EyePoint plans roughly 53% workforce cut
Sentiment and the balance of points
Rhea-AI Sentiment reads the wording of the document, how positive or negative its language is on a 1 to 5 scale. The balance of points shown with the takes weighs what the document actually discloses, so the two can disagree, for example when a trial that missed its main goal is described in upbeat language.
EyePoint, Inc. (EYPT) reported nine-month 2026 revenue of $2.0 million, down 94% year over year, and a net loss of $274.9 million, versus $164.4 million. The revenue decline reflected lower license and royalty revenue, including prior-year YUTIQ license revenue and the end of the SWK royalty agreement. Research and development expense rose 47% to $237.4 million as Phase 3 trials and manufacturing scale-up continued.
Neither pivotal Phase 3 wet AMD trial met its primary endpoint of statistical non-inferiority against aflibercept. EyePoint plans to end the trials early while allowing additional patients to complete year two. Its Phase 3 DME trials are ongoing, with over 550 patients enrolled and initial results expected early in the fourth quarter of 2027. The board’s plan reduces the workforce by approximately 53%; estimated employee-separation charges are $9.0 million, with most expected in the fourth quarter of 2026.
Cash, cash equivalents and marketable securities totaled $118.2 million at September 30, 2026. After quarter-end, EyePoint sold 22,992,900 shares through its at-the-market facility at a weighted average $0.44 per share for approximately $10.1 million gross. Management expects funding into late Q3 2027 with operating adjustments, but says substantial doubt about continuing as a going concern remains.
How this balance works
Rhea-AI gives every point it takes from this document a weight. Minor counts 1, Moderate 3 and Major 9, so one Major point outweighs several Minor ones. The bar adds up the weights on each side, and when neither side holds more than 65% of the total the balance reads Mixed.
It reads the document as published, with the same rules for every company, and it does not look at what the market expected or at how the stock traded, so a point can be objectively good on a day the stock falls.
Rhea-AI Sentiment measures something else, the tone of the wording.
Positive
- None.
Negative
- Major pointSubstantial doubt remains about EyePoint’s ability to continue as a going concern.
- Major pointNine-month net loss widened 67% to $274.9 million.
- Major pointBoth pivotal wet AMD trials missed primary non-inferiority endpoints versus aflibercept.
- Moderate pointNine-month revenue fell 94% to $2.0 million.
Filing Explained
The cash settlement is complete, while the five-year compliance-program commitment remains in effect.
After
EyePoint agreed to pay
On
Key Figures
Key Terms
going concern financial
statistical non-inferiority medical
best corrected visual acuity medical
Durasert E™ technical
tyrosine kinase inhibitor medical
at-the-market facility financial
FAQ
AI-generated questions and answers. How Rhea-AI works. Not financial advice.
What were EyePoint’s revenue and net loss for the first nine months of 2026?
How long does EyePoint expect its cash to last?
How much did EyePoint pay under its DOJ settlement?
AI-generated analysis. How Rhea-AI works. Not financial advice.
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)
(State or other jurisdiction of incorporation or organization) |
|
(I.R.S. Employer Identification No.) |
|
|
|
(Address of principal executive offices) |
|
(Zip Code) |
(
(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:
Title of each class |
Trading Symbol(s) |
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 |
☐ |
|
Accelerated filer |
☐ |
☒ |
|
Smaller reporting company |
||
|
|
|
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
|
|
|
|
Page |
PART I. FINANCIAL INFORMATION |
|
|
||
|
|
|
|
|
Item 1. |
|
Unaudited Financial Statements |
|
|
|
|
|
|
|
|
|
Condensed Consolidated Balance Sheets – September 30, 2026 and December 31, 2025 |
|
3 |
|
|
|
|
|
|
|
Condensed Consolidated Statements of Operations and Comprehensive Loss –Three and nine months ended September 30, 2026 and 2025 |
|
4 |
|
|
|
|
|
|
|
Condensed Consolidated Statements of Stockholders’ Equity – Three and nine months ended September 30, 2026 and 2025 |
|
5 |
|
|
|
|
|
|
|
Condensed Consolidated Statements of Cash Flows – Nine months ended September 30, 2026 and 2025 |
|
7 |
|
|
|
|
|
|
|
Notes to Condensed Consolidated Financial Statements |
|
8 |
|
|
|
|
|
Item 2. |
|
Management’s Discussion and Analysis of Financial Condition and Results of Operations |
|
20 |
|
|
|
|
|
Item 3. |
|
Quantitative and Qualitative Disclosures about Market Risk |
|
30 |
|
|
|
|
|
Item 4. |
|
Controls and Procedures |
|
30 |
|
|
|
|
|
PART II: OTHER INFORMATION |
|
|
||
|
|
|
|
|
Item 1. |
|
Legal Proceedings |
|
31 |
|
|
|
|
|
Item 1A. |
|
Risk Factors |
|
31 |
|
|
|
|
|
Item 2. |
|
Unregistered Sales of Equity Securities and Use of Proceeds |
|
33 |
|
|
|
|
|
Item 3. |
|
Defaults Upon Senior Securities |
|
33 |
|
|
|
|
|
Item 4. |
|
Mine Safety Disclosures |
|
33 |
|
|
|
|
|
Item 5. |
|
Other Information |
|
33 |
|
|
|
|
|
Item 6. |
|
Exhibits |
|
35 |
|
|
|
|
|
Signatures |
|
37 |
||
2
PART I. FINANCIAL INFORMATION
Item 1. Unaudited Financial Statements
EYEPOINT, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED BALANCE SHEETS
(Unaudited)
(In thousands except share data)
|
|
September 30, |
|
|
December 31, |
|
||
|
|
2026 |
|
|
2025 |
|
||
Assets |
|
|
|
|
|
|
||
Current assets: |
|
|
|
|
|
|
||
Cash and cash equivalents |
|
$ |
|
|
$ |
|
||
Marketable securities |
|
|
|
|
|
|
||
Accounts and other receivables, net |
|
|
|
|
|
|
||
Prepaid expenses and other current assets |
|
|
|
|
|
|
||
Inventory |
|
|
|
|
|
|
||
Total current assets |
|
|
|
|
|
|
||
Property and equipment, net |
|
|
|
|
|
|
||
Operating lease right-of-use assets |
|
|
|
|
|
|
||
Restricted cash |
|
|
|
|
|
|
||
Other assets |
|
|
|
|
|
|
||
Total assets |
|
$ |
|
|
$ |
|
||
Liabilities and stockholders' equity |
|
|
|
|
|
|
||
Current liabilities: |
|
|
|
|
|
|
||
Accounts payable |
|
$ |
|
|
$ |
|
||
Accrued expenses |
|
|
|
|
|
|
||
Other current liabilities |
|
|
|
|
|
|
||
Total current liabilities |
|
|
|
|
|
|
||
Operating lease liabilities – noncurrent |
|
|
|
|
|
|
||
Other noncurrent liabilities |
|
|
|
|
|
|
||
Total liabilities |
|
|
|
|
|
|
||
Contingencies (Note 12) |
|
|
|
|
|
|
||
Stockholders' equity: |
|
|
|
|
|
|
||
Preferred stock, $ |
|
|
|
|
|
|
||
Common stock, $ |
|
|
|
|
|
|
||
Additional paid-in capital |
|
|
|
|
|
|
||
Accumulated deficit |
|
|
( |
) |
|
|
( |
) |
Accumulated other comprehensive income (loss) |
|
|
|
|
|
|
||
Total stockholders' equity |
|
|
|
|
|
|
||
Total liabilities and stockholders' equity |
|
$ |
|
|
$ |
|
||
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)
|
|
Three Months Ended |
|
|
Nine Months Ended |
|
||||||||||
|
|
September 30, |
|
|
September 30, |
|
||||||||||
|
|
2026 |
|
|
2025 |
|
|
2026 |
|
|
2025 |
|
||||
Revenues: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Product sales, net |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
License and collaboration agreements |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Royalty income |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Total revenues |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Cost of sales |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Research and development |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Sales and marketing |
|
|
|
|
|
|
|
|
|
|
|
|
||||
General and administrative |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Total operating expenses |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Loss from operations |
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
Other (expense) income: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Interest and other income, net |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Total other income, net |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Net loss before income taxes |
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
( |
) |
Provision for income taxes |
|
|
|
|
|
|
|
|
|
|
|
( |
) |
|||
Net loss |
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
( |
) |
Net loss per share: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Basic and diluted |
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
( |
) |
Weighted average common shares outstanding: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Basic and diluted |
|
|
|
|
|
|
|
|
|
|
|
|
||||
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
Net loss |
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
( |
) |
Other comprehensive income (loss): |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Unrealized gain (loss) on available-for-sale |
|
|
|
|
|
|
|
|
( |
) |
|
|
( |
) |
||
Comprehensive income (loss) |
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
( |
) |
See notes to condensed consolidated financial statements.
4
EYEPOINT, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS' EQUITY
(Unaudited)
(In thousands except share data)
|
Common Stock |
|
|
Additional |
|
|
|
|
|
Accumulated |
|
|
Total |
|
|||||||||
|
Number of |
|
|
Par Value |
|
|
Paid-In |
|
|
Accumulated |
|
|
Comprehensive |
|
|
Stockholders’ |
|
||||||
Balance at June 30, 2025 |
|
|
|
$ |
|
|
$ |
|
|
$ |
( |
) |
|
$ |
|
|
$ |
|
|||||
Net loss |
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
( |
) |
|
|
— |
|
|
|
( |
) |
Unrealized gain (loss) on available-for-sale securities |
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
|
|
|
||
Issuance of stock, net of issue costs |
|
|
|
|
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
|
||||
Employee stock purchase plan |
|
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
|
|||
Exercise of stock options |
|
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
|
|||
Vesting of stock units |
|
|
|
|
|
|
|
( |
) |
|
|
— |
|
|
|
— |
|
|
|
( |
) |
||
Stock-based compensation |
|
— |
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
|
||
Balance at September 30, 2025 |
|
|
|
$ |
|
|
$ |
|
|
$ |
( |
) |
|
$ |
|
|
$ |
|
|||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||
Balance at June 30, 2026 |
|
|
|
$ |
|
|
$ |
|
|
$ |
( |
) |
|
$ |
|
|
$ |
|
|||||
Net loss |
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
( |
) |
|
|
— |
|
|
|
( |
) |
Unrealized gain (loss) on available-for-sale securities |
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
|
|
|
||
Issuance of stock, net of issue costs |
|
|
|
|
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
|
||||
Exercise of warrants |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||
Exercise of stock options |
|
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
|
|||
Employee stock purchase plan |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||
Stock units granted, net of units withheld for tax |
|
|
|
|
— |
|
|
|
( |
) |
|
|
— |
|
|
|
— |
|
|
|
( |
) |
|
Stock-based compensation |
|
— |
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
|
||
Balance at September 30, 2026 |
|
|
|
$ |
|
|
$ |
|
|
$ |
( |
) |
|
$ |
|
|
$ |
|
|||||
5
|
Common Stock |
|
|
Additional |
|
|
|
|
|
Accumulated |
|
|
Total |
|
|||||||||
|
Number of |
|
|
Par Value |
|
|
Paid-In |
|
|
Accumulated |
|
|
Comprehensive |
|
|
Stockholders’ |
|
||||||
Balance at December 31, 2024 |
|
|
|
$ |
|
|
$ |
|
|
$ |
( |
) |
|
$ |
|
|
$ |
|
|||||
Net loss |
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
( |
) |
|
|
— |
|
|
|
( |
) |
Unrealized gain (loss) on available-for-sale securities |
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
( |
) |
|
|
( |
) |
Issuance of stock, net of issue costs |
|
|
|
|
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
|
||||
Employee stock purchase plan |
|
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
|
|||
Exercise of stock options |
|
|
|
|
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
|
||||
Vesting of stock units |
|
|
|
|
— |
|
|
|
( |
) |
|
|
— |
|
|
|
— |
|
|
|
( |
) |
|
Stock-based compensation |
|
— |
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
|
||
Balance at September 30, 2025 |
|
|
|
$ |
|
|
$ |
|
|
$ |
( |
) |
|
$ |
|
|
$ |
|
|||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||
Balance at December 31, 2025 |
|
|
|
$ |
|
|
$ |
|
|
$ |
( |
) |
|
$ |
|
|
$ |
|
|||||
Net loss |
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
( |
) |
|
|
— |
|
|
|
( |
) |
Unrealized gain (loss) on available-for-sale securities |
|
|
|
|
|
|
|
|
|
|
|
|
|
( |
) |
|
|
( |
) |
||||
Issuance of stock, net of issue costs |
|
|
|
|
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
|
||||
Exercise of warrants |
|
|
|
|
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
|
||||
Employee stock purchase plan |
|
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
|
|||
Exercise of stock options |
|
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
|
|||
Stock units granted, net of units withheld for tax |
|
|
|
|
|
|
|
( |
) |
|
|
— |
|
|
|
— |
|
|
|
( |
) |
||
Stock-based compensation |
|
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
|
|||
Balance at September 30, 2026 |
|
|
|
$ |
|
|
$ |
|
|
$ |
( |
) |
|
$ |
|
|
$ |
|
|||||
See notes to condensed consolidated financial statements.
6
EYEPOINT, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(Unaudited)
(In thousands)
|
|
Nine Months Ended |
|
|||||
|
|
September 30, |
|
|||||
|
|
2026 |
|
|
2025 |
|
||
Cash flows from operating activities: |
|
|
|
|
|
|
||
Net loss |
|
$ |
( |
) |
|
$ |
( |
) |
Adjustments to reconcile net loss to cash flows used in |
|
|
|
|
|
|
||
Depreciation of property and equipment |
|
|
|
|
|
|
||
Gain on sale of equity investment |
|
|
( |
) |
|
|
|
|
Amortization of debt discount and premium and discount on |
|
|
( |
) |
|
|
( |
) |
Stock-based compensation |
|
|
|
|
|
|
||
Deferred income tax |
|
|
|
|
|
( |
) |
|
Changes in operating assets and liabilities: |
|
|
|
|
|
|
||
Accounts receivable and other current assets |
|
|
|
|
|
|
||
Other assets |
|
|
( |
) |
|
|
( |
) |
Inventory |
|
|
|
|
|
|
||
Accounts payable and accrued expenses |
|
|
|
|
|
( |
) |
|
Right-of-use assets and operating lease liabilities |
|
|
( |
) |
|
|
|
|
Deferred revenue |
|
|
|
|
|
( |
) |
|
Other noncurrent liabilities |
|
|
( |
) |
|
|
( |
) |
Net cash (used in) provided by operating activities |
|
|
( |
) |
|
|
( |
) |
Cash flows from investing activities: |
|
|
|
|
|
|
||
Purchases of marketable securities |
|
|
( |
) |
|
|
( |
) |
Sales and maturities of marketable securities |
|
|
|
|
|
|
||
Proceeds from sale of equity investment |
|
|
|
|
|
|
||
Purchases of property and equipment |
|
|
( |
) |
|
|
( |
) |
Net cash (used in) provided by investing activities |
|
|
|
|
|
|
||
Cash flows from financing activities: |
|
|
|
|
|
|
||
Proceeds from issuance of stock |
|
|
|
|
|
|
||
Proceeds from exercise of warrants |
|
|
|
|
|
|
||
Payment of equity issue costs |
|
|
( |
) |
|
|
( |
) |
Net settlement of stock units to satisfy statutory tax withholding |
|
|
( |
) |
|
|
( |
) |
Proceeds from exercise of stock options and employee stock purchase plan |
|
|
|
|
|
|
||
Principal payments on finance lease obligations |
|
|
( |
) |
|
|
( |
) |
Net cash (used in) provided by financing activities |
|
|
|
|
|
|
||
Net (decrease) increase in cash, cash equivalents and restricted cash |
|
|
( |
) |
|
|
( |
) |
Cash, cash equivalents and restricted cash at beginning of period |
|
|
|
|
|
|
||
Cash, cash equivalents and restricted cash at end of period |
|
$ |
|
|
$ |
|
||
Reconciliation of cash, cash equivalents and restricted cash to the condensed consolidated balance sheets: |
|
|
|
|
|
|
||
Cash and cash equivalents |
|
$ |
|
|
$ |
|
||
Restricted cash |
|
|
|
|
|
|
||
Total cash, cash equivalents and restricted cash at end of period |
|
$ |
|
|
$ |
|
||
Supplemental disclosure of non-cash investing and financing activities: |
|
|
|
|
|
|
||
Lease liability arising from obtaining right-of-use assets |
|
$ |
|
|
$ |
|
||
Stock issuance costs in accounts payable and accrued expenses |
|
$ |
|
|
$ |
|
||
|
|
|
|
|
|
|
||
See notes to condensed consolidated financial statements.
7
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 September 30, 2026 and for the three and nine months ended September 30, 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 and nine months ended September 30, 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™.
Topline data from the LUGANO and LUCIA clinical trials were announced on August 17, 2026 and October 19, 2026, respectively. Both trials did not meet the primary endpoint of non-inferiority change in best corrected visual acuity (BCVA) versus on-label aflibercept control despite demonstrating visual acuity improvements for a majority of patients and achieving key secondary endpoints including a continued favorable safety profile with redosing, reduction in treatment burden and percentage of patients supplement-free through Week 56. The Company announced a Strategic Prioritization (the "Prioritization") under which the pivotal Phase 3 wet AMD trials will be concluded early, without full completion of the second year of each trial, while also allowing additional patients to complete year two to support the necessary safety database for a potential new drug application for DME. The Company continues its evaluation of the full Phase 3 dataset for potential next steps for DURAVYU as a potential treatment for wet AMD. As a part of the Prioritization, the Company announced a reduction in workforce of approximately
Pivotal Phase 3 clinical trials (COMO and CAPRI) in diabetic macular edema (DME) are fully enrolled and ongoing. Both trials dosed the first patients in February 2026 and enrollment completion was announced in July 2026. With over 550 patients enrolled, the initial data readout for the DME program in both studies is expected early in the fourth quarter of 2027. Unlike wet AMD, DME is a multi-factorial exudative disease that involves both VEGF and inflammatory pathways, including interleukin 6 (IL-6)/JAK1 signaling, both potentially inhibited by vorolanib.
EyePoint is headquartered in Watertown, Massachusetts and has a commercial manufacturing facility in Northbridge, Massachusetts.
Liquidity and Ability to Continue as a Going Concern
The accompanying condensed consolidated financial statements are prepared in accordance with generally accepted accounting principles applicable to a going concern, which contemplates the realization of assets and the satisfaction of liabilities in the normal course of business.
The Company had cash, cash equivalents and investments in marketable securities of $
8
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.
Based on current operating plans and excluding future external financing, the Company will not have sufficient cash and cash equivalents to fund its operating expenses and capital requirements beyond one year from the issuance of these condensed consolidated financial statements. Actual cash requirements could differ from management’s projections due to many factors, including the timing and results of the Company’s clinical trials for DURAVYU, the impact of the Company’s strategic prioritization plan and accompanying reduction in force, and competing technological and market developments. These conditions and events raise substantial doubt about the Company’s ability to continue as a going concern.
In response to these conditions and events, the Company plans to seek additional funding through a combination of equity offerings, government or private-party grants, debt financings, or other capital sources, such as collaborations with other companies, strategic alliances, or licensing arrangements. The Company may not be able to obtain financing on acceptable terms, or at all, or enter into collaborative arrangements. Although management will continue to pursue these plans, there is no assurance that they will be successful or provide sufficient funding when needed. If the Company is unable to obtain funding, it could be forced to delay, reduce, or eliminate some or all of its research and development programs, including its clinical trials, pipeline expansion, or commercialization efforts, which could adversely affect its business prospects. Accordingly, management’s plans do not alleviate substantial doubt about the Company’s ability to continue as a going concern.
The accompanying condensed consolidated financial statements do not include any adjustments relating to the recoverability and classification of recorded asset amounts or the amounts and classification of liabilities that might result from the outcome of this uncertainty.
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
9
products, including YUTIQ®, for the treatment and prevention of uveitis in the entire world except Europe, the Middle East and Africa (EMEA).
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 $
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:
10
Revenue from sales of product supply to Ocumension under the supply agreement was $
Prepaid expenses and other current assets consisted of the following (in thousands):
|
|
September 30, |
|
|
December 31, |
|
||
Prepaid expenses |
|
$ |
|
|
$ |
|
||
Prepaid clinical expenses |
|
|
|
|
|
|
||
Other |
|
|
|
|
|
|
||
Total prepaid expenses and other current assets |
|
$ |
|
|
$ |
|
||
As of September 30, 2026 and December 31, 2025 the Company also had $
Inventory consisted of the following (in thousands):
|
|
September 30, |
|
|
December 31, |
|
||
Raw materials |
|
$ |
|
|
$ |
|
||
Work in process |
|
|
|
|
|
|
||
Total inventory |
|
$ |
|
|
$ |
|
||
As of September 30, 2026 and December 31, 2025,
Accrued expenses consisted of the following (in thousands):
|
|
September 30, |
|
|
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 entered into a lease agreement (Watertown Lease) for its new office space expansion located at 480 Pleasant Street, Watertown, Massachusetts and consists of
11
The Company determined the lease consists of a single lease component and no option to extend the expansion space exists. Variable lease payments, such as electricity costs are not included in the determination of the lease’s ROU asset or lease liability.
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.
As of September 30, 2026, the weighted average remaining term of the Company’s operating leases was
Supplemental balance sheet information related to operating leases are as follows (in thousands):
|
|
September 30, |
|
|
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 |
|
|
Nine Months Ended |
|
||||||||||
|
|
2026 |
|
|
2025 |
|
|
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 $
12
The Company’s total future minimum lease payments under non-cancellable leases at September 30, 2026 were as follows (in thousands):
|
|
Operating Leases |
|
|
Remainder of 2026 |
|
|
|
|
2027 |
|
|
|
|
2028 |
|
|
|
|
2029 |
|
|
|
|
2030 |
|
|
|
|
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 pays Cantor a commission of
During the three months ended September 30, 2026, the Company sold
During the nine months ended September 30, 2026, the Company sold
During the three and nine months ended September 30, 2025 the Company sold
Warrants to Purchase Common Shares
The Company issued
The Company issued
On August 18, 2026,
As of September 30, 2026 and 2025,
13
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 nine months ended September 30, 2026:
|
|
Number of |
|
|
Weighted |
|
|
Weighted |
|
|
Aggregate |
|
||||
|
|
|
|
|
|
|
|
(in years) |
|
|
(in thousands) |
|
||||
Outstanding at December 31, 2025 |
|
|
|
|
$ |
|
|
|
|
|
|
|
||||
Granted |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Exercised |
|
|
( |
) |
|
|
|
|
|
|
|
|
|
|||
Forfeited |
|
|
( |
) |
|
|
|
|
|
|
|
|
|
|||
Expired |
|
|
( |
) |
|
|
|
|
|
|
|
|
|
|||
Outstanding at September 30, 2026 |
|
|
|
|
$ |
|
|
|
|
|
$ |
|
||||
Exercisable at September 30, 2026 |
|
|
|
|
$ |
|
|
|
|
|
$ |
|
||||
The Company's stock options generally vest over
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.
14
The fair value of the share-based awards was measured with the following range of assumptions for the nine months ended September 30, 2026:
|
|
Nine Months Ended |
|
|
September 30, 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 nine months ended September 30, 2026 (in thousands except per share amount):
|
|
Nine Months Ended |
|
|
|
|
September 30, 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 nine months ended September 30, 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 nine months ended September 30, 2026:
|
|
Number of Restricted Stock Units |
|
|
Weighted Average Grant Date Fair Value |
|
||
Nonvested at December 31, 2025 |
|
|
|
|
$ |
|
||
Granted |
|
|
|
|
|
|
||
Vested |
|
|
( |
) |
|
|
|
|
Forfeited |
|
|
( |
) |
|
|
|
|
Nonvested at September 30, 2026 |
|
|
|
|
$ |
|
||
At September 30, 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
15
Company’s common stock each employee may purchase under this plan, when combined with all other employee stock purchase plans, is limited to the lower of an aggregate fair market value of $
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 and nine months ended September 30, 2026, 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 |
|
|
Nine Months Ended |
|
||||||||||
|
|
2026 |
|
|
2025 |
|
|
2026 |
|
|
2025 |
|
||||
Compensation expense included in: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Research and development |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
General and administrative |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Total |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
At September 30, 2026, there was approximately $
During the three and nine months ended September 30, 2026, the Company modified certain stock options in connection with expired term of service for a board member resulting in incremental expense of $
During the three and nine months ended September 30, 2025, the Company modified certain stock options in connection with the resignation of board members and terminations of executives resulting in incremental expense of $
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):
|
|
September 30, 2026 |
|
|||||||||||||||||||||
|
|
Carrying |
|
|
Gross |
|
|
Gross |
|
|
Fair Value |
|
|
Cash |
|
|
Marketable Securities |
|
||||||
Level 1: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||
Money market funds |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||||
Subtotal |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||||
Level 2: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||
U.S. Treasury securities |
|
$ |
|
|
$ |
|
|
$ |
( |
) |
|
$ |
|
|
$ |
|
|
$ |
|
|||||
U.S. Agency securities |
|
|
|
|
|
|
|
|
( |
) |
|
|
|
|
|
|
|
|
|
|||||
Subtotal |
|
$ |
|
|
$ |
|
|
$ |
( |
) |
|
$ |
|
|
$ |
|
|
$ |
|
|||||
Total |
|
$ |
|
|
$ |
|
|
$ |
( |
) |
|
$ |
|
|
$ |
|
|
$ |
|
|||||
16
|
|
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 September 30, 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
17
Significant segment expenses are as follows (in thousands):
|
Three Months Ended |
|
Nine Months Ended |
|
||||||||||||
|
|
September 30, |
|
|
September 30, |
|
||||||||||
|
|
2026 |
|
|
2025 |
|
|
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 |
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
Benefit (provision) for income taxes |
|
|
|
|
|
|
|
|
|
|
|
( |
) |
|||
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 Settlement
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 subpoena stemmed from a sealed qui tam complaint filed in the U.S. District Court for the District of Massachusetts. The DOJ investigation related to the False Claims Act and the Anti-Kickback Statute, and 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.
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 July 17, 2026 (the “Effective Date”) the Company entered into a settlement agreement (the “Settlement Agreement”) with the United States of America, acting through the DOJ and on behalf of HHS and the Defense Health Agency (“DHA”), acting on behalf of the TRICARE Program, and the relator named therein. Pursuant to the Settlement Agreement, the Company agreed, among other things, to pay a settlement amount of $
18
Integrity Agreement”) with HHS, which requires the Company to establish and maintain certain compliance programs for a five-year term, as more fully described in the Corporate Integrity Agreement. In exchange, HHS agreed not to seek the exclusion of the Company from participation in Medicare, Medicaid, or other federal health care programs as a result of the Covered Conduct.
On July 31, 2026, the Company paid the Settlement Payment in full and there was no accrual balance as of September 30, 2026.
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. Performance options have been excluded from the table below as the development and regulatory performance-based milestones have not been achieved nor were probable of achievement as of the end of the respective periods. See Note 9 for further detail.
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 September 30, |
|
|||||
|
|
2026 |
|
|
2025 |
|
||
Stock options |
|
|
|
|
|
|
||
ESPP |
|
|
|
|
|
|
||
Restricted stock units |
|
|
|
|
|
|
||
Total |
|
|
|
|
|
|
||
On October 17, 2026, following review of topline results from LUCIA, the second pivotal Phase 3 clinical trial evaluating DURAVYU™ for the treatment of wet AMD, the Board of Directors of the Company approved a strategic prioritization plan designed to reduce operating expenses and focus resources on the Company’s late-stage program for DURAVYU™ in DME. The Prioritization includes a plan to conclude the pivotal Phase 3 wet AMD clinical trials early, while also allowing additional patients to complete year two to support the necessary safety database for a potential new drug application for DME, and reduce the Company’s workforce by approximately
As a result of the Prioritization, the Company estimates it will incur aggregate charges of approximately $
The estimate of charges and expenditures that the Company expects to incur and the timing thereof are subject to a number of assumptions, and actual results may differ. As the Prioritization is implemented, the Company’s management will reevaluate the estimated charges and expenses set forth above and may revise them as appropriate, consistent with generally accepted accounting principles. The Company may also incur other non-cash charges or cash expenditures not currently contemplated due to events that may occur as a result of, or associated with, the Prioritization.
19
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:
20
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®, Durasert E™, DELIVERING INNOVATION TO THE EYE® and WITH AN EYE ON PATIENTS® are our trademarks. ILUVIEN® is ANI’s trademark. We assigned our trademarks for YUTIQ to Alimera Sciences, Inc. (which was acquired by ANI) and to Ocumension Therapeutics in their respective territories. 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 vorolanib, a selective and patent-protected tyrosine kinase inhibitor (TKI) with Durasert E™. EyePoint is headquartered in Watertown, Massachusetts and has 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)
21
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 currently being evaluated in Phase 3 clinical trials for the potential treatment of DME, the second largest retinal disease market. The first patients were dosed in both DME trials in February 2026, and enrollment completion was announced in July 2026. With over 550 patients enrolled, the initial data readout for the DME program in both studies is expected early in the fourth quarter of 2027.
Topline data from the LUGANO and LUCIA trials for DURAVYU in wet AMD were announced in August 2026 and October 2026, respectively, where the primary endpoint of statistical non-inferiority in mean change in best corrected visual acuity (BCVA) versus on-label 2 mg aflibercept control was not achieved despite visual acuity improvements for a majority of patients treated with DURAVYU. The Company announced plans to conclude the pivotal Phase 3 wet AMD trials early, without full completion of the second year of each trial, while also allowing additional patients to complete year two to support the necessary safety database for a potential new drug application for DME. We will complete additional analyses of both the LUGANO and LUCIA data along with the pooled Phase 3 datasets to further assess next steps for DURAVYU as a potential treatment for wet AMD.
Recent Developments
R&D Updates
22
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 condensed consolidated financial statements contained in this Quarterly Report on Form 10-Q for a description of our accounting policies and estimates.
23
Results of Operations
Three months ended September 30, 2026 Compared to Three months ended September 30, 2025 (In thousands except share data and percentages:
|
|
Three Months Ended |
|
|
|
|
||||||||||
|
|
September 30, |
|
|
Change |
|
||||||||||
|
|
2026 |
|
|
2025 |
|
|
Amounts |
|
|
% |
|
||||
Revenues: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Product sales, net |
|
$ |
528 |
|
|
$ |
582 |
|
|
$ |
(54 |
) |
|
|
-9 |
% |
License and collaboration agreements |
|
|
49 |
|
|
|
150 |
|
|
|
(101 |
) |
|
|
-67 |
% |
Royalty income |
|
|
179 |
|
|
|
234 |
|
|
|
(55 |
) |
|
|
-24 |
% |
Total revenues |
|
|
756 |
|
|
|
966 |
|
|
|
(210 |
) |
|
|
-22 |
% |
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Cost of sales |
|
|
523 |
|
|
|
721 |
|
|
|
(198 |
) |
|
|
-27 |
% |
Research and development |
|
|
81,670 |
|
|
|
47,754 |
|
|
|
33,916 |
|
|
|
71 |
% |
Sales and marketing |
|
|
31 |
|
|
|
26 |
|
|
|
5 |
|
|
|
19 |
% |
General and administrative |
|
|
15,409 |
|
|
|
14,490 |
|
|
|
919 |
|
|
|
6 |
% |
Total operating expenses |
|
|
97,633 |
|
|
|
62,991 |
|
|
|
34,642 |
|
|
|
55 |
% |
Loss from operations |
|
|
(96,877 |
) |
|
|
(62,025 |
) |
|
|
(34,852 |
) |
|
|
56 |
% |
Other income (expense): |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Interest and other income, net |
|
|
1,265 |
|
|
|
2,293 |
|
|
|
(1,028 |
) |
|
|
-45 |
% |
Total other income, net |
|
|
1,265 |
|
|
|
2,293 |
|
|
|
(1,028 |
) |
|
|
-45 |
% |
Net loss |
|
$ |
(95,612 |
) |
|
$ |
(59,732 |
) |
|
$ |
(35,880 |
) |
|
|
60 |
% |
Net loss per share - basic and diluted |
|
$ |
(1.07 |
) |
|
$ |
(0.85 |
) |
|
$ |
(0.22 |
) |
|
|
26 |
% |
Weighted average shares outstanding - basic and diluted |
|
|
89,245 |
|
|
|
70,168 |
|
|
|
19,077 |
|
|
|
27 |
% |
Product Sales, Net
Product sales, net remained consistent for the three months ended September 30, 2026 compared to the same period the prior year.
License and Collaboration Agreement
License and collaboration agreement revenue decreased by $0.1 million, or 67% to less than $0.1 million for the three months ended September 30, 2026. 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 remained consistent for the three months ended September 30, 2026 compared to the same period the prior year.
Cost of Sales
Cost of sales decreased by $0.2 million or 27% to $0.5 million for the three months ended September 30, 2026 compared to the same period the prior year. This decrease was primarily attributable to lower commercial product sales year over year.
24
Research and Development
The following table summarizes our research and development expenses for the three months ended September 30, 2026 and 2025:
|
|
Three Months Ended |
|
|
|||||
|
|
September 30, |
|
|
|||||
|
|
2026 |
|
|
2025 |
|
|
||
Direct research and development expenses by program: |
|
|
|
|
|
|
|
||
DURAVYU |
|
$ |
55,257 |
|
|
$ |
29,631 |
|
|
Other direct research and development |
|
|
89 |
|
|
|
537 |
|
|
Unallocated expenses: |
|
|
|
|
|
|
|
||
Personnel (including stock based compensation) |
|
|
21,373 |
|
|
|
13,794 |
|
|
Facilities |
|
|
1,177 |
|
|
|
1,134 |
|
|
Other |
|
|
3,774 |
|
|
|
2,658 |
|
|
Total research and development expenses |
|
|
81,670 |
|
|
|
47,754 |
|
|
Research and development expenses increased by $33.9 million, or 71%, to $81.7 million for the three months ended September 30, 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. We expect a decrease in research and development expenses in 2027 in connection with the Prioritization.
Sales and Marketing
Sales and marketing expenses remained consistent and immaterial for the three months ended September 30, 2026 compared to the same period the prior year.
General and Administrative
General and administrative expenses increased by $0.9 million, or 6%, to $15.4 million for the three months ended September 30, 2026 compared to the same period the prior year. This increase was primarily attributable to increased personnel costs, including non-cash stock compensation. We expect a decrease in general and administrative expenses in 2027 in connection with the Prioritization.
Interest (Expense) Income
Interest (expense) income decreased by $1.0 million or 45% to $1.3 million for the three months ended September 30, 2026 compared to the same period the prior year. This decrease was primarily driven by lower cash available for investment in marketable securities.
25
Nine Months Ended September 30, 2026 Compared to Nine Months Ended September 30, 2025 (In thousands except share data and percentages:
|
|
Nine Months Ended |
|
|
|
|
||||||||||
|
|
September 30, |
|
|
Change |
|
||||||||||
|
|
2026 |
|
|
2025 |
|
|
Amounts |
|
|
% |
|
||||
Revenues: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Product sales, net |
|
$ |
995 |
|
|
$ |
1,297 |
|
|
$ |
(302 |
) |
|
|
-23 |
% |
License and collaboration agreements |
|
|
695 |
|
|
|
16,531 |
|
|
|
(15,836 |
) |
|
|
-96 |
% |
Royalty income |
|
|
269 |
|
|
|
12,923 |
|
|
|
(12,654 |
) |
|
|
-98 |
% |
Total revenues |
|
|
1,959 |
|
|
|
30,751 |
|
|
|
(28,792 |
) |
|
|
-94 |
% |
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Cost of sales |
|
|
1,056 |
|
|
|
1,691 |
|
|
|
(635 |
) |
|
|
-38 |
% |
Research and development |
|
|
237,427 |
|
|
|
161,825 |
|
|
|
75,602 |
|
|
|
47 |
% |
Sales and marketing |
|
|
65 |
|
|
|
96 |
|
|
|
(31 |
) |
|
|
-32 |
% |
General and administrative |
|
|
44,894 |
|
|
|
40,228 |
|
|
|
4,666 |
|
|
|
12 |
% |
Total operating expenses |
|
|
283,442 |
|
|
|
203,840 |
|
|
|
79,602 |
|
|
|
39 |
% |
Loss from operations |
|
|
(281,483 |
) |
|
|
(173,089 |
) |
|
|
(108,394 |
) |
|
|
63 |
% |
Other income (expense): |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Interest and other income, net |
|
|
6,519 |
|
|
|
8,829 |
|
|
|
(2,310 |
) |
|
|
-26 |
% |
Total other income, net |
|
|
6,519 |
|
|
|
8,829 |
|
|
|
(2,310 |
) |
|
|
-26 |
% |
Net loss before income taxes |
|
$ |
(274,964 |
) |
|
$ |
(164,260 |
) |
|
$ |
(110,704 |
) |
|
|
67 |
% |
Provision for income taxes |
|
$ |
50 |
|
|
$ |
(93 |
) |
|
$ |
143 |
|
|
|
-154 |
% |
Net loss |
|
$ |
(274,914 |
) |
|
$ |
(164,353 |
) |
|
$ |
(110,561 |
) |
|
|
67 |
% |
Net loss per share - basic and diluted |
|
$ |
(3.15 |
) |
|
$ |
(2.35 |
) |
|
$ |
(0.80 |
) |
|
|
34 |
% |
Weighted average shares outstanding - basic and diluted |
|
|
87,274 |
|
|
|
69,955 |
|
|
|
17,319 |
|
|
|
25 |
% |
Product Sales, Net
Product sales, net decreased by $0.3 million, or 23%, to $1.0 million for the nine months ended September 30, 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 $15.8 million, or 96%, to $0.7 million for the nine months ended September 30, 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 $12.7 million, or 98%, to $0.3 million for the nine months ended September 30, 2026 compared to the same period the prior year. This decrease was primarily due to the termination of the SWK royalty purchase agreement (RPA) on March 18, 2025.
Cost of Sales
Cost of sales decreased by $0.6 million, or 38%, to $1.1 million for the nine months ended September 30, 2026 compared to the same period the prior year. This decrease was primarily attributable to lower commercial product sales year over year.
26
Research and Development
The following table summarizes our research and development expenses for the nine months ended September 30, 2026 and 2025:
|
|
Nine Months Ended |
|
|||||
|
|
September 30, |
|
|||||
|
|
2026 |
|
|
2025 |
|
||
Direct research and development expenses by program: |
|
|
|
|
|
|
||
DURAVYU |
|
$ |
160,094 |
|
|
$ |
108,878 |
|
Other direct research and development |
|
|
598 |
|
|
|
2,525 |
|
Unallocated expenses: |
|
|
|
|
|
|
||
Personnel (including stock based compensation) |
|
|
62,630 |
|
|
|
38,883 |
|
Facilities |
|
|
3,228 |
|
|
|
3,332 |
|
Other |
|
|
10,877 |
|
|
|
8,207 |
|
Total research and development expenses |
|
|
237,427 |
|
|
|
161,825 |
|
Research and development expenses increased by $75.6 million, or 47%, to $237.4 million for the nine months ended September 30, 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. We expect a decrease in research and development expenses in 2027 in connection with the Prioritization.
Sales and Marketing
Sales and marketing expenses remained consistent and immaterial for the nine months ended September 30, 2026 compared to the same period the prior year.
General and Administrative
General and administrative expenses increased by $4.7 million, or 12%, to $44.9 million for the nine months ended September 30, 2026 compared to the same period the prior year. This increase was primarily attributable to increased personnel costs, including non-cash stock compensation. We expect a decrease in general and administrative expenses in 2027 in connection with the Prioritization.
Interest (Expense) Income
Interest (expense) income decreased by $2.3 million, or 26%, to $6.5 million for the nine months ended September 30, 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 September 30, 2026 we had a total accumulated deficit of $1,379.9 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 September 30, 2026, we sold 3,049,942 shares of common stock under the ATM Facility at a weighted average price of $8.49 per share for gross proceeds of approximately $25.9 million. Share issue costs, including sales agent commissions, totaled approximately $0.8 million.
During the nine months ended September 30, 2026, we sold 4,478,989 shares of common stock under the ATM Facility at a weighted average price of $10.30 per share for gross proceeds of approximately $46.1 million. Share issue costs, including sales agent
27
commissions, totaled approximately $1.5 million. Subsequent to September 30, 2026, we sold 22,992,900 shares of common stock under the ATM Facility at a weighted average price of $0.44 per share for gross proceeds of approximately $10.1 million. Share issue costs, including sales agent commissions, totaled approximately $0.3 million.
During the three and nine months ended September 30, 2025 we sold 495,118 shares of our common stock under the ATM facility at a weighted average price of $14.01 per share for gross proceeds of approximately $6.9 million. Share issue costs, including sales agent commissions, totaled $0.3 million.
Future Funding Requirements
At September 30, 2026, we had cash, cash equivalents, and investments in marketable securities of $118.2 million. We expect that our cash, cash equivalents, and investments in marketable securities, coupled with the additional $10.1 million raised pursuant to the ATM Facility subsequent to September 30, 2026, and with anticipated operational adjustments, will enable us to fund operations into late Q3 2027. We continue to pursue business development, financing and other cost reduction opportunities that could further extend this cash runway. Beyond that point, we will need to raise additional capital to finance our operations, which cannot be assured. 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, 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, compliance, 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 the timing and results of our clinical trials for DURAVYU, the impact of the Company’s strategic prioritization plan and accompanying reduction in force, and competing technological and market developments. These conditions and events raise substantial doubt about the Company’s ability to continue as a going concern.
The amount of additional capital we will require will be influenced by many factors, including, but not limited to:
We plan to seek additional funding through a combination of equity offerings, government or private-party grants, debt financings, or other capital sources, such as collaborations with other companies, strategic alliances, or licensing arrangements. We may not be able to obtain financing on acceptable terms, or at all, or enter into collaborative arrangements. Although management will continue to pursue these plans, there is no assurance that they will be successful or provide sufficient funding when needed. If we are unable to obtain funding, we could be forced to delay, reduce, or eliminate some or all of our research and development programs, including our clinical trials, pipeline expansion, or commercialization efforts, which could adversely affect our business prospects. Accordingly, management’s plans do not alleviate substantial doubt about our ability to continue as a going concern.
28
Our condensed consolidated statements of historical cash flows are summarized as follows (in thousands):
|
|
|
|
|
|
|
||||||
|
|
Nine Months Ended |
|
|
|
|
||||||
|
|
September 30, |
|
|
|
|
||||||
|
|
2026 |
|
|
2025 |
|
|
Change |
|
|||
Cash flows from operating activities: |
|
|
|
|
|
|
|
|
|
|||
Net loss |
|
$ |
(274,914 |
) |
|
$ |
(164,353 |
) |
|
$ |
(110,561 |
) |
Changes in operating assets and liabilities |
|
|
11,450 |
|
|
|
(29,470 |
) |
|
|
40,920 |
|
Other adjustments to reconcile net loss to cash flows from |
|
|
33,751 |
|
|
|
18,760 |
|
|
|
14,991 |
|
Net cash (used in) provided by operating activities |
|
$ |
(229,713 |
) |
|
$ |
(175,063 |
) |
|
$ |
(54,650 |
) |
Net cash (used in) provided by investing activities |
|
$ |
167,950 |
|
|
$ |
143,246 |
|
|
$ |
24,704 |
|
Net cash (used in) provided by financing activities |
|
$ |
43,148 |
|
|
$ |
6,690 |
|
|
$ |
36,458 |
|
Operating cash outflows for the nine months ended September 30, 2026 totaled $229.7 million primarily due to our net loss of $274.9 million reduced by $33.8 million of non-cash expenses, which was primarily attributable to $33.9 million of stock-based compensation. We incurred cash inflows of $11.5 million in other working capital adjustments driven primarily by increased prepaid clinical expenses.
Operating cash outflows for the nine months ended September 30, 2025 totaled $175.1 million primarily due to our net loss of $164.4 million reduced by $18.8 million of non-cash expenses, which included $21.1 million of stock-based compensation, partially offset by $3.9 million for amortization of discount on available for sale of marketable securities. We incurred cash outflows related to changes in working capital of $29.5 million, which included $28.6 million of deferred revenue related to the agreement to license YUTIQ® product rights to ANI offset by $0.8 million in other working capital adjustments.
For the nine months ended September 30, 2026, $171.4 million of net cash was provided by investing activities from the sales of marketable securities and gain on equity investments, offset by $3.4 million used for the purchase of property and equipment.
For the nine months ended September 30, 2025, $145.5 million of net cash was provided by investing activities from the sales of marketable securities, offset by $2.3 million used for the purchase of property and equipment.
Net cash provided by financing activities for the nine months ended September 30, 2026 totaled $43.1 million and consisted mainly of the following:
Net cash provided by financing activities for the nine months ended September 30, 2025 totaled $6.7 million and consisted mainly of the following:
29
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 September 30, 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 September 30, 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 September 30, 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.
30
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 alleged, 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 asserted 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 were 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 deemed 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 deemed 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 continued on July 7, 2026. On October 30, 2026, we reached an agreement with Ocular to end the litigation and filed a joint stipulation of dismissal with prejudice.
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 OUR FINANCING POSITION AND OUR CAPITAL RESOURCES
There is uncertainty regarding our ability to raise additional capital and there is substantial doubt regarding our ability to continue as a going concern.
Our unaudited financial statements have been prepared under the assumption that we will continue as a going concern. However, we have concluded that there is substantial doubt about our ability to continue as a going concern, because without additional sources of funding, our cash and cash equivalents and short-term investments at September 30, 2026 are not sufficient for us to fund our operating expenses and capital expenditures for at least the 12 months after the date that the unaudited financial statements included in this Quarterly Report on Form 10-Q are issued. Management’s plans concerning these matters, including raising additional capital, are described in “Part I - Item 2 – Management’s Discussion and Analysis of Financial Condition and Results of Operation - Liquidity and Capital Resources – Future Funding Requirements.” We continue to evaluate options to further finance our operating cash needs through a combination of some, or all, of the following: equity and debt offerings, loan agreements, collaborations, strategic alliances and/or other transactions. Any additional fundraising efforts may divert our management from their day-to-day activities, which may compromise our ability to develop and commercialize our product candidate. If we issue additional securities to raise funds, these securities may have rights, preferences, or privileges senior to those of our common stock, our current stockholders may experience dilution and the market price of our common stock may decline. There can be no assurance that additional financing will be available when needed or that management will be able to obtain financing on terms acceptable to us. If
31
we are unable to obtain funding when required in the future, we could be required to delay, reduce or eliminate research and development programs, program portfolio expansions or future commercialization efforts, or even curtail or cease operations. See also risk factors included in our Annual Report on 10-K under the header “1A- Risk Factors - Risks Related To Our Financial Position And Our Capital Resources.”
Our strategic prioritization plan to focus on the Company’s late-stage program for DURAVYU in DME and accompanying workforce reduction may not achieve our intended outcome.
On October 19, 2026, we announced a strategic prioritization plan (the “Prioritization”) designed to reduce operating expenses and focus resources on the Company’s late-stage program for DURAVYU™ in DME. The Prioritization includes a plan to conclude the pivotal Phase 3 wet AMD clinical trials early and reduce the Company’s workforce by approximately 53%, with the substantial majority of the workforce reduction expected to occur during the fourth quarter of 2026 and to be completed during the first half of 2027. As a result of the Prioritization, the Company estimates it will incur aggregate charges of approximately $9.0 million related to employee separation benefits, including employee severance and other related expenses, a majority of which are expected to be recognized during the fourth quarter of 2026 with the remaining charges recognized through the third quarter of 2027. The Company expects that substantially all of these charges will result in cash expenditures over the same time period
The reduction in force may result in unintended consequences and costs, such as the loss of institutional knowledge and expertise, attrition beyond the intended number of employees, decreased morale among our remaining employees, and the risk that we may not achieve the anticipated benefits of the reduction in force. In addition, while positions have been eliminated, certain functions necessary to our operations remain, and we may be unsuccessful in distributing the duties and obligations of departed employees among our remaining employees. The reduction in workforce could also make it difficult for us to pursue, or prevent us from pursuing, new opportunities and initiatives due to insufficient personnel, or require us to incur additional and unanticipated costs to hire new personnel to pursue such opportunities or initiatives. The workforce reduction could also harm our reputation, making our ability to recruit skilled personnel difficult. If we are unable to realize the anticipated benefits from the reduction in force, or if we experience significant adverse consequences from the reduction in force, our business, financial condition, and results of operations may be materially adversely affected.
In addition, under the Prioritization, we intend to focus on the Company’s late-stage program for DURAVYU™ in DME. If we are not successful in increasing our efficiency as a result of the Prioritization, our efforts to develop and commercialize our product candidate may be delayed or halted and our business could be materially adversely impacted.
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. For example, following our recent announcement of LUGANO and LUCIA clinical trial results in August 2026 and October 2026, respectively, the trading price of our common stock declined significantly. The trading price of our common stock may experience similarly significant declines in the future in response to clinical trial results, including results that may be viewed by us as positive or that may otherwise meet specified clinical endpoints, if such results do not meet the expectations of investors, securities analysts or other market participants. 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:
32
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.
If we are unable to maintain listing of our securities on Nasdaq or another reputable stock exchange, it may be more difficult for our stockholders to sell their securities.
Nasdaq requires listing issuers to comply with certain standards in order to remain listed on its exchange. If, for any reason, Nasdaq should delist our securities from trading on its exchange and we are unable to obtain listing on another reputable national securities exchange, a reduction in some or all of the following may occur, each of which could materially adversely affect our stockholders. For example, if at any time the bid price of our common stock closes at below $1.00 per share for more than 30 consecutive trading days, we may be subject to delisting from the Nasdaq Global Market. If we receive a delisting notice, we would have 180 calendar days to regain compliance (subject to any additional 180-day compliance period which may be available to us), which would mean having a bid price above the minimum of $1.00 for at least 10 consecutive days in the 180-day period. During this 180-day period, we would anticipate reviewing our options to regain compliance with the minimum bid requirements. To the extent that we are unable to resolve any listing deficiency, there is a risk that our common stock may be delisted from Nasdaq, which would adversely impact liquidity of our common stock and potentially result in even lower bid prices for our common stock. On November 10, 2026, the closing price of our common stock was $0.4041 per share, and the last time the bid price of our common stock closed at or above $1.00 per share was October 16, 2026.
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)
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 September 30, 2026, our executive officers and directors adopted, modified or terminated Rule 10b5-1 trading arrangements for the purchase or sale of our common stock as noted below:
33
Name and Title of Director or Officer |
Action |
Date of Adoption or Termination |
Aggregate Number of Shares of Common Stock that may be Sold under the Plan |
Up to |
|||
Up to |
(1)
34
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 |
|
|
|
|
|
|
|
|
|
10.1# |
|
Settlement Agreement, dated July 17, 2026, by and among the United States of America, acting through the United States Department of Justice and on behalf of the Office of Inspector General of the Department of Health and Human Services and the Defense Health Agency, acting on behalf of the TRICARE Program, EyePoint, Inc., and the relator named therein, through their authorized representatives. |
|
8-K |
|
07/17/26 |
|
10.1 |
|
|
|
|
|
|
|
|
|
10.2# |
|
Corporate Integrity Agreement, dated July 13, 2026, by and among the Office of Inspector General of the Department of Health and Human Services and EyePoint, Inc |
|
8-K |
|
07/17/26 |
|
10.2 |
|
|
|
|
|
|
|
|
|
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 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
35
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.
* Filed herewith
** Furnished herewith
36
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: November 12, 2026 |
By: |
/s/ Jay S. Duker |
|
Name: |
Jay S. Duker, M.D. |
|
Title: |
President and Chief Executive Officer (Principal Executive Officer) |
|
|
|
Date: November 12, 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) |
37