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☒
QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the quarterly period ended
September 30,
2025
OR
☐
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
Commission File Number:
001-37783
Clearside Biomedical, Inc.
(Exact Name of Registrant as Specified in its Charter)
Delaware
45-2437375
(State or other jurisdiction of
incorporation or organization)
(I.R.S. Employer
Identification No.)
900 North Point Parkway
,
Suite 200
Alpharetta
,
GA
30005
(Address of principal executive offices)
(Zip Code)
(
678
)
270-3631
Registrant’s telephone number, including area code
N/A
(Former name, former address and former fiscal year, if changed since last report)
Securities registered pursuant to Section 12(b) of the Act:
Title of each class
Trading Symbol(s)
Name of each exchange on which registered
Common Stock, par value $0.001 per share
CLSD
The Nasdaq Stock Market LLC
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.
Yes
☒ No ☐
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).
Yes
☒ No ☐
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
☐
Non-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
☒
As of November 12, 2025, the registrant had
5,233,981
shares of common stock,
$0.001 par value per share, outstanding.
Accounts payable (includes $
491
to a related party as of
December 31, 2024)
$
796
$
1,452
Accrued liabilities (includes $
304
to a related party as of
December 31, 2024)
1,590
2,967
Current portion of operating lease liabilities
384
375
Total current liabilities
2,770
4,794
Liability related to the sales of future royalties, net
61,167
51,767
Warrant liabilities
1,192
6,692
Operating lease liabilities
62
328
Other non-current liabilities
400
400
Total liabilities
65,591
63,981
Commitments and contingencies
Stockholders’ deficit:
Preferred stock, $
0.001
par value;
10,000,000
shares authorized and
no
shares issued at September 30, 2025 and December 31, 2024
—
—
Common stock, $
0.001
par value;
26,666,666
and
13,333,333
shares authorized at
September 30, 2025 and December 31, 2024, respectively;
5,233,981
and
5,105,216
shares issued and outstanding at September 30, 2025 and December 31, 2024,
respectively
(1)
78
77
Additional paid-in capital
319,937
316,343
Accumulated deficit
(
373,965
)
(
355,275
)
Total stockholders’ deficit
(
53,950
)
(
38,855
)
Total liabilities and stockholders’ deficit
$
11,641
$
25,126
(1)
Results, including shares issued and outstanding have been adjusted to reflect the one-for-fifteen reverse stock split effected in September 2025. See Note 1, The Company, for details
.
See accompanying notes to the consolidated financial statements.
3
CLEARSIDE BIOMEDICAL, INC.
Consolidated State
ments of Operations
(in thousands, except share and per share data)
(unaudited)
Three Months Ended
September 30,
Nine Months Ended
September 30,
2025
2024
2025
2024
License and other revenue (includes $
172
and $
81
from a related party for the three months ended
September 30, 2025 and 2024, respectively, and $
494
and $
237
for the nine months ended September 30,
2025 and 2024, respectively)
$
201
$
1,038
$
3,023
$
1,358
Operating expenses:
Cost of goods sold
—
—
248
—
Research and development (includes $
255
and $
473
to a
related party for the three and nine months ended
September 30, 2024, respectively)
2,933
4,128
8,980
14,346
General and administrative
4,308
2,844
9,608
8,745
Total operating expenses
7,241
6,972
18,836
23,091
Loss from operations
(
7,040
)
(
5,934
)
(
15,813
)
(
21,733
)
Interest income
65
338
343
1,104
Other income, net
3,573
365
5,500
783
Non-cash interest expense on liability
related to the sales of future royalties
(
2,570
)
(
2,457
)
(
8,005
)
(
7,200
)
Loss before income taxes
(
5,972
)
(
7,688
)
(
17,975
)
(
27,046
)
Income tax expense
—
—
715
—
Net loss
$
(
5,972
)
$
(
7,688
)
$
(
18,690
)
$
(
27,046
)
Net loss per share of common stock — basic and diluted
(1)
$
(
1.14
)
$
(
1.54
)
$
(
3.61
)
$
(
5.55
)
Weighted average shares outstanding — basic and diluted
(1)
5,233,981
4,983,032
5,184,275
4,874,398
Net loss
$
(
5,972
)
$
(
7,688
)
$
(
18,690
)
$
(
27,046
)
Unrealized gain on available-for-sale investments
—
6
—
5
Comprehensive loss
$
(
5,972
)
$
(
7,682
)
$
(
18,690
)
$
(
27,041
)
(1) Results, including shares issued and outstanding have been adjusted to reflect the one-for-fifteen reverse stock split effected in September 2025. See Note 1, The Company, for details.
See accompanying notes to the consolidated financial statements.
4
CLEARSIDE BIOMEDICAL, INC.
Consolidated State
ments of Stockholders’ Deficit
(in thousands, except share data)
(unaudited)
Nine Months Ended September 30, 2025
Total
Common Stock
Additional
Accumulated
Stockholders'
Shares
Amount
Paid-In-Capital
Deficit
Deficit
Balance at December 31, 2024
5,105,216
$
77
$
316,343
$
(
355,275
)
$
(
38,855
)
Issuance of common stock under at-the-market
sales agreement
28,447
—
434
—
434
Vesting and settlement of restricted stock units
16,757
—
—
—
—
Issuance of common stock under employee stock
purchase plan
1,081
—
13
—
13
Share-based compensation expense
—
—
721
—
721
Net loss
—
—
—
(
8,223
)
(
8,223
)
Balance at March 31, 2025
5,151,501
77
317,511
(
363,498
)
(
45,910
)
Issuance of common stock under at-the-market
sales agreement
81,510
1
976
—
977
Share-based compensation expense
—
—
694
—
694
Net loss
—
—
—
(
4,495
)
(
4,495
)
Balance at June 30, 2025
5,233,011
78
319,181
(
367,993
)
(
48,734
)
Issuance of common stock under employee stock
purchase plan
970
—
10
—
10
Share-based compensation expense
—
—
746
—
746
Net loss
—
—
—
(
5,972
)
(
5,972
)
Balance at September 30, 2025
5,233,981
$
78
$
319,937
$
(
373,965
)
$
(
53,950
)
Nine Months Ended September 30, 2024
Accumulated
Other
Total
Common Stock
Additional
Accumulated
Comprehensive
Stockholders'
Shares
(1)
Amount
Paid-In-Capital
Deficit
Loss
Deficit
Balance at December 31, 2023
4,190,069
$
63
$
304,948
$
(
320,923
)
$
—
$
(
15,912
)
Issuance of common stock under registered direct
offering
740,740
11
4,309
—
—
4,320
Issuance of common stock under at-the-market
sales agreement
22,656
—
450
—
—
450
Exercise of stock options
666
—
12
—
—
12
Vesting and settlement of restricted stock units
26,505
—
—
—
—
—
Issuance of common stock under employee
stock purchase plan
1,445
—
21
—
—
21
Share-based compensation expense
—
—
1,062
—
—
1,062
Net loss
—
—
—
(
11,763
)
—
(
11,763
)
Balance at March 31, 2024
4,982,081
74
310,802
(
332,686
)
—
(
21,810
)
Share-based compensation expense
—
—
1,120
—
—
1,120
Net loss
—
—
—
(
7,595
)
—
(
7,595
)
Other comprehensive loss
—
—
—
—
(
1
)
(
1
)
Balance at June 30, 2024
4,982,081
74
311,922
(
340,281
)
(
1
)
(
28,286
)
Issuance of common stock under the employee
stock purchase plan
962
1
13
—
—
14
Share-based compensation expense
—
—
1,165
—
—
1,165
Net loss
—
—
—
(
7,688
)
—
(
7,688
)
Other comprehensive gain
—
—
—
—
6
6
Balance at September 30, 2024
4,983,043
$
75
$
313,100
$
(
347,969
)
$
5
$
(
34,789
)
(1)
Results, including shares issued and outstanding have been adjusted to reflect the one-for-fifteen reverse stock split effected in September 2025. See Note 1, The Company, for details
.
See accompanying notes to the consolidated financial statements.
5
CLEARSIDE BIOMEDICAL, INC.
C
onsolidated Statements of Cash Flows
(in thousands)
(unaudited)
Nine Months Ended
September 30,
2025
2024
Operating activities
Net loss
$
(
18,690
)
$
(
27,046
)
Adjustments to reconcile net loss to net cash used in operating activities:
Non-cash interest expense on liability related to the sales of
future royalties, net of issuance costs accretion
8,005
7,200
Depreciation
253
147
Share-based compensation expense
2,161
3,347
Change in fair value of warrant liabilities
(
5,500
)
(
1,570
)
Issuance costs allocated to warrant liabilities
—
787
Amortization and accretion of available-for-sales investments, net
—
(
286
)
Changes in operating assets and liabilities:
Prepaid expenses and other current assets
(
199
)
(
319
)
Other assets and liabilities
(
36
)
(
506
)
Accounts payable and accrued liabilities (includes $
223
to a related party
for the nine months ended September 30, 2024)
(
2,033
)
(
1,123
)
Deferred revenue
—
(
75
)
Net cash used in operating activities
(
16,039
)
(
19,444
)
Investing activities
Acquisition of property and equipment
(
9
)
(
533
)
Purchase of short-term investments
—
(
16,912
)
Maturity of short-term investments
—
7,500
Net cash used in investing activities
(
9
)
(
9,945
)
Financing activities
Proceeds from issuance of common stock and warrants under
registered direct offering, net of issuance costs
—
13,860
Proceeds from at-the-market sales agreement, net of issuance costs
1,411
450
Proceeds from royalty purchase and sale agreement, net of issuance costs
2,895
—
Payments on royalty purchase and sale agreement
(
1,500
)
—
Proceeds from exercise of stock options
—
12
Proceeds from shares issued under employee stock purchase plan
23
35
Net cash provided by financing activities
2,829
14,357
Net decrease in cash and cash equivalents
(
13,219
)
(
15,032
)
Cash and cash equivalents, beginning of period
20,020
28,920
Cash and cash equivalent, end of period
$
6,801
$
13,888
Supplemental disclosure
Purchase of property and equipment included in accrued liabilities
$
—
$
31
See accompanying notes to the consolidated financial statements.
6
CLEARSIDE BIOMEDICAL, INC.
N
otes to the Consolidated Financial Statements
(unaudited)
1. The Company
Clearside Biomedical, Inc. (the “Company”) is a biopharmaceutical company focused on revolutionizing the delivery of therapies to the back of the eye through the suprachoroidal space (SCS
®
). Incorporated in the State of Delaware on
May 26, 2011
, the Company has its corporate headquarters in Alpharetta, Georgia.
The Company’s activities since inception have primarily consisted of developing product and technology rights, raising capital and performing research and development activities. The Company is subject to a number of risks and uncertainties similar to those of other life science companies at a similar stage of development, including, among others, the need to obtain adequate additional financing, successful development efforts including regulatory approval of products, compliance with government regulations, successful commercialization of potential products, protection of proprietary technology and dependence on key individuals.
Reverse Stock Split
On August 29, 2025, the Company held a special meeting of stockholders at which its stockholders approved a proposal to effect an amendment to the Company’s Amended and Restated Certificate of Incorporation to implement a reverse stock split and a corresponding reduction in the total number of authorized shares of the Company’s common stock. On September 4, 2025, the Company’s board of directors approved the filing of a certificate of amendment to the Company’s Restated Certificate of Incorporation with the Secretary of State of the State of Delaware to affect the one-for-fifteen (1:15) reverse stock split of its outstanding common stock and a corresponding reduction in the total number of authorized shares of the Company’s common stock (the “Reverse Stock Split”).
On September 12, 2025, the Company effected the Reverse Stock Split. Pursuant to their terms, a proportionate adjustment was made to the per share exercise price and number of shares issuable under all of the Company’s outstanding options and warrants, and the number of shares authorized for issuance pursuant to the Company’s equity incentive plans have been reduced proportionately.
No fractional shares were issued as a result of the Reverse Stock Split. Stockholders of record who would have otherwise been entitled to receive a fractional share received a cash payment in lieu thereof. The Reverse Stock Split affected all stockholders proportionately and did not affect any stockholder’s percentage ownership of the Company’s common stock (except to the extent that the Reverse Stock Split resulted in any stockholder owning only a fractional share).
Liquidity
The Company had cash and cash equivalents of
$
6.8
million
as of September 30, 2025. In July 2025, the Company announced plans to explore a full range of strategic alternatives to advance its SCS platform and drug development pipeline to maximize stockholder value. The Company has retained Piper Sandler, a leading investment bank with substantial experience in the biotechnology industry, to support it with the strategic evaluation process. Strategic alternatives under consideration include the sale, license, monetization and/or divestiture of one or more of the Company’s assets and technologies, collaboration, partnership, merger, acquisition, joint ventures, or other strategic transactions. If a strategic alternative is not available, the Company will be required to take additional actions to fund the Company’s operations, or it may be forced to file for bankruptcy or wind down its operations. In addition, in July 2025, the Company implemented a plan pursuant to which all of the Company’s employees had their employment with the Company terminated and transitioned into consulting roles with the Company (the "Reduction in Force"). The Company incurred charges of
$
2.3
million for
severance and other employee termination related
costs during the three months ended September 30, 2025 of which $
1.2
million was recorded in research and development expenses and $
1.1
million was
recorded in general and administrative expenses. The Company expects to incur approximately $
0.1
million in additional costs for other employee termination related costs. As part of the strategic alternative process, the Company has paused all internal research and development programs
which can be resumed if the Company is able to raise additional capital.
Historically, the Company has funded its operations primarily through the sale of common stock and convertible preferred stock, the issuance of warrants, the issuance of long-term debt, and license agreements.
On September 4, 2025, the Company entered into an Omnibus Amendment Agreement (the “Amendment”) with Royalty Sub (as defined below) and with entities managed by HCR (as defined below). Pursuant to the Amendment, Royalty Sub received an additional payment of $
2.9
million, representing $
3.0
million to which the Royalty Sub was entitled, less $
0.1
million of transaction expenses, from HCR, which Royalty Sub then paid to the Company in exchange for the remaining assets related to the Company's SCS Microinjector technology. See Note 5 for further details.
On
February 6, 2024, the Company entered into a securities purchase agreement with institutional investors and an existing stockholder, pursuant to which the Company issued and sold, in a registered direct offering (the “Registered Direct Offering”): (i) an
7
aggregate
of
740,740
shares of its common stock; and (ii) warrants to purchase up to
740,740
shares of common stock (the “Warrants”). The combined purchase price of each share and accompanying Warrant was $
20.25
. The exercise price for the Warrants is $
24.30
per share. The Warrants are currently exercisable and will expire on
August 9, 2029
.
The net proceeds to the Company from the Registered Direct Offering were $
13.9
million.
On January 31, 2024 (the “Amendment Effective Date”), the Company entered into a fourth amendment to the license agreement (as amended, the “Emory License Agreement”) with Emory University and Georgia Tech Research Corporation (collectively, the “Licensor”) pursuant to which the parties agreed to reduce the Sublicense Percentage (as defined in the Emory License Agreement) from a low double digit percentage to a high single digit percentage that the Company will pay the Licensor applicable to any fees or payments paid to the Company by any Sublicensee (as defined in the Emory License Agreement) of the Licensed Patents and/or Licensed Technology (each as defined in the Emory License Agreement), excluding (i) amounts paid to the Company by a Sublicensee to reimburse the Company for certain research and development costs pursuant to a written agreement between the Company and such Sublicensee, (ii) the value of intellectual property transferred or granted to the Company if necessary or helpful to the development or commercialization of Licensed Products (as defined in the Emory License Agreement) and (iii) amounts paid for shares of the Company’s stock. The payment to Licensor of any such Sublicense Percentage is due within 30 days of receipt by the Company of a qualifying payment from a Sublicensee, provided however, with respect to any qualifying payments received by the Company from a Sublicensee after July 1, 2023 but prior to January 1, 2025, the payment to Licensor of any such Sublicensee Percentage was due to Licensor by March 31, 2025. The parties also agreed to a revised annual license maintenance fee due each year (the “Maintenance Fee”) starting in 2023 through 2028, as follows: $
0.3
million for 2023 through 2025, $
0.4
million for 2026 and for 2027 and $
0.5
million for 2028. The annual Maintenance Fee payments are due on October 1st of each year.
In May 2023, the Company entered into a Controlled Equity Offering
SM
Sales Agreement (the "Sales Agreement") with Cantor Fitzgerald & Co. ("Cantor") under which the Company may offer and sell, from time to time at its sole discretion, shares of its common stock, having an aggregate offering price of up to $
50.0
million through Cantor as its sales agent. During the nine months ended September 30, 2025, the Company sold
109,957
shares of its common stock for net proceeds of $
1.4
million under the Sales Agreement. During the nine months ended September 30, 2024, the Company sold
22,656
shares of its common stock under the Sales Agreement for net proceeds of $
0.5
million.
The Company has suffered recurring losses and negative cash flows from operations since inception and anticipates incurring additional losses until such time, if ever, that it can generate significant revenue. The Company has no current source of revenue to sustain present activities. The Company does not expect to generate other meaningful revenue until and unless the Company's licensees successfully commercialize XIPERE and the Company has fulfilled its obligations under the Purchase and Sale Agreement (as defined below), its other licensees receive regulatory approval and successfully commercialize its product candidates, or the Company commercializes its product candidates either on its own or with a third party. In the absence of product or other revenues, the amount, timing, nature or source of which cannot be predicted, the Company’s losses will continue as it conducts its research and development activities.
The Company will continue to need to obtain additional financing to fund future operations, including completing the development, partnering and potential commercialization of its primary product candidates. The Company will need to obtain financing to complete the development and conduct clinical trials for the regulatory approval of its product candidates if requested by regulatory bodies. If such product candidates were to receive regulatory approval, the Company would need to obtain financing to prepare for the potential commercialization of its product candidates, if the Company decides to commercialize the products on its own.
These conditions raise substantial doubt about the Company’s ability to continue as a going concern within one year after the date the consolidated financial statements are issued. Based on its current plans and forecasted expenses, the Company does not expect its cash and cash equivalents will enable the Company to fund its planned operating expenses for the next 12 months from the date of this filing.
Accordingly, the Company’s consolidated financial statements have been prepared on a going concern basis, which contemplates the realization of assets and satisfaction of liabilities in the normal course of business. The consolidated financial statements do not include any adjustments to reflect the possible future effects on the recoverability and classification of recorded asset amounts or the amounts and classification of liabilities that might result should the Company be unable to continue as a going concern.
Until the Company can generate sufficient revenue, the Company will need to finance future cash needs through public or private equity offerings, license agreements, debt financings or restructurings, collaborations, strategic alliances and marketing or distribution arrangements.
8
2. Significant Accounting Policies
Basis of Presentation and Principles of Consolidation
The Company's consolidated financial statements include the results of the financial operations of Clearside Biomedical, Inc. and Royalty Sub, which was formed for the purposes of the transactions contemplated by the Purchase and Sale Agreement described in Note 5. All intercompany balances and transactions have been eliminated.
The Company’s consolidated financial statements have been prepared in conformity with U.S. generally accepted accounting principles (“U.S. GAAP”). In the opinion of management, the Company has made all necessary adjustments, which include normal recurring adjustments necessary for a fair statement of the Company’s consolidated financial position and results of operations for the interim periods presented. The results for the three and nine months ended September 30, 2025 are not indicative of results to be expected for the full year ending December 31, 2025, any other interim periods or any future year or period. These unaudited consolidated financial statements should be read in conjunction with the audited consolidated financial statements and related footnotes, which are included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2024, filed with the Securities and Exchange Commission on March 27, 2025.
During the nine months ended September
30, 2025, the Company recorded an immaterial out of period adjustment of $
641,000
in income tax expense and accrued liabilities related to a foreign jurisdiction.
Use of Estimates
The preparation of consolidated financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the consolidated financial statements and reported amounts of income and expenses during the reporting periods. Significant items subject to such estimates and assumptions include the estimate of the total amount of future royalty revenue and milestone payments to be generated over the life of the Purchase and Sale Agreement described in Note 5, certain assumptions used in the valuation of warrant liabilities, revenue recognition, the accounting for useful lives to calculate depreciation and amortization, clinical trial expense accruals, share-based compensation expense and income tax valuation allowance. Actual results could differ from these estimates.
Revenue Recognition
The Company recognizes revenue from its contracts with customers under Financial Accounting Standards Board ("FASB") Accounting Standards Codification (“ASC”) 606,
Revenue from Contracts with Customers.
The Company’s primary revenue arrangements are license agreements, which typically include upfront payments, regulatory and commercial milestone payments and royalties based on future product sales. The arrangements may also include payments for the Company’s SCS Microinjector devices as well as payments for assistance and oversight of the customer’s use of the Company’s technology. In determining the amount of revenue to be recognized under these agreements, the Company performs the following steps: (i) identifies the promised goods and services to be transferred in the contract, (ii) identifies the performance obligations, (iii) determines the transaction price, (iv) allocates the transaction price to the performance obligations and (v) recognizes revenue as the performance obligations are satisfied.
The Company receives payments from its customers based on billing schedules established in each contract. Upfront and other payments may require deferral of revenue recognition to a future period until the Company performs its obligations under the arrangement. Amounts are recorded as accounts receivable when the Company’s right to consideration is unconditional. The Company does not assess whether a contract has a significant financing component if the expectation at contract inception is such that the period between payment by the customer and the transfer of the promised goods or services to the customer will be one year or less.
Research and Development Costs
Research and development costs are charged to expense as incurred and include:
•
employee-related expenses, including salaries, benefits, travel and share-based compensation expense for research and development personnel;
•
expenses incurred under agreements with contract research organizations, contract manufacturing organizations and consultants that conduct preclinical studies and clinical trials;
•
costs associated with preclinical and clinical development activities;
•
costs associated with submitting regulatory approval applications for the Company’s product candidates;
•
costs associated with training physicians on the suprachoroidal injection procedure and educating and providing them with appropriate product candidate information;
•
costs associated with technology and intellectual property licenses;
•
costs for the Company’s research and development facility; and
9
•
depreciation expense for assets used in research and development activities.
Costs for certain development activities, such as clinical trial activities, are recognized based on an evaluation of the estimated total costs for the clinical trial, progress to completion of specific tasks using data such as participant enrollment, pass-through expenses, clinical site activations, data from the clinical sites or information provided to the Company by its vendors on their actual costs incurred. Payments for these activities are based on the terms of the individual contracts and any subsequent amendments, which may differ from the patterns of costs incurred, and are reflected in the consolidated financial statements as prepaid expenses or accrued liabilities.
Share-Based Compensation
Compensation cost related to share-based awards granted to employees, directors and consultants is measured based on the estimated fair value of the award at the grant date. The Company estimates the fair value of stock options using a Black-Scholes option pricing model. The fair value of restricted stock units granted is measured based on the market value of the Company’s common stock on the date of grant. Share-based compensation costs are expensed on a straight-line basis over the relevant vesting period. The Reduction in Force implemented in July 2025 did not change the vesting terms and conditions of the share-based awards.
Compensation cost related to shares purchased through the Company’s employee stock purchase plan, which is considered compensatory, is based on the estimated fair value of the shares on the offering date, including consideration of the discount and the look-back period. The Company estimates the fair value of the shares using a Black-Scholes option pricing model. Compensation expense is recognized over the six-month withholding period prior to the purchase date.
All share-based compensation costs are recorded in general and administrative or research and development costs in the consolidated statements of operations based upon the recipient's underlying role within the Company.
Cash Equivalents
Cash equivalents consist of short-term, highly liquid investments with an original term of three months or less at the date of purchase.
Concentration of Credit Risk Arising From Cash Deposits in Excess of Insured Limits
The Company maintains its cash in bank deposits that at times may exceed federally insured limits. The Company has not experienced any loss in such accounts. The Company believes it is not exposed to any significant risks with respect to its cash balances.
Liability Related to the Sales of Future Royalties and Non-Cash Interest Expense
In connection with the Purchase and Sale Agreement, the Company recognizes a liability related to the sales of future royalties under ASC 470-10,
Debt
and ASC 835-30,
Interest - Imputation of Interest
. The initial funds received by the Company pursuant to the terms of the Purchase and Sale Agreement were recorded as a liability and are accreted under the effective interest method up to the estimated amount of future royalties and milestone payments to be made under the Purchase and Sale Agreement. The issuance costs were recorded as a direct deduction to the carrying amount of the liability and are being amortized under the effective interest method over the estimated period the liability will be repaid. The Company estimates the total amount of future royalty revenue and milestone payments to be generated over the life of the Purchase and Sale Agreement, and a significant increase or decrease in these estimates could materially impact the liability balance and the related interest expense. If the timing of the receipt of royalty payments or milestones is materially different from the original estimates, the Company will prospectively adjust the effective interest and the related amortization of the liability and related issuance costs.
Warrant Liabilities
The Company accounts for warrants as either equity-classified or liability-classified instruments based on an assessment of the warrant’s specific terms and applicable authoritative guidance in ASC 480,
Distinguishing Liabilities from Equity
("ASC 480") and ASC 815,
Derivatives and Hedging
("ASC 815"). The assessment considers whether the warrants (i) are freestanding financial instruments pursuant to ASC 480, (ii) meet the definition of a liability pursuant to ASC 480, and (iii) meet all of the requirements for equity classification under ASC 815, including whether the warrants are indexed to the Company's own stock and whether the warrant holders could potentially require “net cash settlement” in a circumstance outside of the Company’s control, among other conditions for equity classification. This assessment, which requires the use of professional judgment, is conducted at the time of warrant issuance and as of each subsequent quarterly period end date while the warrants are outstanding.
For warrants that meet all criteria for equity classification, the warrants are required to be recorded as a component of additional paid-in capital, on the consolidated statement of stockholders’ deficit at the time of issuance. For warrants that do not meet all the criteria for equity classification, the warrants are required to be recorded at their initial fair value on the date of issuance and on each consolidated balance sheet date thereafter.
10
The Company’s warrant liabilities are measured at fair value using a simulation model which takes into account, as of the valuation date, factors including the current exercise price, the expected life of the warrant, the current price of the Company's common stock, the expected volatility, the risk-free interest rate for the term of the warrant and the likelihood of achieving certain future milestone events and the related impact to the price of the Company's common stock. The warrant liabilities are revalued at each reporting period and changes in fair value are recognized in other income, net in the consolidated statements of operations. The selection of the appropriate valuation model and the inputs and assumptions that are required to determine the valuation requires significant judgment and requires management to make estimates and assumptions that affect the reported amount of the related liability and reported amounts of the change in fair value. Actual results could differ from those estimates, and changes in these estimates are recorded when known. See Note 7 for further details.
Recently Issued Accounting Pronouncements
In December 2023, the FASB issued Accounting Standards Update ("ASU") 2023-09,
Income Taxes (Topic 740): Improvements to Income Tax Disclosures
. This ASU is intended to enhance the transparency and decision usefulness of income tax disclosures primarily related to the rate reconciliation and income taxes paid information. The main provisions to the rate reconciliation disclosure require public entities to disclose, on an annual basis, specific categories in the rate reconciliation and provide additional information for reconciling items that meet a quantitative threshold. The main provisions to the income taxes paid disclosure require that all entities disclose on an annual basis: the amount of income taxes paid disaggregated by federal, state and foreign taxes and the amount of income taxes paid disaggregated by individual jurisdictions in which income taxes paid meets a quantitative threshold. This ASU also requires all entities to disclose income (loss) from continuing operations before income tax expense (benefit) disaggregated between domestic and foreign and income tax expense (benefit) from continuing operations disaggregated by federal, state and foreign. The Company adopted ASU 2023-09 on January 1, 2025. The adoption did not have a material impact on its consolidated financial statements.
In November 2024, the FASB issued ASU 2024-03,
Income Statement-Reporting Comprehensive Income-Expense Disaggregation Disclosures
. This ASU requires disclosure of disaggregated income statement expense information about specific categories including purchases of inventory, employee compensation expense, depreciation and amortization in the notes to the financial statements. This ASU is effective January 1, 2027 for annual reporting periods and January 1, 2028 for interim reporting periods. The Company is currently evaluating the impact of this ASU on its consolidated financial statements.
3. Property and Equipment, Net
Property and equipment, net consisted of the following (dollar amounts in thousands):
Estimated
Useful Lives
(Years)
September 30,
2025
December
31,
2024
Furniture and fixtures
5
$
249
$
249
Machinery and equipment
5
1,759
1,756
Computer equipment
3
20
20
Leasehold improvements
Lesser of
useful life
or
remaining
lease term
476
476
Work in process
1,876
1,870
Total property and equipment
4,380
4,371
Less: Accumulated depreciation
(
1,399
)
(
1,146
)
Property and equipment, net
$
2,981
$
3,225
4. Accrued Liabilities
Accrued liabilities consisted of the following (in thousands):
September 30,
December
31,
2025
2024
Accrued research and development
$
348
$
545
Accrued income taxes
692
—
Accrued employee costs
—
2,159
Accrued professional fees
460
37
Accrued expense
90
226
$
1,590
$
2,967
11
5
.
Royalty Purchase and Sale Agreement
On August 8, 2022 (the “Closing Date”), the Company, through its wholly owned subsidiary Clearside Royalty LLC, a Delaware limited liability company ("Royalty Sub"), entered into the Purchase and Sale Agreement (the "Purchase and Sale Agreement") with entities managed by HealthCare Royalty Management, LLC ("HCR"), pursuant to which Royalty Sub sold to HCR certain of its rights to receive royalty and milestone payments payable to Royalty Sub under the Arctic Vision License Agreement (as defined in Note 10), the Bausch License Agreement (as defined in Note 10), that certain License Agreement, effective as of July 3, 2019, by and between the Company and Aura Biosciences, Inc. (the “Aura License Agreement”), that certain Option and License Agreement, dated as of August 29, 2019, by and between REGENXBIO Inc. and the Company (the “REGENXBIO License Agreement”), and any and all out-license agreements following the Closing Date f
or, or related to XIPERE or the SCS Microinjector technology (to be used in connection with compounds or products of any third parties) delivered, in whole or in part, by means of the SCS Microinjector technology) (collectively, "Post-Closing License Agreement"), excluding, for the avoidance of doubt, any in-licensed or internally developed therapies following the Closing Date (collectively, the “Royalties”), in exchange for up to $
65
million. In connection with this transaction, the Company assigned the Arctic Vision License Agreement, Bausch License Agreement, Aura License Agreement, REGENXBIO License Agreement, the Company's license agreement with Emory University and The Georgia Tech Research Corporation and related intellectual property rights to Royalty Sub. On November 1, 2023, the Company entered into the BioCryst License Agreement (as defined in Note 10). The Company’s rights to milestone payments and royalties under the BioCryst License Agreement were sold to HCR pursuant to the terms of the Purchase and Sale Agreement providing for the sale of Royalties from Post-Closing License Agreements to HCR.
Under the terms of the Purchase and Sale Agreement, Royalty Sub received an initial payment of $
32.1
million, representing the $
32.5
million to which the Company was entitled, net of certain of HCR's transaction-related expenses which the Company agreed to reimburse. There were additional issuance costs of $
1.5
million related to the Purchase and Sale Agreement resulting in net proceeds of $
30.6
million. An additional $
12.5
million (the "First Milestone Payment") was deposited by HCR in an escrow account which was released to HCR pursuant to the Letter Agreement described below.
Under the terms of the original Purchase and Sales Agreement, the
Purchase and Sale Agreement will automatically expire, and the payment of Royalties from the Royalty Sub to HCR will cease, when HCR has received payments of the Royalties equal to 3.4 times the aggregate amount of payments under the Purchase and Sale Agreement (the “Cap Amount”). In the event of a change in control, acquiror will have the option to make a payment to HCR of the Cap Amount, less the aggregate amount of Royalty payments made by Royalty Sub to HCR under the Purchase and Sale Agreement as a one-time payment at which time, payment of Royalties to HCR will cease. Alternatively, in the event of a change in control, the acquiror will have the option to make an initial payment of 1.0 times the aggregate amount of payments made by HCR under the Purchase and Sale Agreement as of the date of such change in control, then in that event, payment of Royalties from Royalty Sub to HCR will cease when HCR has received total Royalties payments (including the initial payment) equal to the Cap Amount. After the Purchase and Sale Agreement expires, all rights to receive the Royalties return to Royalty Sub.
On December 22, 2023, the Company, through its wholly owned subsidiary Royalty Sub, entered into the Letter Agreement with the Agent amending the Purchase and Sale Agreement. Pursuant to the terms of the Letter Agreement, Royalty Sub and Agent mutually agreed that Royalty Sub waived any and all rights to the First Milestone Payment in connection with the closing of the transactions contemplated by the Purchase and Sale Agreement and agreed to the release of the First Milestone Payment to Agent.
Issuance costs pursuant to the Purchase and Sale Agreement consisting primarily of advisory and legal fees, totaled $
1.9
million including the amount of HCR's transaction-related expenses that the Company reimbursed. The effective interest rate includes cash flow projections for future royalty and milestone payments, which are sensitive to certain assumptions, including market size, market penetration and sales price, that are forward looking and could be affected by future market conditions. The Company estimates the amount and timing of expected payments based on historical experience and its expectations of future activities from its license partners, as well as current market conditions.
Pursuant to the Purchase and Sale Agreement, in August 2022, Royalty Sub sold HCR certain of its rights to receive royalty and milestone payments payable Royalty Sub under existing license agreements related to XIPERE (triamcinolone acetonide injectable suspension) or the Company’s SCS Microinjector technology (collectively, the “Royalties”), and Royalty Sub received $
32.5
million.
On August 8, 2022, the Company and HCR Clearside SPV, LLC (the “Purchaser Agent”) entered into a Pledge and Security Agreement (as amended to date, the “Pledge Agreement”), pursuant to which the Company pledged the capital stock of Royalty Sub to secure the obligations of Royalty Sub under the Purchase and Sale Agreement. Purchaser Agent is entitled to foreclose on such capital stock following the occurrence of certain events.
On September 4, 2025, pursuant to the Amendment, Royalty Sub received an additional payment of $
2.9
million representing the $
3.0
million to which the Royalty Sub was entitled, less $
0.1
million
of transaction expenses, from HCR, which Royalty Sub then paid to the Company in exchange for the remaining assets related to the Company’s SCS Microinjector technology. In addition, in exchange for the additional transferred assets, the Purchaser also agreed to (i) reduce the amount of aggregate Royalties required for the Purchase
12
and
Sale Agreement to expire, and the payment of Royalties from the Royalty Sub to the Purchaser to cease, from $
110.5
million to $
106.5
million, (ii) specified exceptions to its right to receive change of control payments and (iii) a waiver of its right to foreclose on the capital stock of the Seller in specified circumstances.
The following table summarizes the activity of the Purchase and Sale Agreement (in thousands):
Balance at December 31, 2023
$
41,988
Non-cash interest expense
9,779
Balance at December 31, 2024
51,767
Proceeds, net of issuance costs
2,895
Payments
(
1,500
)
Non-cash interest expense
8,005
Balance at September 30, 2025
$
61,167
Effective interest rate
13.7
%
6. Common Stock
At the Company's 2025 annual meeting of stockholders held on May 30, 2025, the Company's stockholders approved an amendment to the Company's Amended and Restated Certificate of Incorporation to increase the Company's authorized number of shares of common stock from
13,333,333
to
26,666,666
.
On September 12, 2025, the Company effected a 1-for-15 reverse stock split of its issued and outstanding shares of common stock.
As of September 30, 2025, the Company was authorized to issue
26,666,666
shares of common stock, $
0.001
par value.
On August 29, 2025, the Company held a special meeting of stockholders at which its stockholders approved a proposal to effect an amendment to the Company’s Amended and Restated Certificate of Incorporation to implement the Reverse Stock Split. On September 4, 2025, the Company’s Board of Directors approved the filing of a certificate of amendment to the Company’s Restated Certificate of Incorporation with the Secretary of State of the State of Delaware to affect the Reverse Stock Split.
On September 12, 2025, the Company effected the Reverse Stock Split. Pursuant to their terms, a proportionate adjustment was made to the per share exercise price and number of shares issuable under all of the Company’s outstanding options and warrants, and the number of shares authorized for issuance pursuant to the Company’s equity incentive plans have been reduced proportionately.
As of September 30, 2025 and December 31, 2024, there were
5,233,981
and
5,105,216
shares of common stock outstanding, respectively.
7. Common Stock Warrants
In September 2016, in connection with a loan agreement, the Company issued warrants to purchase up to
1,986
shares of common stock at a price per share of $
161.10
. The warrants are fully exercisable and expire in
September 2026
, or earlier upon the occurrence of specified mergers or acquisitions of the Company.
The warrants were recorded in equity at the time of issuance and as of September
30, 2025, had a weighted average remaining life of
1.0
years.
On February 6, 2024, the Company entered into a securities purchase agreement with institutional investors and an existing stockholder, pursuant to which the Company issued and sold, in a registered direct offering (i) an aggregate of
740,740
shares (the "Shares") of its common stock; and (ii) warrants to purchase up to
740,740
shares of common stock (the "Warrants").
The combined purchase price of each Share and accompanying Warrant was $
20.25
. The exercise price for the Warrants is $
24.30
per share. The Warrants are currently exercisable and will expire on
August 9, 2029
. The Company recorded the initial fair value of the Warrants of $
10.3
million as warrant liabilities and $
4.7
million attributable to common stock as additional paid in capital in the consolidated balance sheets. The issuance costs were allocated among the Warrants and common stock consistent with the allocation between amounts recorded as warrant liabilities and common stock. The issuance costs allocated to the Warrants as well as the change in the fair value of the Warrants during the period are recorded in other income, net in the consolidated statements of operations. The issuance costs allocated to common stock were recorded as a reduction to additional paid in capital.
The following table summarizes the change in fair value of the warrant liabilities (in thousands):
Fair value of warrants at issuance February 9, 2024
$
10,327
Change in fair value during the period
(
3,635
)
Fair value of warrants at December 31, 2024
6,692
Change in fair value during the period
(
5,500
)
Fair value of warrants at September 30, 2025
$
1,192
13
The following table summarizes certain key inputs for the valuation of the Warrants at
September 30 2025:
Common stock price
$
3.97
Exercise price per share
$
24.30
Expected volatility
80.40
%
Risk-free interest rate
3.61
%
Contractual term (in years)
3.86
Expected dividend yield
—
%
As described in Note 2, the measurement of the warrant liabilities is impacted by the likelihood of achieving certain future milestone events and the related impact to the Company’s stock price. In determining the likelihood of achieving certain future milestone events, the Company considers its current financial position and ability to fund future clinical activities as described in Note 1. The Company utilizes publicly available information from external parties to assess the related impact to the Company’s stock price from the success of these activities.
8. Share-Based Compensation
Share-based compensation is accounted for in accordance with the provisions of ASC 718,
Compensation-Stock Compensation
.
Stock Options
The Company has granted stock option awards to employees, directors and consultants from its 2011 Stock Incentive Plan (the “2011 Plan”) and its 2016 Equity Incentive Plan (the “2016 Plan”). The estimated fair value of options granted is determined as of the date of grant using the Black-Scholes option pricing model. The resulting fair value is recognized ratably over the requisite service period, which is generally the vesting period of the awards.
Share-based compensation expense for options granted under the 2016 Plan is reflected in the consolidated statements of operations as follows (in thousands):
Three Months Ended
September 30,
Nine Months Ended
September 30,
2025
2024
2025
2024
Research and development
$
292
$
386
$
794
$
1,190
General and administrative
385
521
1,119
1,383
Total
$
677
$
907
$
1,913
$
2,573
The following table summarizes the activity related to stock options granted under the 2011 Plan and the 2016 Plan during the nine months ended
September 30, 2025:
Weighted
Number of
Average
Shares
Exercise Price
Options outstanding at December 31, 2024
842,867
$
36.97
Granted
171,695
14.20
Forfeited
(
45,830
)
19.16
Options outstanding at September 30, 2025
968,732
33.78
Options exercisable at December 31, 2024
509,428
47.90
Options exercisable at September 30, 2025
634,079
42.59
As of September 30, 2025, the Company
had $
3.4
million of unrecognized compensation expense related to unvested stock options, which is expected to be recognized over a weighted average period of
2.3
years.
Restricted Stock Units
The Company has granted restricted stock units (“RSUs”) to employees and consultants under the 2016 Plan. The shares underlying the RSU awards have vesting terms of four years from the date of grant subject to the recipient's continuous service and subject to accelerated vesting in specified circumstances. The fair value of the RSUs granted is measured based on the market value of
14
the Company’s common stock on the date of grant and is recognized ratably over the requisite service period, which is generally the vesting period of the awards.
The total share-based compensation expense related to RSUs is reflected in the consolidated statements of operations as follows (in thousands):
Three Months Ended
September 30,
Nine Months Ended
September 30,
2025
2024
2025
2024
Research and development
$
34
$
118
$
117
$
355
General and administrative
35
137
126
410
Total
$
69
$
255
$
243
$
765
The following table summarizes the activity related to RSUs during the nine months ended
September 30, 2025:
Weighted Average
Number of
Grant Date
Shares
Fair Value
Non-vested RSUs outstanding at December 31, 2024
29,155
$
44.36
Vested
(
20,721
)
49.04
Non-vested RSUs outstanding at September 30, 2025
8,434
32.85
As of September
30, 2025, the Company had $
0.1
million of unrecognized compensation expense related to the RSUs which is expected to be recognized over a weighted average period of
0.3
years.
9. Commitments and Contingencies
Lease Commitment Summary
In November 2022, the Company signed an amended office lease agreement to lease approximately
14,000
square feet of office space in Alpharetta, Georgia for its corporate headquarters. The amended office lease agreement is for a
four year
term with a renewal option for an additional 38 months. Rental payments are $
30,747
per month subject to an increase of
3
% per year. Rent expense under this lease is recognized on a straight-line basis over the term of the lease. In addition, the office lease agreement requires payment of the pro-rata share of the annual operating expenses associated with the premises.
The Company recognizes a right-of-use asset for the right to use the underlying asset for the lease term, and a lease liability, which represents the present value of the Company’s obligation to make payments over the lease term.
The renewal option is not included in the calculation of the right-of-use asset and the lease liabilities as the Company has not yet determined if the Alpharetta, Georgia lease will be renewed.
Equipment leases with an initial term of 12 months or less are not recorded with operating lease liabilities. The Company recognizes expense for these leases on a straight-line basis over the lease term. The equipment leases were deemed to be immaterial.
Georgia Tech License Agreement
As described in Note 1, the Company entered into a fourth amendment to the Georgia Tech License Agreement pursuant to which the parties agreed to revised Maintenance Fee payments in exchange for a reduction to the contractual Sublicense Percentage owed by the Company on certain fees and other payments it may receive from future sublicensing activities. The Company paid the $
0.3
million Maintenance Fee for 2023 in February 2024 and the $
0.3
million Maintenance Fee for 2024 in October 2024.
The remaining annual Maintenance Fee payments are due on October 1st of each year from 2025 through 2028, as shown in the table below (in thousands).
Year Ending December 31,
Amount
2025
$
250
2026
350
2027
400
2028
500
Total
$
1,500
Contract Service Providers
In the course of the Company’s normal business operations, it has agreements with contract service providers to assist in the performance of its research and development, clinical research and manufacturing. Substantially all of these contracts are on an as needed basis.
15
10. License and Other Agreements
Bausch + Lomb
On October 22, 2019, the Company entered into a License Agreement (as amended, the "Bausch License Agreement") with Bausch + Lomb (“Bausch”). Pursuant to the Bausch License Agreement, the Company has granted an exclusive license to Bausch to develop, manufacture, distribute, promote, market and commercialize XIPERE using the Company’s proprietary SCS Microinjector (the “Device”), as well as specified other steroids, corticosteroids and NSAIDs in combination with the Device (together with XIPERE, the “Products”), subject to specified exceptions, in the United States and Canada (the “Territory”) for the treatment of ophthalmology indications, including non-infectious uveitis.
Pursuant to the Bausch License Agreement, Bausch paid the Company an aggregate of $
20.0
million in upfront and milestone payments.
In addition, Bausch has agreed to pay up to an aggregate of $
55.0
million in additional milestone payments upon the achievement of (i) specified regulatory approvals for specifi
ed additional indications of XIPERE and (ii) specified levels of annual net sales (as defined in the Bausch License Agreement). Further, during the applicable royalty term, the Company will also be entitled to receive tiered royalties at increasing percentages, from the high-teens to twenty percent, based on XIPERE achieving certain annual net sales thresholds in the Territory, in each case subject to reductions in specified circumstances; provided that the Company will not receive any royalties on the first $
45.0
million of cumulative net sales of all products in the Territory. Bausch launched XIPERE in the United States in the first quarter of 2022. The Company's rights to these royalties and milestone payments have been sold pursuant to the terms and conditions of the Purchase and Sale Agreement described in Note 5.
The Company was responsible for all development expenses for XIPERE in the Territory until the Company's New Drug Application ("NDA") was approved by the U.S. Food and Drug Administration ("FDA"), subject to specified exceptions, as well as manufacturing costs in connection with the NDA. The Company was also responsible for all clinical and development expenses conducted to satisfy the FDA’s requests in the complete response letter issued on October 18, 2019 related to the NDA. Following FDA approval of XIPERE, which occurred in October 2021, Bausch is responsible for all such expenses.
Arctic Vision (Hong Kong) Limited
On March 10, 2020, the Company entered into a License Agreement (the “Arctic License Agreement”) with Arctic Vision (Hong Kong) Limited (“Arctic Vision”). Pursuant to the Arctic License Agreement, the Company has granted an exclusive license to Arctic Vision to develop, distribute, promote, market and commercialize XIPERE, subject to specified exceptions, in China, Hong Kong, Macau, Taiwan and South Korea (the “Arctic Territory”). Under the terms of the Arctic License Agreement, neither party may commercialize XIPERE in the other party’s territory. Arctic Vision has agreed to use commercially reasonable efforts to pursue the development and commercialization of XIPERE for indications associated with uveitis in the Arctic Territory. In addition, upon receipt of the Company’s consent, Arctic Vision will have the right, but not the obligation, to develop and commercialize XIPERE for additional indications in the Arctic Territory.
Pursuant to the Arctic License Agreement, Arctic Vision has paid the Company an aggregate
of $
10.5
million in upf
ront and milestone payments. In addition, Arctic Vision has agreed to pay the Company up
to $
22.0
million in
development and sales milestones. Further, during the applicable royalty term, the Company will also be entitled to receive tiered royalties of
ten
to
twelve
percent of net sales based on achieving certain annual net sales thresholds in the Arctic Territory, subject to customary reductions, payable on a product-by-product and country-by-country basis, commencing at launch in such country and lasting until the latest of (i) the date that all valid claims within the licensed patent rights covering XIPERE have expired, (ii) the date of the loss of marketing or regulatory exclusivity of XIPERE in a given country, or (iii) ten years from the first commercial sale of XIPERE in a given country. The Company's rights to these royalties and milestone payments have been sold pursuant to the terms and conditions of the Purchase and Sale Agreement described in Note 5.
In August 2021, the Company entered into an amendment to the Arctic License Agreement to expand the territories covered by the license to include India and the ASEAN Countries (Brunei, Cambodia, Indonesia, Laos, Malaysia, Myanmar, the Philippines, Singapore, Thailand, and Vietnam). In September 2021, the Company entered into a second amendment to the Arctic Vision License Agreement to expand the Arctic Territory to include Australia and New Zealand. The Company
received an aggregate of $
3.0
million in consideration for the expansion of the Arctic Territory.
BioCryst Pharmaceuticals, Inc.
On November 1, 2023, the Company entered into the BioCryst License Agreement pursuant to which the Company granted BioCryst an exclusive, worldwide and sublicensable license to the Company’s SCS Microinjector for the delivery of BioCryst’s proprietary plasma kallikrein inhibitor known as avoralstat for the treatment and prevention of diabetic macular edema.
The Company received an upfront license fee payment of $
5.0
million in connection with signing of the BioCryst License Agreement. In addition, the Company is eligible to receive up to an additional $
30.0
million in clinical and regulatory milestone payments, and up to a total of $
47.5
million in a series of post-approval sales-based milestone payments based on the achievement of annual global net product sales milestones up to $
2.0
billion. Further, during the royalty term, BioCryst has also agreed to pay the Company tiered mid-single digit royalties on annual global net product sales, with the highest royalty rate applied to sales over $
1.5
16
billion,
subject to reductions in specified circumstances.
The Company's rights to these royalties and milestone payments have been sold pursuant to the terms and conditions of the Purchase and Sale Agreement described in Note 5.
BioCryst will be responsible for all development, regulatory and commercialization activities for avoralstat. The Company is responsible for supplying SCS Microinjectors to meet BioCryst’s reasonable needs.
Other
The Company periodically enters into short-term agreements with other customers to evaluate the potential use of its proprietary SCS Microinjector with third-party product candidates for the treatment of various diseases. Funds received from these agreements are recognized as revenue over the term of the agreement.
11. Fair Value Measurements
The Company’s material financial instruments at September 30, 2025 and December 31, 2024 consisted of cash and cash equivalents. The fair values of cash and cash equivalents, other current assets and accounts payable approximate their respective carrying values due to the short term nature of these instruments and are classified as Level 1 in the fair value hierarchy. The fair value of the warrant liabilities (see Note 7) require significant unobservable inputs and is classified as Level 3 in the fair value hierarchy.
There were
no
transfers between Levels 1, 2 and 3 during the nine months ended
September
30, 2025 and the year ended December 31, 2024.
12. Related Party Transactions
A member of the Company's Board of Directors was the chief executive officer of a company that is a vendor of the Company until January 2025. As of December 31, 2024, the Company has recorded $
0.5
million in accounts payable and $
0.3
million in accrued expense with this vendor in the consolidated balance sheet. The Company has recorded $
0.3
million and $
0.5
million for the three and nine months ended September 30, 2024, respectively, of expense related to this vendor in the consolidated statement of operations.
The chair of the board of directors of BioCryst also serves on the Company’s Board of Directors. The Company has recorded $
0.2
million and $
81,000
for the three months ended
September
30, 2025 and 2024, respectively, and $
0.5
million and $
0.2
million for the nine months ended in
September 30 2025 and 2024, respectively, in license and other revenue in the consolidated statements of operations related to the BioCryst License Agreement.
A former member of the Company's Board of Directors is the chief financial officer of Aura Biosciences. The Company has recorded $
945
and $
4,185
in license and other revenue in the consolidated statement of operations related to the Aura License Agreement for three and nine month periods ending
September
30, 2025, respectively.
13. Net Loss Per Share
Basic net loss per share is calculated by dividing the net loss by the weighted average number of shares of common stock outstanding for the period, without consideration of the dilutive effect of potential common stock equivalents. Diluted net loss per share gives effect to all dilutive potential shares of common stock outstanding during this period. For all periods presented, the Company’s potential common stock equivalents, which included stock options, restricted stock units and common stock warrants, have been excluded from the computation of diluted net loss per share as their inclusion would have the effect of reducing the net loss per share. Therefore, the denominator used to calculate both basic and diluted net loss per share is the same in all periods presented.
The Company’s potential common stock equivalents that have been excluded from the computation of diluted net loss per share for all periods presented because of their antidilutive effect consisted of the following:
Nine Months Ended
September 30,
2025
2024
Outstanding stock options
968,732
850,094
Non-vested restricted stock units
8,434
29,153
Common stock warrants
742,726
742,726
1,719,892
1,621,973
17
Item 2. Management’s Discussion and Analysis of
Financial Condition and Results of Operations.
Certain statements contained in this Quarterly Report on Form 10-Q may constitute forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. The words or phrases “would be,” “will allow,” “intends to,” “will likely result,” “are expected to,” “will continue,” “is anticipated,” “estimate,” “project,” or similar expressions, or the negative of such words or phrases, are intended to identify “forward-looking statements.” We have based these forward-looking statements on our current expectations and projections about future events. Because such statements include risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Factors that could cause or contribute to these differences include those below and elsewhere in this Quarterly Report on Form 10-Q and our other filings with the Securities and Exchange Commission, or SEC, under the heading “Risk Factors”. Statements made herein are as of the date of the filing of this Form 10-Q with the SEC and should not be relied upon as of any subsequent date. Unless otherwise required by applicable law, we do not undertake, and we specifically disclaim, any obligation to update any forward-looking statements to reflect occurrences, developments, unanticipated events or circumstances after the date of such statement.
The following discussion and analysis of our financial condition and results of operations should be read in conjunction with our unaudited consolidated financial statements and related notes that appear in Item 1 of this Quarterly Report on Form 10-Q and with our audited consolidated financial statements and related notes for the year ended December 31, 2024 appearing in our Annual Report on Form 10-K filed with the SEC on March 27, 2025.
Overview
We are a biopharmaceutical company focused on revolutionizing the delivery of therapies to the back of the eye into the suprachoroidal space, or SCS
®
. Our novel SCS injection platform, utilizing our proprietary SCS Microinjector
®
, enables an in-office, repeatable, non-surgical procedure for the targeted and compartmentalized delivery of a wide variety of therapies to all layers of the posterior segment of the eye to potentially preserve and improve vision in patients with sight-threatening eye diseases. Our SCS injection platform can be used in conjunction with existing drugs designed for delivery to the SCS, novel therapies and future therapeutic innovations. We believe our proprietary suprachoroidal administration platform has the potential to become a standard for delivery of therapies intended to treat chorioretinal diseases.
We are leveraging our SCS injection platform with an internal research and development pipeline targeting
chorioretinal
diseases and through external collaborations with other companies. We have our own pipeline of small molecule product candidates for administration via our SCS Microinjector, and we also strategically partner with companies developing other ophthalmic therapeutic innovations to be administered using our SCS injection technology. Our first product, XIPERE
®
(triamcinolone acetonide injectable suspension) for suprachoroidal use, was approved by the U.S. Food and Drug Administration, or the FDA, in October 2021. Approval of XIPERE was a significant milestone for us as it is the first approved therapeutic delivered into the SCS, the first commercial product developed by us and the first therapy for macular edema associated with uveitis.
Commercial Product
XIPERE
®
(triamcinolone acetonide injectable suspension) for suprachoroidal use, was approved by the FDA in October 2021. XIPERE is the first approved therapeutic delivered into the SCS, the first commercial product developed by us and the first therapy for macular edema associated with uveitis. XIPERE commercialization rights are licensed to Bausch + Lomb in the United States and Canada and Arctic Vision in the Asia Pacific region, not including Japan. In July 2025, Health Canada granted approval for XIPERE for the treatment of uveitic macular edema.
Operating Outlook and Strategic Review
We have incurred net losses since our inception. In recent years, our operations have consisted primarily of conducting preclinical studies and clinical trials, raising capital and undertaking other research and development initiatives. To date, we have primarily generated revenue through upfront payments and milestone payments related to license agreements and from collaboration agreements, and we have primarily financed our operations through public offerings and private placements of our equity securities, issuance of warrants, issuances of convertible promissory notes and loan agreements. As of September 30, 2025, we had an accumulated deficit of 374.0 million. We recorded net losses of $6.0 million and $7.7 million for the three months ended September 30, 2025 and 2024, respectively, and net losses of $18.7 million and $27.0 million for the nine months ended September 30, 2025 and 2024, respectively.
In July 2025, we announced plans to explore a full range of strategic alternatives to advance our SCS platform and drug development pipeline to maximize stockholder value. We have retained Piper Sandler, a leading investment bank with substantial experience in the biotechnology industry, to support us with the strategic evaluation process. Strategic alternatives under consideration include the sale, license, monetization and/or divestiture of one or more of our assets and technologies, collaboration, partnership,
18
merger, acquisition, joint ventures or other strategic transactions. If a strategic alternative is not available, we will be required to take additional actions to fund our operations, or we may be forced to file for bankruptcy or wind down our operations.
Based on our current plans and forecasted expenses and our cash and cash equivalents, we do not believe we will be able to fund our operations for the next 12 months from the date of this filing. These factors raise substantial doubt regarding our ability to continue as a going concern. Our consolidated financial statements have been prepared on a going concern basis, which contemplates the realization of assets and satisfaction of liabilities in the normal course of business. The consolidated financial statements do not include any adjustments to reflect the possible future effects on the recoverability and classification of recorded asset amounts or the amounts and classification of liabilities that might result should we be unable to continue as a going concern.
Macroeconomic Conditions
Unfavorable conditions in the economy in the United States and abroad may negatively affect the growth of our business and our results of operations. For example, macroeconomic events, rising inflation, the U.S. Federal Reserve raising interest rates, and conflicts in Ukraine, Russia and the Middle East have led to economic uncertainty globally. The effect of macroeconomic conditions may not be fully reflected in our results of operations until future periods. If, however, economic uncertainty increases or the global economy worsens, our business, financial condition and results of operations may be harmed. For further discussion of the potential impacts of macroeconomic events on our business, financial condition, and operating results, see “Risk Factors” included in Part I, Item 1A of the Annual Report on Form 10-K filed with the SEC on March 27, 2025.
Components of Operating Results
License and Other Revenue
We have not generated any revenue from the sale of XIPERE and we do not expect to generate any other product revenue unless or until we obtain regulatory approval for and commercialize our other product candidates, either on our own or with a third party. The revenue received under the Bausch license agreement, as well as other certain payments from our licensees, will be recorded as non-cash revenue until we have fulfilled our obligations under the Purchase and Sale Agreement. Our revenue in recent years has been generated primarily from our license agreements. We are seeking to enter into additional licenses and other agreements with third parties to evaluate the potential use of our proprietary SCS Microinjector with the third party’s product candidates for the treatment of various eye diseases. These agreements may include payments to us for technology access, upfront license payments, regulatory and commercial milestone payments and royalties.
Costs of Goods Sold
Cost of goods sold are related to the sales of our SCS Microinjector kits to our licensees for approved products.
Research and Development
Research and development expenses have historically consisted primarily of costs incurred for the research and development of our preclinical and clinical product candidates, which include:
•
employee-related expenses, including salaries, benefits, travel and share-based compensation expense for research and development personnel;
•
expenses incurred under agreements with contract research organizations, or CROs, as well as contract manufacturing organizations and consultants that conduct clinical trials and preclinical studies;
•
costs associated with preclinical activities and clinical trials;
•
costs associated with submitting regulatory approval applications for our product candidates;
•
costs associated with training physicians on the suprachoroidal injection procedure and educating and providing them with appropriate product candidate information;
•
costs associated with technology and intellectual property licenses;
•
costs for our research and development facility; and
•
depreciation expense for assets used in research and development activities.
We expense research and development costs to operations as incurred. These costs include preclinical activities, such as manufacturing and stability and toxicology studies, that are supportive of a product candidate itself. In addition, there are expenses related to clinical trials and similar activities for each program, including costs associated with CROs. Clinical costs are recognized based on the terms of underlying agreements, as well as an evaluation of the progress to completion of specific tasks using data such as participant enrollment, clinical site activations and additional information provided to us by our vendors about their actual costs
19
incurred. Expenses related to activities that support more than one development program or activity, such as salaries, share-based compensation and depreciation, are not classified as direct preclinical costs or clinical costs and are separately classified as unallocated.
The following table shows our research and development expenses by program for the three and nine months ended September 30, 2025 and 2024 (in thousands).
Three Months Ended
September 30,
Nine Months Ended
September 30,
2025
2024
2025
2024
CLS-AX (wet AMD program)
$
25
$
942
$
688
$
4,963
GA (geographic atrophy)
58
53
523
53
Total
83
995
1,211
5,016
Unallocated
2,850
3,133
7,769
9,330
Total research and development expense
$
2,933
$
4,128
$
8,980
$
14,346
Our expenses related to clinical trials are based on estimates of participant enrollment and related expenses at clinical investigator sites as well as estimates for the services received and efforts expended under contracts with research institutions, consultants and CROs that conduct and manage clinical trials on our behalf. We generally accrue expenses related to clinical trials based on contracted amounts applied to the level of participant enrollment and activity according to the protocol. If future timelines or contracts are modified based upon changes in the clinical trial protocol or scope of work to be performed, we would modify our estimates of accrued expenses accordingly on a prospective basis.
As discussed in more detail under “—Operating Outlook and Strategic Review” above, in July 2025, we announced plans to explore a full range of strategic alternatives to advance our SCS platform and drug development pipeline to maximize stockholder value. We paused all internal research and development programs during the pendency of this process. Accordingly, we expect research and development expenses will continue to decrease in future periods relative to the corresponding periods of 2024.
General and Administrative
General and administrative expenses consist primarily of salaries and other related costs, including share-based compensation, for personnel in executive, finance and administrative functions. General and administrative costs historically included commercial pre-launch preparations for XIPERE, and also include facility related costs not otherwise included in research and development expenses, as well as professional fees for legal, patent, consulting, and accounting and audit services.
Interest Income
Interest income consists of the accrued interest and interest income earned on our cash and cash equivalents.
Other Income, Net
Other income, net consists of expenses allocated to the warrants issued in connection with our registered direct offering in February 2024 and the change in fair value of the warrants during the periods.
Non-cash Interest Expense on Liability Related to the Sales of Future Royalties
Non-cash interest expense on liability related to the sales of future royalties consists of imputed interest on the carrying value of the liability and the amortization of the related issuance costs.
Income Tax Expense
Income tax expense consists of taxes incurred in foreign jurisdictions.
Critical Accounting Policies and Significant Judgments and Estimates
Our management’s discussion and analysis of our financial condition and results of operations is based on our consolidated financial statements, which have been prepared in accordance with U.S. generally accepted accounting principles or U.S. GAAP. The preparation of these consolidated financial statements requires us to make estimates, judgments and assumptions that affect the reported amounts of assets and liabilities, disclosure of contingent assets and liabilities as of the dates of the consolidated balance sheets and the reported amounts of expenses during the reporting periods. In accordance with U.S. GAAP, we evaluate our estimates and judgments on an ongoing basis. Significant estimates include certain assumptions used in royalty financing obligation, certain assumptions used in the valuation of warrant liabilities and certain assumptions used to estimate research and development expenses, including clinical trials. We base our estimates on historical experience and on various other factors that we believe are reasonable under the circumstances, the results of which form the basis for making judgments about the carrying value of assets and liabilities
20
that are not readily apparent from other sources. Actual results may differ from these estimates under different assumptions or conditions.
We define our critical accounting policies, in accordance with U.S. GAAP, as those that require us to make subjective estimates and judgments about matters that are uncertain and are likely to have a material impact on our financial condition and results of operations, as well as the specific manner in which we apply those principles. During the nine months ended September 30, 2025, there were no significant changes to our critical accounting policies disclosed in our audited consolidated financial statements for the year ended December 31, 2024, which are included in our Annual Report on Form 10-K, as filed with the SEC on March 27, 2025.
Results of Operations for the Three Months Ended September 30, 2025 and 2024
The following table sets forth our results of operations.
Three Months Ended
September 30,
Period-to-Period
2025
2024
Change
(in thousands)
License and other revenue
$
201
$
1,038
$
(837
)
Operating expenses:
Research and development
2,933
4,128
(1,195
)
General and administrative
4,308
2,844
1,464
Total operating expenses
7,241
6,972
269
Loss from operations
(7,040
)
(5,934
)
(1,106
)
Interest income
65
338
(273
)
Other income, net
3,573
365
3,208
Non-cash interest expense on liability
related to the sales of future royalties
(2,570
)
(2,457
)
(113
)
Net loss
(5,972
)
(7,688
)
1,716
License and other revenue
. In the three months ended September 30, 2025 and 2024, we recognized $0.2 million and $1.0 million, respectively, of revenue associated with our license agreements. License revenue and other revenue for the three months ended September 30, 2025 consisted of revenue for training and services. License revenue and other revenue for the three months ended September 30, 2024 consisted of revenue for training, services and the sales of our SCS Microinjector kits to our licensees.
Research and development
. Research and development expenses decreased by $1.2 million from $4.1 million for the three months ended September 30, 2024 to $2.9 million for the three months ended September 30, 2025. This decrease was primarily due to a $0.9 million decrease in costs related to the CLS-AX program due to the completion of ODYSSEY, our Phase 2b clinical trial and a $1.2 million increase in employee related severance costs due to the reduction in force, partially offset by a $1.4 million decrease in salary and other related benefits.
General and administrative
. General and administrative expenses increased by $1.5 million from $2.8 million for the three months ended September 30, 2024 to $4.3 million for the three months ended September 30, 2025. This increase was primarily due to a $1.1 million increase in professional services, a $1.1 million increase in employee related severance costs due to the reduction in force and a $0.6 million increase in consulting fees, partially offset by a $0.9 million decrease in salary and other related benefits.
Interest income.
Interest income decreased by $0.3 million from $0.3 million for the three months ended September 30, 2024 to $65,000 for the three months ended September 30, 2025. The decrease was due to the lower balance of our cash and cash equivalents.
Other income, net.
Other income, net was $3.6 million for the three months ended September 30, 2025 and $0.4 million for the three months ended September 30, 2024. The change was due to a larger decline in the fair value of the warrant liabilities from the December 31, 2024 valuation date to September 30, 2025 than as compared to the decline in fair value from the February 2024 issuance date to September 30, 2024.
Non-cash interest expense on liability related to the sales of future royalties
. Non-cash interest expense on liability related to the sales of future royalties was $2.6 million and $2.5 million for the three months ended September 30, 2025 and 2024, respectively, and was comprised of imputed interest on the liability related to the sales of future royalties and the amortization of the associated issuance costs.
21
Results of Operations for the Nine Months Ended September 30, 2025 and 2024
The following table sets forth our results of operations.
Nine Months Ended
September 30,
Period-to-Period
2025
2024
Change
(in thousands)
License and other revenue
$
3,023
$
1,358
$
1,665
Operating expenses:
Cost of goods sold
248
—
248
Research and development
8,980
14,346
(5,366
)
General and administrative
9,608
8,745
863
Total operating expenses
18,836
23,091
(4,255
)
Loss from operations
(15,813
)
(21,733
)
5,920
Interest income
343
1,104
(761
)
Other income, net
5,500
783
4,717
Non-cash interest expense on liability
related to the sales of future royalties
(8,005
)
(7,200
)
(805
)
Loss before income taxes
(17,975
)
(27,046
)
9,071
Income tax expense
715
—
715
Net loss
$
(18,690
)
$
(27,046
)
$
8,356
License and other revenue
. In the nine months ended September 30, 2025 and 2024, we recognized $3.0 million and $1.4 million, respectively, of revenue associated with our license agreements. License revenue and other revenue for the nine months ended September 30, 2025 consisted of $1.5 million in milestones from Arctic Vision and $1.5 million in other revenue for training, services and the sales of our SCS Microinjector kits to our licensees. License revenue and other revenue for the nine months ended September 30, 2024 consisted of $1.4 million for training, services and the sales of our SCS Microinjector kits to our licensees.
Cost of goods sold.
In the nine months ended September 30, 2025, we recognized $0.2 million in cost of goods sold related to the sales of our SCS Microinjector kits to our licensees of approved products.
Research and development
. Research and development expenses decreased by $5.4 million from $14.3 million for the nine months ended September 30, 2024 to $9.0 million for the nine months ended September 30, 2025. This decrease was primarily due to a $4.3 million decrease in costs related to the CLS-AX program due to the completion of ODYSSEY, our Phase 2b clinical trial, a $0.7 million decrease in employee related costs due to the reduction in force and $0.4 million decrease related to a research and development tax credit received in the nine months ended September 30, 2025. This decrease was partially offset by a $0.5 million increase in costs related to the GA program.
General and administrative
. General and administrative expenses increased by $0.9 million from $8.7 million for the nine months ended September 30, 2024 to $9.6 million for the nine months ended September 30, 2025. This increase was primarily due to a $1.4 million increase in professional fees, $0.8 million increase in consulting fees and a $0.5 million increase in employee related costs due to the reduction in force. This is partially offset by a $0.5 million decrease in patent expense.
Interest income.
Interest income decreased by $0.8 million from $1.1 million for the nine months ended September 30, 2024 to $0.3 million for the nine months ended September 30, 2025. The decrease was due to the lower balance of our cash and cash equivalents.
Other income, net.
Other income, net was $5.5 million for the nine months ended September 30, 2025 and $0.8 million for the nine months ended September 30, 2024. The change was due to a larger decline in in the fair value of the warrant liabilities from the December 31, 2024 valuation date to September 30, 2025 than as compared to the decline in fair value from the February 2024 issuance date to September 30, 2024.
Non-cash interest expense on liability related to the sales of future royalties
. Non-cash interest expense on liability related to the sales of future royalties was $8.0 million and $7.2 million for the nine months ended September 30, 2025 and 2024, respectively, and was comprised of imputed interest on the liability related to the sales of future royalties and the amortization of the associated issuance costs.
Income tax expense.
Income tax expense is due to taxes on milestone revenue incurred in foreign jurisdictions.
22
Liquidity and Capital Resources
Sources of Liquidity
We have funded our operations primarily through the proceeds of public offerings of our common stock, sales of convertible preferred stock, issuance of warrants and the issuance of long-term debt. As of September 30, 2025, we had cash and cash equivalents of $6.8 million. We invest any cash in excess of our immediate requirements primarily with a view to liquidity and capital preservation. As of September 30, 2025, our funds were held in cash and money market funds.
On September 4, 2025, we entered into an Omnibus Amendment Agreement, or the Amendment, with Clearside Royalty LLC, a wholly owned subsidiary of the Company, or the Seller, Healthcare Royalty Partners IV, L.P., or the Purchaser, and HCR Clearside SPV, LLC, or the Purchaser Agent. The Amendment, among other things, amends (i) the Purchase and Sale Agreement, dated as of August 8, 2022, or the Purchase and Sale Agreement, by and among the Seller, the Purchaser and the Purchaser Agent, (ii) the Contribution and Servicing Agreement, dated August 8, 2022, as amended to date, by and between us and Seller and (iii) the Pledge and Security Agreement, dated as of August 8, 2022, as amended to date, by and between the Company and the Purchaser Agent.
Pursuant to the Purchase and Sale Agreement, in August 2022, the Seller sold to Purchaser certain of its rights to receive royalty and milestone payments payable to Seller under existing license agreements related to XIPERE (triamcinolone acetonide injectable suspension) or our SCS Microinjector technology (collectively, the “Royalties”), and the Seller received $32.5 million. Pursuant to the Pledge Agreement, we pledged the capital stock of the Seller to secure the obligations of the Seller under the Purchase and Sale Agreement. Purchaser Agent is entitled to foreclose on such capital stock following the occurrence of certain events.
Pursuant to the Amendment, the Seller received an additional $3.0 million from the Purchaser, which the Seller then paid to us in exchange for the remaining assets related to our SCS Microinjector technology. In addition, in exchange for the additional transferred assets, the Purchaser also agreed to (i) reduce the amount of aggregate Royalties required for the Purchase and Sale Agreement to expire, and the payment of Royalties from the Royalty Sub to the Purchaser to cease, from $110.5 million to $106.5 million, (ii) specified exceptions to its right to receive change of control payments and (iii) a waiver of its right to foreclose on the capital stock of the Seller in specified circumstances.
On February 6, 2024, we entered into a securities purchase agreement, pursuant to which we issued and sold, in a registered direct offering: (i) an aggregate of 740,740 shares of our common stock; and (ii) warrants to purchase up to 740,740 shares of common stock, or Warrants. The combined purchase price of each share and accompanying Warrant was $20.25. The exercise price for the Warrants is $24.30 per share. The Warrants are currently exercisable and will expire on August 9, 2029. The net proceeds to us from the registered direct offering were $13.9 million.
On January 31, 2024, or the Amendment Effective Date, we entered into a fourth amendment to the license agreement, or the Emory License Agreement, with Emory University and Georgia Tech Research Corporation, or, collectively, the Licensor, pursuant to which the parties agreed to reduce the Sublicense Percentage (as defined in the Emory License Agreement) from a low double digit percentage to a high single digit percentage that we will pay the Licensor applicable to any fees or payments paid to us by any Sublicensee (as defined in the Emory License Agreement) of the Licensed Patents and/or Licensed Technology (each as defined in the Emory License Agreement), excluding (i) amounts paid to us by a Sublicensee to reimburse us for certain research and development costs pursuant to a written agreement between us and such Sublicensee, (ii) the value of intellectual property transferred or granted to us if necessary or helpful to the development or commercialization of Licensed Products (as defined in the Emory License Agreement) and (iii) amounts paid for shares of our stock. The payment to Licensor of any such Sublicense Percentage is due within 30 days of receipt by us of a qualifying payment from a Sublicensee, provided however, with respect to any qualifying payments received by us from a Sublicensee prior to January 1, 2025, the payment to Licensor of any such Sublicensee Percentage is due to Licensor by March 31, 2025. The parties also agreed to a revised annual license maintenance fee due each year, or the Maintenance Fee, starting in 2023 through 2028, as follows: $0.3 million for 2023 through 2025, $0.4 million for each of 2026 and 2027 and $0.5 million for 2028. The remaining annual Maintenance Fee payments are due on October 1st of each year.
In May 2023, we entered into a Controlled Equity Offering
SM
Sales Agreement, or the Sales Agreement, with Cantor Fitzgerald & Co., or Cantor, under which we may offer and sell, from time to time at our sole discretion, shares of our common stock, having an aggregate offering price of up to $50.0 million through Cantor as our sales agent. During the nine months ended September 30, 2025, we sold 109,957 shares of our common stock for net proceeds of $1.4 million under the Sales Agreement. During the nine months ended September 30, 2024, we sold 22,656 shares of our common stock for net proceeds of $0.5 million under the Sales Agreement.
Funding Requirements
Our primary uses of capital are, and we expect will continue to be, compensation and related expenses, research and development costs to build our product candidate pipeline, legal and other regulatory expenses and general overhead costs as we explore strategic alternatives. In addition, we have certain contractual obligations for future payments. Refer to Note 5 to our consolidated financial statements included in this Quarterly Report on Form 10-Q.
23
The successful development of our product candidates is highly uncertain. As such, at this time, we cannot reasonably estimate or know the nature, timing and estimated costs of the efforts that will be necessary to complete the remainder of the development of CLS-AX or any future product candidates. We are also unable to predict when, if ever, material net cash inflows will commence from product sales. This is due to the numerous risks and uncertainties associated with developing drugs, including the uncertainty of:
•
successful enrollment in, and completion of, clinical trials;
•
receipt of marketing approvals from applicable regulatory authorities;
•
establishing commercial manufacturing capabilities or making arrangements with third-party manufacturers;
•
obtaining and maintaining patent and trade secret protection and regulatory exclusivity for our product candidates; and
•
launching commercial sales of the products, if and when approved, whether alone or in collaboration with others.
A change in the outcome of any of these variables with respect to the development of any of our product candidates would significantly change the costs and timing associated with the development of that candidate.
Until such time, if ever, as we can generate substantial product revenue, we may seek to finance our cash needs through a combination of equity offerings, debt financings and potential collaboration, license and development agreements. Other than potential payments we may receive under our license and other agreements, we do not currently have any committed external source of funds, though, as described above, we may also be able to sell our common stock under the Sales Agreement subject to the terms of that agreement and depending on market conditions. We expect that we will require additional capital to fund our ongoing operations. Additional funds may not be available to us on a timely basis, on commercially reasonable terms, or at all. Our ability to raise additional capital may be adversely impacted by potential worsening global economic conditions and disruptions to, and volatility in, the credit and financial markets in the United States and worldwide and related macroeconomic changes, such as rising inflation. To the extent that we raise additional capital through the sale of equity or convertible debt securities, your ownership interest will be diluted, and the terms of these securities may include liquidation or other preferences that adversely affect your rights as a common stockholder. Debt financing and preferred equity financing, if available, may involve agreements that include covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making capital expenditures or declaring dividends.
If we raise funds through additional collaborations, strategic alliances or marketing, distribution or licensing arrangements with third parties, including any future collaboration or licensing arrangement for XIPERE outside of the territories in which we have previously licensed or granted options to license XIPERE, we may be required to relinquish additional rights to our technologies, future revenue streams, research programs or product candidates or to grant licenses on terms that may not be favorable to us. If we are unable to raise additional funds through equity or debt financings when needed, we may be required to delay, limit, reduce or terminate our drug development or future commercialization efforts or grant rights to develop and market product candidates that we would otherwise prefer to develop and market ourselves.
We also incur costs as a public company, including costs and expenses for fees to members of our board of directors, accounting and finance personnel costs, directors and officers insurance premiums, audit and legal fees, investor relations fees and expenses for compliance with reporting requirements under the Exchange Act and rules implemented by the SEC and Nasdaq.
Outlook
We have suffered recurring losses and negative cash flows from operations since inception and anticipate incurring additional losses until such time, if ever, that we can generate significant milestone payments and royalties from XIPERE and other licensing arrangements or revenues from other product candidates. We will need additional financing to fund our operations. Our plans primarily consist of raising additional capital, potentially in a combination of equity or debt financings, monetizing royalties, or restructurings, or potentially entering into additional collaborations, partnerships and other strategic arrangements.
Based on our current plans and forecasted expenses, including the impact of our recent announcement to explore strategic alternatives, we do not believe our cash and cash equivalents will be able to fund our operations for the next 12 months from the date of this filing. In order to conserve our cash balance we have paused all internal research and development programs which can be resumed if we are able to raise additional capital.
These factors raise substantial doubt regarding our ability to continue as a going concern. Our consolidated financial statements have been prepared on a going concern basis, which contemplates the realization of assets and satisfaction of liabilities in the normal course of business. The consolidated financial statements do not include any adjustments to reflect the possible future effects on the recoverability and classification of recorded asset amounts or the amounts and classification of liabilities that might result should we be unable to continue as a going concern.
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Cash Flows
The following is a summary of the net cash flows (used in) provided by our operating, investing and financing activities (in thousands):
Nine Months Ended
September 30,
2025
2024
Net cash (used in) provided by:
Operating activities
$
(16,039
)
$
(19,444
)
Investing activities
(9
)
(9,945
)
Financing activities
2,829
14,357
Net change in cash and cash equivalents
$
(13,219
)
$
(15,032
)
During the nine months ended September 30, 2025 and 2024, our operating activities used net cash of $16.0 million and $19.4 million, respectively. The net cash used in operating activities for the nine months ended September 30, 2025 was due to ongoing research and development expenses to develop our pipeline, general and administrative costs and $2.3 million in severance and related costs was paid to employees due to the reduction in force. The net cash used in operating activities for the nine months ended September 30, 2024 was due to ongoing research and development expenses to develop our pipeline and costs for ODYSSEY, as well as the supporting general and administrative costs.
During the nine months ended September 30, 2025 and 2024, our investing activities used net cash of $9,000 and $9.9 million, respectively. The net cash used in investing activities for the nine months ended September 30, 2025 consisted of the acquisition of property and equipment. The net cash used in investing activities for the nine months ended September 30, 2024 consisted of $16.9 million for the purchase of short-term investments and $0.5 million for the acquisition of property and equipment, partially offset by $7.5 million received upon the maturity of short-term investments.
During the nine months ended September 30, 2025 and 2024, our financing activities provided net cash of $2.8 million and $14.3 million, respectively. The net cash provided by financing activities for the nine months ended September 30, 2025 consisted primarily of $2.9 million of net proceeds from the Purchase and Sale Agreement and proceeds of $1.4 million from the sale of shares of our common stock under the Sales Agreement. This is partially offset by $1.5 million payment related to the royalty purchase and sale agreement. The net cash provided by financing activities for the nine months ended September 30, 2024 consisted primarily of $13.9 million of net proceeds from the sale of shares of our common stock and warrants in a registered direct offering and $0.5 million of net proceeds from the sale of shares of our common stock under the Sales Agreement.
Item 3. Quantitative and Qualitati
ve Disclosures about Market Risk
We are a smaller reporting company as defined by Rule 12b-2 of the Exchange Act and are not required to provide the information required under this item.
Item 4. Controls
and Procedures
Evaluation of Disclosure Controls and Procedures
The term “disclosure controls and procedures,” as defined in Rules 13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934, as amended (the “Exchange Act”), refers to controls and procedures that are designed to ensure that information required to be disclosed by a company in the reports that it files or submits under the Exchange Act is recorded, processed, summarized and reported, within the time periods specified in the SEC’s rules and forms. Disclosure controls and procedures include, without limitation, controls and procedures designed to ensure that such information is accumulated and communicated to a company’s management, including its principal executive and principal financial officers, as appropriate to allow timely decisions regarding required disclosure.
In designing and evaluating our disclosure controls and procedures, management recognizes that disclosure controls and procedures, no matter how well conceived and operated, can provide only reasonable, not absolute, assurance that the objectives of the disclosure controls and procedures are met. Additionally, in designing disclosure controls and procedures, our management necessarily was required to apply its judgment in evaluating the cost-benefit relationship of possible disclosure controls and procedures. The design of any system of controls also is based in part upon certain assumptions about the likelihood of future events, and there can be no assurance that any design will succeed in achieving its stated goals under all potential future conditions; over time, controls may become inadequate because of changes in conditions, or the degree of compliance with policies or procedures may deteriorate. Because of the inherent limitations in a control system, misstatements due to error or fraud may occur and not be detected.
Our management, with the participation of our Chief Executive Officer and our Chief Financial Officer, has evaluated the effectiveness of our disclosure controls and procedures as of the end of the period covered by this report. Based on that evaluation, our
25
Chief Executive Officer and our Chief Financial Officer concluded that our disclosure controls and procedures were effective as of the end of the period covered by this report at the reasonable assurance level.
Changes in Internal Control over Financial Reporting
There has been no change in our internal control over financial reporting during the quarter ended September 30, 2025 that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting. We have not experienced any material impact to our internal control over financial reporting.
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PART II – OTHE
R INFORMATION
Item 1. Legal
Proceedings
From time to time, we may be subject to litigation and claims arising in the ordinary course of business. We are not currently a party to any material legal proceedings and we are not aware of any pending or threatened legal proceeding against us that we believe could have a material adverse effect on our business, operating results, cash flows or financial condition.
Ite
m 1A. Risk Factors
Our business is subject to risks and events that, if they occur, could adversely affect our financial condition and results of operations and the trading price of our securities. In addition to the other information set forth in this quarterly report on Form 10-Q, you should carefully consider the factors described in “Part I, Item 1A. Risk Factors” of our Annual Report on Form 10-K for the fiscal year ended December 31, 2024, filed with the Securities and Exchange Commission on March 27, 2025.
Risks Related to Our Financial Position, Capital Needs and Strategic Review
We do not currently have sufficient working capital to fund our planned operations for the next twelve months and substantial doubt exists as to our ability to continue as a going concern
.
Our historical financial statements have been prepared under the assumption that we will continue as a going concern. As of September 30, 2025, we had an accumulated deficit of $374.0 million and had cash and cash equivalents of $6.8 million. While we have begun to implement cost reductions in 2025, we have finite cash resources available to fund our operations. As part of cost reductions, we implemented a plan pursuant to which we terminated all employees and transitioned such persons into consulting roles. We incurred charges of approximately $2.3 million for severance and other employee termination-related costs in the third quarter of 2025. The estimated charges that we expect to incur are subject to a number of assumptions, and actual results may differ materially from these estimates. We may also incur additional costs not currently contemplated due to events that may occur as a result of, or that are associated with, our workforce reduction. The reduction in force is expected to be completed during the third quarter of 2025.
In July 2025, we announced plans to explore a full range of strategic alternatives to advance our SCS platform and drug development pipeline to maximize stockholder value. We have retained Piper Sandler, a leading investment bank with substantial experience in the biotechnology industry, to support us with the strategic evaluation process. Strategic alternatives under consideration include the sale, license, monetization and/or divestiture of one or more of our assets and technologies, collaboration, partnership, merger, acquisition, joint ventures or other strategic transactions.
These conditions raise substantial doubt about our ability to continue as a going concern within one year after the date the financial statements are issued. Based on our current plans and forecasted expenses and our cash and cash equivalents, we do not believe we will be able to fund our operations for the next 12 months from the date of this filing. Until we can generate sufficient revenue, if ever, to fund our operations, we will need to finance future cash needs through public or private equity offerings, license agreements, debt financings or restructurings, collaborations, strategic alliances and marketing or distribution arrangements.
The perception of our ability to continue as a going concern may make it more difficult for us to obtain financing for the continuation of our operations and could result in the loss of confidence by investors and employees. Additional financing may not be available to us when needed or, if available, it may not be obtained on commercially reasonable terms. If we are not able to obtain the necessary additional financing and if a strategic alternative is not available, we may be forced to file for bankruptcy or wind down our operations.
Our activities to evaluate and pursue potential strategic alternatives may not result in any transaction or enhance stockholder value. If we do not successfully consummate a strategic alternative, our board of directors may decide to file for bankruptcy, wind down our operations, or pursue a dissolution and liquidation of our company. In such an event, the amount available for distribution to our common stockholders could be as low as zero and result in a total loss of investment to our stockholders.
We have begun evaluating and exploring a variety of strategic alternatives focused on maximizing stockholder value, including, but not limited to, an acquisition, merger, reverse merger, other business combination, sales of assets or other strategic transactions. Our ability to successfully execute on a strategic alternative is dependent on a number of factors and we may not be able to execute upon a transaction or other strategic alternative upon favorable terms within an advantageous timeframe and recognize significant value for our assets, if at all. Additionally, the negotiation and consummation of a transaction or other strategic alternative may be costly and time-consuming. Any executed strategic alternative may not maximize or even enhance stockholder value, could result in total costs and expenses that are greater than expected, could make it more difficult to attract and retain qualified personnel and may disrupt our operations, each of which could have a material adverse effect on our business.
The market price of our common stock may reflect a market assumption that a strategic alternative will occur, and a failure to complete a strategic alternative could result in negative investor perceptions and could cause a decline in the market price of our common stock, which could adversely affect our ability to access the equity and financial markets, as well as our ability to explore and
27
enter into different strategic alternatives. There can be no certainty that any strategic alternative will be completed, be on attractive terms, enhance stockholder value or deliver the anticipated benefits, and successful integration or execution of the strategic alternatives will be subject to additional risks. In addition, potential strategic alternatives that require stockholder approval may not be approved by our stockholders. If we do not successfully consummate a strategic alternative, our board of directors may decide to file for bankruptcy, wind down our operations, or pursue a dissolution and liquidation of our company. In such an event, the amount of cash available for distribution to our stockholders will depend heavily on the timing of such liquidation, the amount of cash that will need to be reserved for commitments and contingent liabilities. Depending on these factors, the amount available for distribution to our common stockholders could be as low as zero and result in a total loss of investment to our stockholders.
In the event we file for bankruptcy, we would be subject to the risks and uncertainties associated with such proceedings.
In the event we file for relief under the United States Bankruptcy Code, our operations and our continuation as a going concern will be subject to the risks and uncertainties associated with bankruptcy proceedings. Any delays in our bankruptcy proceedings would increase the risks of our being unable to reorganize our business and emerge from bankruptcy proceedings and may increase our costs associated with the bankruptcy process or result in prolonged operational disruption for us. Also, we would need the prior approval of the bankruptcy court for transactions outside the ordinary course of business during the course of any bankruptcy proceedings, which may limit our ability to respond timely to certain events or take advantage of certain opportunities. Because of the risks and uncertainties associated with any bankruptcy proceedings, we cannot accurately predict or quantify the ultimate impact of events that could occur during any such proceedings. There can be no guarantees that if we file for bankruptcy we will emerge from bankruptcy as a going concern or that holders of our common stock will receive any recovery from any bankruptcy proceedings.
Risks Related to Ownership of Our Common Stock
If we are unable to maintain listing of our common stock on Nasdaq or any stock exchange, our stock price could be adversely affected and the liquidity of our stock and our ability to obtain financing could be impaired and it may be more difficult for our stockholders to sell their securities.
Although our common stock is currently listed on Nasdaq, we may not be able to continue to meet the exchange’s minimum listing requirements or those of any other national exchange. The Listing Rules of Nasdaq require listing issuers to comply with certain standards in order to remain listed on its exchange. For example, on August 28, 2025, we received a notice from the Nasdaq notifying us that the listing of our common stock was not in compliance with the minimum Market Value of Listed Securities of $50,000,000 required for continued listing on The Nasdaq Global Market, as set forth in Nasdaq Listing Rule 5450(b)(2)(A), or the MVLS Requirement. We have a period of 180 calendar days, or until February 24, 2026, or the Compliance Date, to regain compliance with the MVLS Requirement. To regain compliance, our MVLS must close at $50,000,000 or more for a minimum of 10 consecutive business days prior to the Compliance Date. In the event we do not regain compliance with the MVLS Requirement prior to the Compliance Date, Nasdaq will notify us that our securities are subject to delisting, at which point we may appeal the delisting determination to a Nasdaq hearings panel.
If for any reason, we should fail to maintain compliance with these listing standards in the future and Nasdaq should delist our securities from trading on its exchange and we are unable to obtain listing on another national securities exchange, we anticipate that our securities would begin trading on the over-the-counter market. Delisting from Nasdaq and trading on the over-the-counter market could adversely affect the liquidity of our securities. Securities traded on the over-the-counter market generally have limited trading volume and exhibit a wider spread between the bid/ask quotation, as compared to securities listed on a national securities exchange. Consequently, you may not be able to liquidate your investment in the event of an emergency or for any other reason.
If Nasdaq delists our securities from trading on its exchange for failure to meet the listing standards, we and our stockholders could face significant negative consequences including limited availability of market quotations for our securities, a determination that the common stock is a “penny stock” which will require brokers trading in the common stock to adhere to more stringent rules, possibly resulting in a reduced level of trading activity in the secondary trading market for shares of the common stock, a limited amount of analyst coverage, and a decreased ability to issue additional securities or obtain additional financing in the future.
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Item 2.
Unregistered Sales of Equity Securities and Use of Proceeds
Sales of Unregistered Securities
None.
Issuer Purchases of Equity Securities
None.
Item 5. Other Information
During the quarter ended September 30, 2025, none of our directors or officers (as defined in Rule 16a-1(f) under the Exchange Act)
adopted
,
modified
or
terminated
a “Rule 10b5-1 trading arrangement” or a “non-Rule 10b5-1 trading arrangement” (as each term is defined in Item 408 of Regulation S-K).
Inline XBRL Taxonomy Extension Schema Document with Embedded Linkbase Documents
104
Cover Page Interactive Data File (formatted as inline XBRL and contained in Exhibits 101)
*
Filed herewith.
+
Pursuant to Item 601(b)(10)(iv) of Regulation S-K promulgated by the Securities and Exchange Commission, certain portions of this exhibit (indicated by asterisks) have been omitted because they are not material and are the type that the Registrant treats as private or confidential. The Registrant hereby agrees to furnish supplementally to the Securities and Exchange Commission, upon its request, an unredacted copy of this exhibit.
**
These certifications are being furnished solely to accompany this quarterly report pursuant to 18 U.S.C. Section 1350, and are not being filed for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, and are not to be incorporated by reference into any filing of the registrant, whether made before or after the date hereof, regardless of any general incorporation language in such filing.
30
S
IGNATURES
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.
Clearside Biomedical, Inc.
Date: November 14, 2025
By:
/s/ Charles A. Deignan
Charles A. Deignan
Chief Financial Officer
(On behalf of the Registrant and as
Principal Financial Officer)
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