline XBRL document and included in Exhibit 101) |
# Portions of this exhibit have been omitted in compliance with Item 601 of Regulation S-K.
† Indicates management contract or compensatory arrangement.
* Filed herewith
** Furnished herewith
29
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.
|
EyePoint, Inc. |
|
|
|
|
Date: May 7, 2026 |
By: |
/s/ Jay S. Duker |
|
Name: |
Jay S. Duker, M.D. |
|
Title: |
President and Chief Executive Officer (Principal Executive Officer) |
|
|
|
Date: May 7, 2026 |
By: |
/s/ George O. Elston |
|
Name: |
George O. Elston |
|
Title: |
Executive Vice President and Chief Financial Officer (Principal Financial Officer and Principal Accounting Officer) |
30