OCULAR THERAPEUTIX, INC
For the period ended Sep 30, 2025. Filed Nov 4, 2025.
View on SEC.govAbout this filing
A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.
Sep 30, 2025 · Filed Nov 4, 2025
OCUL$6.60+2.6%Stored close · as of Nov 6, 2026
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-Q
Period ended 2025-06-30; filed 2025-08-05.
0001558370-25-010177
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2025-09-30; filed 2025-11-04.
0001104659-25-105919
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsThe baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.
Compared 138 previous paragraphs and 169 current paragraphs.
63 unchanged; 52 reworded; 48 added; 20 removed; 3 previous and 6 current paragraphs rearranged.
Tables are not compared: 56 previous and 57 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.
A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.
Added paragraphs (48)
Current report
The SOL-1 trial involves more than 100 trial sites located in the United States and Argentina. The SOL-1 trial completed the randomization of 344 subjects with a diagnosis of active macular choroidal neovascularization at screening in December 2024. Under the trial protocol, subjects were eligible for enrollment in the SOL-1 trial if they were treatment-naïve for wet AMD in the study eye; had central subfield thickness, or CSFT, of less than or equal to 500 microns; and had a Best Corrected Visual Acuity, or BCVA, of at least 54 letters as measured by the Early Treatment of Diabetic Retinopathy Study, or ETDRS, letters chart (approximately 20/80 Snellen equivalent vision). After screening, enrolled subjects received two aflibercept 2 mg loading doses at Weeks -8 and -4. Subjects reaching either a BCVA of greater than or equal to 84 ETDRS letters (approximately 20/20 Snellen equivalent vision) or experiencing an improvement of at least 10 ETDRS letters with a reduction in CSFT to no greater than 350 microns after these injections were randomized in the trial.
Current report
The primary endpoint of the SOL-1 trial is the proportion of subjects who maintain visual acuity, defined as a loss of fewer than 15 ETDRS letters from baseline, at Week 36. One of the secondary endpoints being evaluated is the proportion of subjects who maintain visual acuity measured at Week 52. At Weeks 52 and 76, all subjects that were randomized in the trial at Day 1, including subjects who previously received supplemental anti-vascular endothelial growth factor, or anti-VEGF treatment, are re-dosed with their respective initial treatment of a single injection of
Current report
Retention in the trial continues to be outstanding, with greater than 95% of randomized subjects remaining on-trial to date, and rescues reviewed under masking shows greater than 95% of rescue events to date have met pre-established protocol-defined criteria. Oversight by an independent data and safety monitoring committee has not identified any safety signals in the SOL-1 trial to date.
Current report
We are conducting the SOL-1 trial in accordance with a special protocol assessment, or SPA, agreement with the FDA. We continue to expect topline results for the SOL-1 trial to be available in the first quarter of 2026 after the completion of the Week 52 visits for all subjects in the trial.
Current report
Over the six months prior to randomization, enrolled subjects are given three screening doses of any anti-VEGF therapy, excluding brolucizumab-dbll, and monitored to exclude subjects demonstrating early persistent fluid or significant retinal fluid fluctuations. Subjects maintaining a CSFT of no greater than 350 microns at Weeks -12 and -8 and not experiencing a CSFT increase of greater than 35 microns from their lowest CSFT at any prior visit then receive two loading doses of aflibercept 2 mg at Weeks -8 and -4 prior to randomization.
Current report
Subjects in the first arm of the SOL-R trial receive a single dose of AXPAXLI 450 μg at Day 1 and are re-dosed at Weeks 24, 48, and 72. Subjects in the second arm receive aflibercept 2 mg on-label every eight weeks. Subjects in the third arm receive a single dose of aflibercept 8 mg at Day 1 and are re-dosed at Weeks 24, 48, and 72.
Current report
The primary endpoint of SOL-R is to demonstrate non-inferiority in mean BCVA change from baseline between the AXPAXLI and on-label aflibercept 2 mg arms at Week 56. The third arm of the SOL-R trial, which has only been included for masking purposes, is not part of the non-inferiority analysis. Based on FDA guidance, the non-inferiority margin for the lower bound for the trial has been established at -4.5 letters of mean BCVA.
Current report
On November 4, 2025, we announced that the SOL-R trial has achieved its randomization target of 555 subjects. We will continue to allow randomization of previously enrolled subjects currently in the loading phase of the trial to maintain our commitment to both patients and investigators, with topline data remaining on track for the first half of 2027.
Current report
The SOL-X Trial
Current report
We plan to initiate a long-term, multi-center, open-label extension clinical trial, which we refer to as the SOL-X trial, to evaluate subjects who have completed their two-year safety follow-up visits in either the SOL-1 or SOL-R trials for an additional three years. The primary objectives of the planned SOL-X trial are to evaluate the long-term safety of AXPAXLI; to explore long-term visual outcomes, including visual acuity and the incidence and/or progression of fibrosis and macular atrophy; and to evaluate the impact of delayed initiation of AXPAXLI in patients who initially were randomized to receive aflibercept in either SOL-1 or SOL-R. According to the planned trial design, subjects enrolled in
Current report
the SOL-X trial are to receive AXPAXLI 450 μg every 24 weeks and are to be evaluated at Week 4, Week 12, and every 12 weeks thereafter.
Current report
AXPAXLI for Diabetic Eye Disease
Current report
Diabetic Eye Disease
Current report
Diabetic eye disease is an increasingly prevalent global health concern, driven by the rapidly rising number of individuals diagnosed with diabetes each year.
Current report
Diabetic retinopathy, or DR, is the most common category of retinal diseases, affecting over an estimated 103 million people worldwide. DR is a progressive condition in which retinal blood vessels are damaged following a cascade of events triggered by chronically elevated levels of blood glucose. As many as half of all diabetic patients are expected to develop some form of DR in their lifetime. DR can progress from the non-proliferative stages, or the NPDR stages, to the proliferative stage, or the PDR stage, characterized by the growth of abnormal new blood vessels. The severity of DR is commonly assessed using an objective severity score based on graded retinal images, which is referred to as the diabetic retinopathy severity score, or DRSS. Based on third-party market research data, we estimate that fewer than 1% of the 6.4 million NPDR patients in the U.S. receive treatment today, despite the availability of anti-VEGF therapies approved for the indication, largely due to the burden of frequent injections.
Current report
Diabetic macular edema, or DME, is also a leading cause of vision loss in the working-age population. DME, the result of an accumulation of fluid in the macula that can afflict patients with diabetes, can occur at any stage of DR. In patients with DME, blood vessels in the eyes leak and start to swell, which can cause vision loss or blindness. Anti-VEGF drugs are approved to treat DME, but these treatments typically require frequent intravitreal injections, placing a significant burden on patients and physicians alike.
Current report
DR Program Highlights
Current report
In September 2025, we announced plans to initiate two superiority registrational trials of AXPAXLI for the treatment of NPDR, which we refer to as the HELIOS-2 and HELIOS-3 trials. We plan to target a broad label in DR by including subjects with non-center-involved DME, or non-CI-DME. We are preparing to initiate the HELIOS registrational program imminently with the goal of evaluating 6- and 12-month dosing intervals.
Current report
The HELIOS-2 and HELIOS 3 trials will leverage a novel ordinal primary endpoint of 2 or more steps on the DRSS. Historically, DR trials have relied on binary endpoints measuring either an improvement of 2 or more steps in DRSS or the prevention of a 2 or more step DRSS worsening have been used as binary endpoints. The HELIOS program will be the first time an ordinal endpoint is being used in DR trials, which means the statistical analysis will measure changes across the DRSS spectrum, including disease improvement, stability, and worsening. These are all clinically meaningful measures for retina specialists in the context of a disease that gets progressively worse if untreated. The use of the novel ordinal endpoint means that every patient will contribute data to the statistical analysis, allowing for a smaller trial size to achieve statistically significant outcomes relative to the size required for a binary analysis. We believe the ordinal DRSS endpoint enables a higher probability of success with smaller, shorter, more relevant, and less expensive trials, relative to other potential endpoints.
Current report
In August 2025, we received written agreement regarding the overall design of the HELIOS-2 clinical trial, including the proposed novel ordinal endpoint and statistical analysis plan, from the FDA under an SPA agreement.
Current report
The HELIOS-2 Trial
Current report
We plan to initiate the HELIOS-2 trial, a Phase 3 clinical trial to evaluate the safety and efficacy of AXPAXLI in
Current report
approximately 432 subjects with moderately severe to severe NPDR without center-involved DME, or CI-DME. The planned HELIOS-2 trial is designed to be a multi-center, double-masked, randomized (1:1), parallel-group, two-arm superiority trial comparing a single injection of AXPAXLI 450 μg to a single injection of ranibizumab 0.3 mg. The trial is expected to include subjects with non-CI-DME.
Current report
According to the planned trial design, eligible subjects in the HELIOS-2 trial will be randomized to receive either a single dose of AXPAXLI 450 μg or a single dose of ranibizumab. At Week 52, all subjects that were randomized in the trial will be re-dosed with their respective initial treatments. Subjects will be assessed monthly through Year 1 and every other month thereafter for safety through the end of Year 2. Subjects and designated trial personnel will remain masked through the end of Year 2.
Current report
The primary endpoint of the HELIOS-2 clinical trial is subjects’ ordinal 2-step DRSS change status from baseline—comparing whether subjects have experienced at least a two-step improvement, at least a two-step worsening, or less than a two-step change in either direction—assessed at Week 52.
Current report
The HELIOS-3 Trial
Current report
We also plan to initiate the HELIOS-3 trial, a second Phase 3 clinical trial to evaluate the safety and efficacy of AXPAXLI in approximately 930 subjects with moderately severe to severe NPDR without CI-DME. The planned HELIOS-3 trial is designed to be a multi-center, double-masked, randomized (1:1:1), three-arm superiority trial comparing two dosing regimens of AXPAXLI to a sham comparator. Similar to the HELIOS-2 trial, the HELIOS-3 clinical trial is also expected to include subjects with non-CI-DME.
Current report
According to the planned trial design, eligible subjects in the HELIOS-3 trial will be randomized as follows: subjects in the first arm will receive a single injection of AXPAXLI 450 μg at Day 1 and will be re-dosed with AXPAXLI 450 μg at Week 24; subjects in the second arm will receive a single injection of AXPAXLI 450 μg at Day 1 and a sham injection at Week 24; and subjects in the third arm will receive sham injections at both Day 1 and Week 24. Subjects will be assessed every three months throughout the trial, and subjects and designated trial personnel will remain masked through the end of Week 52.
Current report
The primary endpoint of the HELIOS-3 clinical trial is identical to the primary endpoint of the HELIOS-2 trial, subjects’ ordinal 2-step DRSS change status from baseline as assessed at Week 52.
Current report
Update on Intellectual Property Portfolio in Connection with AXPAXLI
Current report
In September 2025, we received a notice of allowance from the United States Patent and Trademark Office in connection with a patent application submitted by us that recites claims covering methods of treating ocular diseases with AXPAXLI. This notice of allowance resulted in the issuance of a U.S. patent in October 2025. Subject to any patent term adjustments that we may obtain, we expect this patent to expire in 2044. We will continue to prosecute our patents and patent applications for AXPAXLI and our other product candidates and technologies in the United States and various other jurisdictions around the world.
Current report
We completed a pilot repeat-dose sub-study in a subset of subjects from our Phase 2 clinical trial of OTX-TIC to evaluate the safety of a repeat, sustained release dose of OTX-TIC 26 µg. Subjects in the primary Phase 2 study who had received either OTX-TIC 26 μg or DURYSTA and who did not require rescue therapy during the primary study (prior to Visit 10) were eligible to participate in the repeat dose sub-study. Subjects who had received OTX-TIC 26 µg in the primary study received a repeat-dose of OTX-TIC 26 μg in the sub-study once the initial dose of OTX-TIC from the primary study had fully reabsorbed (6 patients at sub-study enrollment; 3 additional patients received sham at sub-study enrollment and OTX-TIC 26 μg at a later study visit following full reabsorption). As DURYSTA cannot be administered more than once in the same eye, there were 16 subjects who received DURYSTA in the primary study who received sham in their assigned study eye in the repeat-dose sub-study. Subjects were followed for at least six months after their enrollment in the sub-study and repeat dosing with OTX-TIC 26 µg or sham.
Current report
Data from the sub-study were consistent with data previously observed in the OTX-TIC primary study. We observed a decrease from baseline (Day 0, Visit 2 of the primary study) in mean intraocular pressure, or IOP, values at 8 AM, 10 AM, and 4 PM at all repeat-dose post-injection visits in the study eye in the OTX-TIC 26 µg group and sham group, with mean IOP values similar or lower than those seen at Month 6 of the primary study. During the repeat-dose sub-study, the mean decrease in diurnal IOP values from baseline was greater at all time points for subjects who received a repeat-dose of OTX-TIC than for subjects who received DURYSTA in the main study and a sham injection in the repeat-dose sub-study.
Current report
OTX-TIC 26 µg was generally well tolerated after both single and repeat dosing in patients with OAG or OHT. In addition, no new safety concerns were identified following repeat-dosing of OTX-TIC 26 µg in the small subset of subjects who participated in the sub-study.
Current report
We are currently evaluating next steps for the OTX-TIC program.
Current report
2025 Offering
Current report
In October 2025, we completed an underwritten offering of 37,909,018 shares of our common stock for an offering price of $12.53 per share (the “2025 Offering”). We received net proceeds of approximately $445.4 million, after deducting underwriting discounts and commissions and estimated other offering expenses, from the 2025 Offering.
Current report
The final Medicare Physician Fee Schedule, or MPFS, for 2026, or the CY 2026 MPFS Final Rule, was released on October 31, 2025. Under the CY 2026 MPFS Final Rule, DEXTENZA remains included in MIPS. We expect the Outpatient Prospective Payment System, or OPPS, rule for 2026 to be released in November 2025.
Current report
Research and development expenses were $52.4 million and $37.1 million for the three months ended September 30, 2025 and 2024, respectively, reflecting an increase of $15.3 million year-over-year.
Current report
Selling and marketing expenses were $13.1 million and $10.6 million for the three months ended September 30, 2025 and 2024, respectively, reflecting an increase of $2.5 million year-over-year.
Showing the first 40 of 48 passages. Open the source sections for the rest.
Removed paragraphs (20)
Previous report
The SOL-1 trial completed the randomization of 344 subjects with a diagnosis of active macular choroidal neovascularization at screening in December 2024. Under the study protocol, after initial screening, every enrolled subject received two aflibercept 2 mg loading doses between the screening visit and Day 1: one at Week -8 and another at Week -4. Subjects reaching approximately 20/20 Snellen equivalent vision or experiencing an improvement of at least 10 ETDRS letters after these injections, in addition to satisfying other criteria, were randomized in the trial at Day 1 to receive either one dose of AXPAXLI 450 µg in the investigational arm or one injection of aflibercept 2 mg in the control arm. At Week 52 and at Week 76, all subjects that were randomized in the trial at Day 1, including subjects who
Previous report
We are conducting the SOL-1 trial in accordance with a Special Protocol Assessment, or SPA, agreement, as modified, with the FDA. In February 2025, the FDA agreed to an amendment to the SPA agreement to add a repeat dose of AXPAXLI 450 µg at Week 52 and at Week 76, in each case, after all pre-defined efficacy endpoint assessments. The SPA agreement amendment allows us to generate the required safety data for subjects re-dosed with AXPAXLI through Week 104, to support repeat dosing.
Previous report
Engagement by subjects and investigator adherence to the rescue protocol of the SOL-1 trial continues to be outstanding. We expect topline results for SOL-1 to be available in the first quarter of 2026.
Previous report
We have completed enrollment in the SOL-R trial and, based on our projected randomization timeline, we expect topline results for SOL-R to be available in the first half of 2027.
Previous report
Long-term extension study for AXPAXLI for wet AMD
Previous report
We plan to incorporate a single long-term, open-label extension study for both SOL trials. Subjects will be eligible to enter the extension study after completing the two-year safety follow-up period in either the SOL-1 trial or the SOL-R trial. In addition to providing long-term safety data, the extension study is expected to further inform the AXPAXLI treatment paradigm and potentially provide several commercial advantages. The extension study is designed to evaluate the long-term safety of AXPAXLI and further explore key efficacy outcomes such as vision preservation, anti-fibrotic
Previous report
activity, and the potential consequences of delaying AXPAXLI treatment in control arm subjects. We expect to provide further details regarding this extension study in the third quarter of 2025.
Previous report
AXPAXLI for NPDR and DME
Previous report
We have completed the HELIOS trial of AXPAXLI for the treatment of NPDR. In the first half of 2025, the FDA provided positive written feedback on the design of a potential registrational clinical trial for AXPAXLI for the treatment of NPDR. We are actively planning our next steps in the development of AXPAXLI for NPDR and DME and expect to provide further details surrounding our clinical strategy for AXPALI for the treatment of NPDR in the third quarter of 2025.
Previous report
We are conducting a pilot repeat-dose sub-study in the Phase 2 clinical trial to evaluate the safety of a repeat, sustained release dose of OTX-TIC 26 μg in a small subset of subjects with OAG or OHT. Once we have completed the pilot repeat-dose sub-study, we plan to evaluate whether an end-of-Phase 2 meeting with the FDA is appropriate for determining our next steps for OTX-TIC for the treatment of OAG or OHT.
Previous report
In June 2024, we submitted the data for our clinical trial to evaluate DEXTENZA in pediatric subjects following cataract surgery to the FDA to fulfill a post-approval requirement of the FDA in connection with the FDA’s prior approval of DEXTENZA for the treatment of inflammation and pain following ophthalmic surgery in adults. We
Previous report
received approval of the supplemental NDA for DEXTENZA on April 7, 2025. Therefore, DEXTENZA is now also approved for use in pediatric patients for the treatment of ocular inflammation and pain following ophthalmic surgery, and in pediatric patients aged 2 years and older for the treatment of ocular itching associated with allergic conjunctivitis. The approval of this supplemental NDA provides for pediatric label expansion. We do not expect to generate significant revenue from the use of DEXTENZA in pediatric patients.
Previous report
Research and development expenses were $51.1 million and $28.9 million for the three months ended June 30, 2025 and 2024, respectively, reflecting an increase of $22.2 million year-over-year.
Previous report
Selling and marketing expenses were $13.7 million and $10.0 million for the three months ended June 30, 2025 and 2024, respectively, reflecting an increase of $3.7 million year-over-year.
Previous report
General and administrative expenses were $14.3 million and $19.7 million for the three months ended June 30, 2025 and 2024, respectively, reflecting a decrease of $5.4 million year-over-year.
Previous report
Comparison of the Six Months Ended June 30, 2025 and 2024
Previous report
Collaboration Revenue
Previous report
Research and development expenses were $93.9 million and $49.6 million for the six months ended June 30, 2025 and 2024, respectively, reflecting an increase of $44.3 million year-over-year.
Previous report
Selling and marketing expenses were $27.9 million and $20.2 million for the six months ended June 30, 2025 and 2024, respectively, reflecting an increase of $7.7 million year-over-year.
Previous report
General and administrative expenses were $30.7 million and $33.8 million for the six months ended June 30, 2025 and 2024, respectively, reflecting a decrease of $3.1 million year-over-year.
Reworded paragraphs (52)
Previous wording
We are an integrated biopharmaceutical company committed to redefining the retina experience. AXPAXLI (also known as OTX-TKI), our investigational product candidate for retinal disease, is an axitinib intravitreal hydrogel based on our ELUTYX proprietary bioresorbable hydrogel-based formulation technology. AXPAXLI is currently in two repeat-dosing Phase 3 clinical trials for the treatment of wet age-related macular degeneration, or wet AMD, which we refer to as the SOL-1 and the SOL-R trials. We have also completed a Phase 1 clinical trial of AXPAXLI for the treatment of non-proliferative diabetic retinopathy, or NPDR, which we refer to as the HELIOS trial. We are currently planning our next steps for AXPAXLI for the treatment of NPDR and diabetic macular edema, or DME.
Current wording
We are an integrated biopharmaceutical company committed to redefining the retina experience. AXPAXLI (also known as OTX-TKI), our investigational product candidate for retinal disease, is an axitinib intravitreal hydrogel based on our ELUTYX proprietary bioresorbable hydrogel-based formulation technology. AXPAXLI is currently in Phase 3 clinical trials for wet age-related macular degeneration, or wet AMD, with a Phase 3 clinical program for non-proliferative diabetic retinopathy, or NPDR, planned to be initiated imminently.
Previous wording
We also leverage the ELUTYX technology in our commercial product DEXTENZA, a corticosteroid approved by the U.S. Food and Drug Administration, or FDA, for the treatment of ocular inflammation and pain following ophthalmic surgery in adults and pediatric patients and for the treatment of ocular itching associated with allergic conjunctivitis in adults and pediatric patients aged two years or older, and in our investigational product candidate OTX-TIC, which is a travoprost intracameral hydrogel that is currently in a Phase 2 clinical trial for the treatment of open-angle glaucoma, or OAG, or ocular hypertension, or OHT.
Current wording
We also leverage the ELUTYX technology in our commercial product DEXTENZA, a corticosteroid approved by the U.S. Food and Drug Administration, or FDA, for the treatment of ocular inflammation and pain following ophthalmic surgery in adults and pediatric patients and for the treatment of ocular itching associated with allergic conjunctivitis in adults and pediatric patients aged two years or older, and in our investigational product candidate OTX-TIC, which is a travoprost intracameral hydrogel that has completed a Phase 2 clinical trial for the treatment of open-angle glaucoma, or OAG, or ocular hypertension, or OHT. We are currently evaluating next steps for the OTX-TIC program.
Previous wording
We are currently conducting the SOL-1 trial, a repeat-dosing registrational Phase 3 clinical trial for the treatment of wet AMD. The SOL-1 trial is designed as a prospective, multi-center, randomized, parallel-group trial that involves more than 100 trial sites located in the United States and Argentina. The SOL-1 trial is designed as a superiority trial comparing a single optimized dose of AXPAXLI with a drug load of 450 µg of axitinib to a single injection of aflibercept 2 mg and assessing the safety and efficacy of AXPAXLI in subjects with wet AMD. The primary endpoint is the proportion of subjects who maintain visual acuity, defined as Best Corrected Visual Acuity, or BCVA, as measured by a loss of fewer than 15 letters on the Early Treatment of Diabetic Retinopathy Study, or ETDRS, letters chart from baseline at Week 36. This superiority trial has an 8-week loading segment with two monthly aflibercept 2 mg intravitreal injections prior to randomization, thereafter a 52-week treatment segment followed by a 52-week safety segment with re-dosing at Weeks 52 and 76. We believe the inclusion of re-dosing in the design of the SOL-1 trial enhances the potential of the trial to support a 6 - 12 month dosing label for AXPAXLI for the treatment of wet AMD and should also provide insights into the long-term durability of AXPAXLI.
Current wording
We are currently conducting the SOL-1 trial, a repeat-dosing registrational Phase 3 clinical trial, to assess the safety and efficacy of AXPAXLI in subjects with wet AMD. The SOL-1 trial is designed as a prospective, multi-center, double-masked, randomized (1:1), parallel-group, two-arm superiority trial comparing a single injection of AXPAXLI with a drug load of 450 µg of axitinib, or AXPAXLI 450 µg, to a single injection of aflibercept 2 mg.
Previous wording
previously received supplemental anti-VEGF treatment, are re-dosed with their respective initial treatment of a single dose of AXPAXLI 450 µg in the investigational arm or a single injection of aflibercept 2 mg in the control arm and followed for safety until Week 104. Throughout the trial, subjects are assessed monthly and remain masked to treatment assignment.
Current wording
AXPAXLI 450 μg in the investigational arm or a single injection of aflibercept 2 mg in the control arm. Subjects will be followed for safety until the end of Year 2.
Previous wording
In June 2024, we initiated the SOL-R trial, a repeat-dosing registrational Phase 3 clinical trial for the treatment of wet AMD. The SOL-R trial is designed as a multi-center, double-masked, randomized (2:2:1), three-arm trial that includes sites located in the U.S., Argentina, India, and Australia. The trial is intended to randomize approximately 555 subjects that are either treatment naïve or have been diagnosed with wet AMD in the study eye within about four months prior to enrollment. This non-inferiority trial reflects a patient enrichment strategy over the six months prior to randomization that includes three screening doses of any anti-VEGF therapy, excluding brolucizumab-dbll, and monitoring to exclude those subjects with significant retinal fluid fluctuations. Subjects that continue to meet eligibility will enter a run-in period and receive two loading doses of aflibercept 2 mg prior to Day 1. In the first arm, subjects will receive a 450 µg dose of AXPAXLI at Day 1 and be re-dosed at Weeks 24, 48, and every 24 weeks thereafter through the end of year 2. In the second arm, subjects will receive aflibercept 2 mg on-label every 8 weeks. In the third arm, subjects will receive an 8 mg dose of aflibercept (Eylea HD) at Day 1 and will be re-dosed at Weeks 24, 48, and every 24 weeks thereafter, corresponding with the AXPAXLI dosing regimen in the first arm to serve as adequate masking pursuant to current FDA guidance. Subjects will be followed for safety until Week 104. Throughout the trial, subjects are assessed monthly. In June 2025, based on investigator feedback, and as part of our ongoing effort to ensure that the SOL-R trial reflects real-world clinical decision-making, we modified the pre-specified rescue criteria to a loss of more than 5 ETDRS letters in BCVA from baseline plus an increase in central subfield thickness, or CSFT, of 75-microns or more, replacing the previous rescue criteria that included a loss of 10 or more ETDRS letters in BCVA from baseline or a combination of worsening anatomical measures and BCVA loss. This change aligns the SOL-R trial more closely with how physicians determine when to intervene in the real world in the most conservative manner. This change was not an FDA requirement, but rather a strategic decision to further bridge the gap between clinical trial design and clinical practice. The primary endpoint is non-inferiority in mean change in BCVA from baseline between the AXPAXLI and on-label aflibercept 2 mg arms at Week 56. SOL-R remains robustly powered at 90% with the non-inferiority margin for the lower bound of -4.5 ETDRS letters of mean BCVA when compared to aflibercept 2 mg dosed every eight weeks, as per the protocol agreed to by the FDA.
Current wording
We are also conducting the SOL-R trial, a repeat-dosing registrational Phase 3 clinical trial to evaluate the non-inferiority of AXPAXLI 450 μg dosed every 24 weeks for the treatment of wet AMD compared to aflibercept 2 mg dosed on-label every eight weeks. The SOL-R trial includes sites located in the U.S., Argentina, India, and Australia. The SOL-R trial is designed as a multi-center, double-masked, randomized (2:2:1), three-arm trial and is intended to randomize approximately 555 subjects that are either treatment naïve or have been diagnosed with wet AMD in the study eye within about four months prior to enrollment. To qualify for screening in the SOL-R trial, a subject’s study eye must have a BCVA of at least 34 ETDRS letters (approximately 20/200 Snellen equivalent vision).
Previous wording
In a written Type C response received in August 2024, and a subsequent written response received in December 2024, the FDA agreed that the SOL-R repeat dosing wet AMD trial, with a primary endpoint at Week 56, should be appropriate as an adequate and well-controlled trial in support of a potential new drug application, or NDA, and product label for AXPAXLI for the treatment of wet AMD. The FDA also noted that the use of one superiority trial and one non-inferiority trial is generally acceptable as the basis of an eventual NDA in wet AMD.
Current wording
In a written Type C response received in August 2024, and a subsequent written response received in December 2024, the FDA agreed that the SOL-R repeat dosing wet AMD trial, with a primary endpoint at Week 56, should be appropriate as an adequate and well-controlled trial in support of a potential new drug application, or NDA, and for a product label for AXPAXLI for the treatment of wet AMD. The FDA also noted that the use of one superiority trial and one non-inferiority trial is generally acceptable as the basis of an eventual NDA in wet AMD.
Previous wording
If we obtain favorable results from the SOL-1 trial and the SOL-R trial, we plan to submit an NDA with the FDA for marketing approval of AXPAXLI for the treatment of wet AMD. Because axitinib is FDA-approved for non-ophthalmic indications, we plan to leverage the 505(b)(2) NDA review pathway which has the potential to shorten the review timeline for AXPAXLI by two months compared to the traditional review pathway for new molecular entities. If approved, we believe AXPAXLI has the potential to be the first product for wet AMD with a superiority label based on the SOL-1 trial, with redosing potentially as infrequently as every 12 months.
Current wording
If we obtain favorable results from the SOL-1 trial and the SOL-R trial, we plan to submit an NDA with the FDA for marketing approval of AXPAXLI for the treatment of wet AMD. Because axitinib is FDA-approved for non-ophthalmic indications, we plan to leverage the 505(b)(2) NDA review pathway which has the potential to shorten the review timeline for AXPAXLI by two months compared to the traditional review pathway for new molecular entities. If approved, we believe AXPAXLI has the potential to be the first product for wet AMD with a superiority label as compared to a single injection of anti-VEGF based on the SOL-1 trial, with redosing potentially as infrequently as every 12 months.
Previous wording
Our net product revenue was $13.4 million for the three months ended June 30, 2025, reflecting a decrease of $3.0 million or 18.3% over the three months ended June 30, 2024. Our net product revenue was $24.0 million for the six months ended June 30, 2025, reflecting a decrease of $7.1 million or 22.8% over the six months ended June 30, 2024.
Current wording
Our net product revenue was $14.5 million for the three months ended September 30, 2025, reflecting a decrease of $0.8 million or 5.2% over the three months ended September 30, 2024. Our net product revenue was $38.6 million for the nine months ended September 30, 2025, reflecting a decrease of $7.8 million or 16.8% over the nine months ended September 30, 2024.
Previous wording
We believe that the year-over-year decrease in net product revenue is primarily attributable to the impact of our pricing strategy, distributor stocking patterns, and buying patterns by ASCs, HOPDs and physicians’ offices. Further, the recent inclusion of DEXTENZA into the cost performance category of the Centers for Medicare & Medicaid Services’ Merit-based Incentive Payment System, or MIPS, for 2025 has negatively impacted demand for DEXTENZA.
Current wording
We believe that the year-over-year decrease in net product revenue is primarily attributable to the Medicare reimbursement cap, the impact of rebates and discounts, and the impact of the inclusion of DEXTENZA into the cost performance category of the Centers for Medicare & Medicaid Services’ Merit-based Incentive Payment System, or MIPS, for 2025.
Previous wording
Demand for DEXTENZA is determined by In-Market Sales, defined as unit sales from the SDs to ASCs, HOPDs, and physicians’ offices, and unit sales made directly by us to ASCs and physicians’ offices. We recorded In-Market Sales of approximately 44,000 units in the three months ended June 30, 2025, an increase of approximately 2,000 units compared to the three months ended June 30, 2024, and an increase of approximately 4,000 units compared to the three months ended March 31, 2025. Differences between In-Market Sales figures and the number of units of DEXTENZA sold by us to SDs and through Direct Sales as included in net product revenue recognized in our unaudited condensed consolidated financial statements are attributable to distributor stocking patterns. We believe that clinicians are starting to adjust to the impact of MIPS, and together with the effects of strong execution by our commercial team and our increased sales efforts directed towards HOPDs, which receive separate payment for DEXTENZA in 2025 after being ineligible for separate payments in 2024, we expect that demand for DEXTENZA continues to grow, as evidenced by sustained unit growth.
Current wording
Demand for DEXTENZA is determined by In-Market Sales, defined as unit sales from the SDs to ASCs, HOPDs, and physicians’ offices, and unit sales made directly by us to ASCs and physicians’ offices. We recorded In-Market Sales of approximately 48,000 units in the three months ended September 30, 2025, an increase of approximately 6,000 units compared to the three months ended September 30, 2024, and an increase of approximately 4,000 units compared to the three months ended June 30, 2025. Differences between In-Market Sales figures and the number of units of DEXTENZA sold by us to SDs and through Direct Sales as included in net product revenue recognized in our unaudited condensed consolidated financial statements are attributable to distributor stocking patterns. We believe that clinicians are adjusting to the impact of MIPS, and together with our increased sales efforts directed towards HOPDs, which receive separate payment for DEXTENZA in 2025 after being ineligible for separate payments in 2024, we expect DEXTENZA unit growth to continue.
Previous wording
The Trump administration has announced or imposed a series of tariffs on U.S. trading partners. In response, several countries have threatened or imposed retaliatory measures. At this time, we do not anticipate the tariffs and changes in trade policies in place as of the filing of this Quarterly Report on Form 10-Q will have a significant adverse effect on our business or operations.
Current wording
The Trump administration has announced or imposed a series of tariffs on U.S. trading partners. In response, several countries have threatened or imposed retaliatory measures. At this time, we do not anticipate the tariffs and changes in
Previous wording
Following recent changes more broadly within the FDA, we have not noticed any disruption in the cadence and nature of our dialogue with the FDA to date.
Current wording
Following recent changes more broadly within the FDA, and the more recent federal government shutdown, we have not noticed any disruption in the cadence and nature of our dialogue with the FDA to date.
Previous wording
On July 4, 2025, President Trump signed the One Big Beautiful Bill Act, or the OBBB, which includes, among other provisions, significant changes to healthcare policy. At this time, we do not anticipate the changes implemented by the OBBB to have a significant adverse effect on our business or operations.
Current wording
On July 4, 2025, President Trump signed the One Big Beautiful Bill Act, or the OBBBA, which includes, among other provisions, significant changes to healthcare policy. At this time, we do not anticipate the changes implemented by the OBBBA to have a significant adverse effect on our business or operations.
Previous wording
We record DEXTENZA product sales net of applicable off-invoice discounts, or OIDs, estimated chargebacks, rebates, distribution fees and product returns. Collectively, these discounts, allowances and other reserves are generally referred to as gross-to-net provisions, or GTN Provisions.
Current wording
We record DEXTENZA product sales net of applicable reserves for variable consideration, including off-invoice discounts, or OIDs, estimated chargebacks, rebates, distribution fees, product returns, and other incentives. Collectively, these discounts, allowances and other reserves are generally referred to as gross-to-net provisions, or GTN Provisions.
Previous wording
Any changes in the outcome of any of these variables with respect to the development of our product candidates in clinical and preclinical development could mean a significant change in the costs and timing associated with the development of these product candidates. For example, if the FDA or another regulatory authority were to require us to conduct clinical trials or other testing beyond those that we currently expect or if we experience significant delays in enrollment in any of our clinical trials, we could be required to expend significant additional financial resources and time
Current wording
Any changes in the outcome of any of these variables with respect to the development of our product candidates in clinical and preclinical development could mean a significant change in the costs and timing associated with the development of these product candidates. For example, if the FDA or another regulatory authority were to require us to conduct clinical trials or other testing beyond those that we currently expect or if we experience significant delays in enrollment in any of our clinical trials, we could be required to expend significant additional financial resources and time on the completion of clinical development of that product candidate. We anticipate that our research and development expenses will increase in the future as we support our continued development of our product candidates.
Previous wording
Interest Expense. Interest expense is incurred on our debt. In August 2023, we entered into a credit and security agreement, or the Barings Credit Agreement, with Barings Finance LLC, or Barings, as administrative agent, and the lenders party thereto, providing for a secured term loan facility, or the Barings Credit Facility, in the aggregate principal amount of $82.5 million. For the three and six months ended June 30, 2025, our interest-bearing debt included the Barings Credit Facility ($82.5 million outstanding principal). For the three months ended June 30, 2024, our interest-bearing debt included the Barings Credit Facility ($82.5 million outstanding principal). For the six months ended June 30, 2024, our interest-bearing debt included the Barings Credit Facility ($82.5 million outstanding principal) and our $37.5 million unsecured senior subordinated convertible notes, or the Convertible Notes ($37.5 million outstanding principal through March 28, 2024, no outstanding principal thereafter).
Current wording
Interest Expense. Interest expense is incurred on our debt. In August 2023, we entered into a credit and security agreement, or the Barings Credit Agreement, with Barings Finance LLC, or Barings, as administrative agent, and the lenders party thereto, providing for a secured term loan facility, or the Barings Credit Facility, in the aggregate principal amount of $82.5 million. For the three and nine months ended September 30, 2025, our interest-bearing debt included the Barings Credit Facility ($82.5 million outstanding principal). For the three months ended September 30, 2024, our interest-bearing debt included the Barings Credit Facility ($82.5 million outstanding principal). For the nine months ended September 30, 2024, our interest-bearing debt included the Barings Credit Facility ($82.5 million outstanding principal) and our $37.5 million unsecured senior subordinated convertible notes, or the Convertible Notes ($37.5 million outstanding principal through March 28, 2024, no outstanding principal thereafter).
Previous wording
Our product revenue, net was $13.4 million and $16.4 million for the three months ended June 30, 2025 and 2024, respectively, reflecting a decrease of $3.0 million year-over-year. All of our product revenue, net, was attributable to sales of DEXTENZA.
Current wording
Our product revenue, net was $14.5 million and $15.3 million for the three months ended September 30, 2025 and 2024, respectively, reflecting a decrease of $0.8 million year-over-year. All of our product revenue, net, was attributable to sales of DEXTENZA.
Previous wording
Our total GTN Provisions for the three months ended June 30, 2025 and 2024 were 51.7% and 39.6%, respectively, of gross DEXTENZA product sales. Effective July 1, 2025, we increased the OID for DEXTENZA as part of our overall pricing strategy. The OID amounts are generally determined at the time of resale by SDs or direct sales to ASCs or physicians’ offices by us. We are required to estimate the expected GTN Provisions when we sell DEXTENZA to SDs, ASCs and physicians’ offices and accrue for them at that time. The total GTN Provisions for the three months ended June 30, 2025 therefore include timing effects related to the increased OID, as units that we sold to SDs under the pre-July 2025 OID will be subject to the increased OID to the extent that such units are subsequently sold as In-Market Sales. The GTN Provisions relative to gross DEXTENZA product sales increased as a result of these changes and are expected to increase with any additional anticipated OID increases. We expect that GTN Provisions relative to gross DEXTENZA product sales will remain at this increased level, or might increase further, for the remainder of 2025 and beyond.
Current wording
Our total GTN Provisions for the three months ended September 30, 2025 and 2024 were 52.5% and 39.0%, respectively, of gross DEXTENZA product sales. We are required to estimate the expected GTN Provisions when we sell DEXTENZA to SDs, ASCs and physicians’ offices and accrue for them at that time. We adjust the OID, a significant component of the GTN Provisions for DEXTENZA from time to time and typically on a quarterly basis as part of our overall pricing strategy. The actual OID amounts are generally determined at the time of resale by SDs or direct sales to ASCs or physicians’ offices by us. Effective July 1, 2025, we increased the OID, and subsequently, effective October 1, 2025, we decreased the OID. The total GTN Provisions for the three months ended September 30, 2025 therefore include timing effects related to the decreased OID, as the estimated GTN Provisions for units that we sold to SDs during the three months ended September 30, 2025 under the pre-October 2025 OID and that were not sold as In-Market Sales during that period will be subject to the decreased OID. Compared to the three months ended September 30, 2024, the GTN Provisions relative to gross DEXTENZA product sales increased during the three months ended September 30, 2025, primarily as a result of the changes in the OID. We expect that GTN Provisions relative to gross DEXTENZA product sales will remain at this increased level, or might increase further, for the remainder of 2025 and beyond.
Previous wording
Within research and development expenses, expenses for clinical programs increased $36.7 million, unallocated expenses increased $8.6 million, and expenses for preclinical programs decreased $0.8 million.
Current wording
Within research and development expenses, expenses for clinical programs increased $17.8 million, unallocated expenses decreased $2.4 million, and expenses for preclinical programs decreased $0.1 million.
Previous wording
For the three months ended June 30, 2025, we incurred $34.1 million in direct research and development expenses for our products and product candidates compared to $15.0 million for the three months ended June 30, 2024. The increase of $19.1 million is related to timing and conduct of our various clinical trials for our product candidates, including the progression of the SOL-1 trial and the initiation and progression of the SOL-R trial.
Current wording
For the three months ended September 30, 2025, we incurred $35.9 million in direct research and development expenses for our products and product candidates compared to $18.2 million for the three months ended September 30, 2024. The increase of $17.7 million is related to timing and conduct of our various clinical trials for our product candidates, including the progression of the SOL-1 trial and the SOL-R trial.
Previous wording
We expect that direct research and development expenses for our products and product candidates will continue to increase significantly for the remainder of 2025 and beyond as we progress with the SOL-1 and the SOL-R trials; perform increased activities regarding the pre-commercial manufacturing of AXPAXLI; and initiate our planned long-term extension study for AXPAXLI for wet AMD and any other clinical trials of our product candidates that we may determine in the future to conduct. We expect that personnel costs will continue to increase for the remainder of 2025 and beyond.
Current wording
We expect that direct research and development expenses for our products and product candidates will continue to increase significantly for the remainder of 2025 and beyond as we progress with the SOL-1 and the SOL-R trials; initiate the planned SOL-X, HELIOS-2, and HELIOS-3 trials; and perform increased activities regarding the pre-commercial manufacturing of AXPAXLI. We expect that personnel costs will continue to increase for the remainder of 2025 and beyond as we plan to hire additional personnel to support our planned clinical trials.
Previous wording
The increase was primarily due to an increase in professional fees of $4.5 million, including costs related to our corporate branding; an increase in personnel-related costs, including stock-based compensation, of $2.7 million, including costs related to the expansion of our marketing team for AXPAXLI; and an increase in facility-related and other costs of $0.5 million.
Current wording
The increase is due to an increase in personnel-related costs, including stock-based compensation, of $1.4 million, primarily reflecting an increase related to the expansion of our marketing team for AXPAXLI; an increase in professional fees of $0.9 million, including costs related to our corporate branding; and an increase in facility-related and other costs of $0.2 million.
Previous wording
We expect our selling and marketing expenses to increase for the remainder of 2025 and beyond as we continue to support the commercialization of DEXTENZA and as we continue marketing-related activities regarding our corporate
Current wording
We expect our selling and marketing expenses to increase for the remainder of 2025 and beyond as we continue to support the commercialization of DEXTENZA and initiate and continue marketing-related activities in connection with the potential commercial launch of AXPAXLI.
Previous wording
We anticipate that our general and administrative expenses will increase for the remainder of 2025 and beyond, as we continue to further strengthen certain functions that support our clinical trials of AXPAXLI, including the SOL-1 trial and the SOL-R trial, and our business in general.
Current wording
We anticipate that our general and administrative expenses will increase for the remainder of 2025 and beyond, as we continue to further strengthen certain functions and processes that support our clinical trials of AXPAXLI, including the SOL-1 trial, the SOL-R trial, and our planned SOL-X, HELIOS-2, and HELIOS-3 trials.
Previous wording
Interest Income. Interest income was $3.5 million and $6.0 million for the three months ended June 30, 2025 and 2024, respectively, reflecting a decrease of $2.5 million year-over-year. The decrease is attributable primarily to a lower average balance of interest-generating cash and cash equivalents.
Current wording
Interest Income. Interest income was $3.7 million and $5.7 million for the three months ended September 30, 2025 and 2024, respectively, reflecting a decrease of $2.0 million year-over-year. The decrease is attributable primarily to a lower average balance of interest-generating cash and cash equivalents.
Previous wording
*Change in Fair Value of Derivative Liabilities.*We recognized a net loss from the change in fair values of our derivative liabilities of $1.6 million and $8.2 million for the six months ended June 30, 2025 and 2024, respectively. The net loss for the six months ended June 30, 2025 is comprised of a loss of $0.8 million from the change in the fair value of the derivative liability related to the Barings Credit Agreement, and an expense of $0.8 million related to royalty fees under the Barings Credit Agreement that we paid or accrued. The net loss for the six months ended June 30, 2024 is comprised of a loss of $9.7 million from the change in the fair value of the derivative liability related to the Barings Credit Agreement, and $1.1 million related to royalty fees under the Barings Credit Agreement that we paid or accrued, partially offset by a gain of $2.6 million from the change in the fair value of the derivative liability related to a conversion option embedded in the Convertible Notes. We cannot predict how the fair value of the derivative liability related to the Barings Credit Agreement will change in the remainder of 2025 and beyond.
Current wording
*Change in Fair Value of Derivative Liabilities.*We recognized a net loss from the change in fair value of our derivative liability related to the Barings Credit Agreement of $1.4 million for the three months ended September 30, 2025. We recognized a net gain from the change in fair value of our derivative liability related to the Barings Credit Agreement of $7.1 million for the three months ended September 30, 2024. The net loss for the three months ended September 30, 2025 is comprised of a non-cash loss of $0.9 million from the change in the fair value of the derivative liability, and an expense of $0.5 million related to royalty fees under the Barings Credit Agreement that we paid or accrued. The net gain for the three months ended September 30, 2024 is comprised of a non-cash gain of $7.6 million from the change in the fair value of the derivative liability, partially offset by a $0.5 million expense related to royalty fees under the Barings Credit Agreement that we paid or accrued. We cannot predict how the fair value of the derivative liability related to the Barings Credit Agreement will change in the remainder of 2025 and beyond.
Previous wording
The following table summarizes our results of operations for the six months ended June 30, 2025 and 2024:
Current wording
The following table summarizes our results of operations for the nine months ended September 30, 2025 and 2024:
Previous wording
Our product revenue, net was $24.0 million and $31.1 million for the six months ended June 30, 2025 and 2024, respectively, reflecting a decrease of $7.1 million year-over-year. All of our product revenue, net, was attributable to sales of DEXTENZA.
Current wording
Our product revenue, net was $38.6 million and $46.4 million for the nine months ended September 30, 2025 and 2024, respectively, reflecting a decrease of $7.8 million year-over-year. All of our product revenue, net, was attributable to sales of DEXTENZA.
Previous wording
Our total GTN Provisions for the six months ended June 30, 2025 and 2024 were 50.7% and 38.0%, respectively, of gross DEXTENZA product sales. Effective April 1, 2025, we increased the wholesale acquisition cost, or WAC, and we concurrently increased the OID for DEXTENZA as part of our overall pricing strategy. Subsequently, effective July 1, 2025, we increased the OID further. The OID amounts are generally determined at the time of resale by SDs or direct sales to ASCs or physicians’ offices by us. We are required to estimate the expected GTN Provisions when we sell DEXTENZA to SDs, ASCs and physicians’ offices and accrue for them at that time. The total GTN Provisions for the six months ended June 30, 2025 therefore include timing effects related to the increased WAC and OID, as units that we sold to SDs under the pre-April 2025 WAC and OID will be subject to the increased WAC and OID, and units that we sold to SDs under the pre-July OID will be subject to the increased OID, to the extent that such units are subsequently sold as In-Market Sales. The GTN Provisions relative to gross DEXTENZA product sales increased as a result of these changes and are expected to increase with any additional anticipated OID increases. We expect that GTN Provisions relative to gross DEXTENZA product sales will remain at this increased level, or might increase further, for the remainder of 2025 and beyond.
Current wording
Our total GTN Provisions for the nine months ended September 30, 2025 and 2024 were 51.4% and 38.3%, respectively, of gross DEXTENZA product sales. We are required to estimate the expected GTN Provisions when we sell DEXTENZA to SDs, ASCs and physicians’ offices and accrue for them at that time. We adjust the OID, a significant component of the GTN Provisions for DEXTENZA from time to time and typically on a quarterly basis as part of our overall pricing strategy. The actual OID amounts are generally determined at the time of resale by SDs or direct sales to ASCs or physicians’ offices by us. Effective April 1, 2025, we increased the wholesale acquisition cost, or WAC, and we concurrently increased the OID for DEXTENZA as part of our overall pricing strategy. Subsequently, effective July 1, 2025, we increased the OID further. Effective October 1, 2025, we decreased the OID. The total GTN Provisions for the nine months ended September 30, 2025 therefore include timing effects related to the increased WAC and the changes to the OID, as the estimated GTN Provisions for units that we sold to SDs during the three months ended September 30, 2025 under the pre-October 2025 OID and that were not sold as In-Market Sales during that period will be subject to the decreased OID. Compared to the nine months ended September 30, 2025, the GTN Provisions relative to gross DEXTENZA product sales increased during the nine months ended September 30, 2025, primarily as a result of these changes. We expect that GTN Provisions relative to gross DEXTENZA product sales will remain at this increased level, or might increase further, for the remainder of 2025 and beyond.
Previous wording
Our collaboration revenue was $0.1 million and $0.1 million for the six months ended June 30, 2025 and 2024, respectively. All of our collaboration revenue was attributable to the performance obligation under our license agreement with AffaMed to conduct a Phase 2 clinical trial of OTX-TIC. We recognize collaboration revenue based on a cost-to-cost method. We do not expect to recognize additional collaboration revenue for the remainder of 2025, as we have substantially satisfied the performance obligation.
Current wording
Our collaboration revenue was $0.1 million and $0.2 million for the nine months ended September 30, 2025 and 2024, respectively. All of our collaboration revenue was attributable to the performance obligation under our license agreement with AffaMed to conduct a Phase 2 clinical trial of OTX-TIC. We recognize collaboration revenue based on a
Previous wording
During the three months ended June 30, 2025, we recognized $0.1 million of collaboration revenue related to the performance obligation under our license agreement with AffaMed to conduct a Phase 2 clinical trial of OTX-TIC, compared to $0.1 million in the three months ended June 30, 2024. We recognize collaboration revenue based on a cost-to-cost method. We do not expect to recognize additional collaboration revenue for the remainder of 2025, as we have substantially satisfied the performance obligation.
Current wording
cost-to-cost method. We do not expect to recognize additional collaboration revenue for the remainder of 2025, as we have fully satisfied the performance obligation.
Previous wording
Within research and development expenses, expenses for clinical programs increased $19.4 million, unallocated expenses increased $3.1 million, and expenses for preclinical programs decreased $0.3 million.
Current wording
Within research and development expenses, expenses for clinical programs increased $55.1 million, unallocated expenses increased $5.5 million, and expenses for preclinical programs decreased $0.9 million.
Previous wording
For the six months ended June 30, 2025, we incurred $59.6 million in direct research and development expenses for our products and product candidates compared to $23.7 million for the six months ended June 30, 2024. The increase of $35.9 million is related to timing and conduct of our various clinical trials for our product candidates, including the progression of the SOL-1 trial, the initiation and progression of the SOL-R trial, and the completion of the HELIOS trial.
Current wording
For the nine months ended September 30, 2025, we incurred $96.2 million in direct research and development expenses for our products and product candidates compared to $42.0 million for the nine months ended September 30, 2024. The increase of $54.2 million is related to timing and conduct of our various clinical trials for our product candidates, including the progression of the SOL-1 trial, the initiation and progression of the SOL-R trial, and the completion of the HELIOS-1 trial.
Previous wording
We expect that direct research and development expenses for our products and product candidates will continue to increase significantly for the remainder of 2025 and beyond as we progress with the SOL-1 and the SOL-R trials; perform increased activities regarding the pre-commercial manufacturing of AXPAXLI; and initiate our planned long-term extension study for AXPAXLI for wet AMD and any other clinical trials of our product candidates that we may determine in the future to conduct. We expect that personnel costs will continue to increase for the remainder of 2025 and beyond.
Current wording
We expect that direct research and development expenses for our products and product candidates will continue to increase significantly for the remainder of 2025 and beyond as we progress with the SOL-1 and the SOL-R trials; initiate the planned SOL-X, HELIOS-2, and HELIOS-3 trials; and perform increased activities regarding the pre-commercial manufacturing of AXPAXLI. We expect that personnel costs will continue to increase for the remainder of 2025 and beyond as we plan to hire additional personnel to support our planned clinical trials.
Previous wording
The increase was primarily due to an increase in professional fees of $2.2 million, including costs related to our corporate branding; an increase in personnel-related costs, including stock-based compensation, of $1.3 million, including costs related to the expansion of our marketing team for AXPAXLI; and an increase in facility-related and other costs of $0.2 million.
Current wording
The increase was primarily due to an increase in professional fees of $5.4 million, including costs related to our corporate branding; an increase in personnel-related costs, including stock-based compensation, of $4.1 million, including costs related to the expansion of our marketing team for AXPAXLI; and an increase in facility-related and other costs of $0.7 million.
Previous wording
The decrease was primarily due to a decrease in personnel-related costs, including stock-based compensation, of $5.2 million and a decrease in professional fees of $0.5 million, partially offset by an increase in facility-related and other costs of $0.4 million. In the three months ended June 30, 2024, we executed and substantially completed a strategic reduction in force as part of an initiative to prioritize our resources on the clinical development of AXPAXLI for wet AMD, or the Strategic Restructuring. Personnel-related costs, including stock-based compensation, for the three months ended June 30, 2024 include $1.6 million related to accrued wages, severance, and other benefits under the Strategic Restructuring, and $7.1 million related to accrued severance and acceleration of stock-based compensation for certain employees who departed during the three months ended June 30, 2024 separate from the Strategic Restructuring, including our former Chief Executive Officer and our former Chief Medical Officer.
Current wording
The increase was primarily due to an increase in facility-related and other costs of $1.9 million and an increase in personnel-related costs, including stock-based compensation, of $0.5 million, partially offset by a decrease in professional fees of $1.7 million. Personnel-related costs, including stock-based compensation, for the nine months ended September 30, 2025 include $1.5 million related to acceleration of stock-based compensation for former executives. In the nine months ended September 30, 2024, we executed and substantially completed a strategic reduction in force as part of an initiative to prioritize our resources on the clinical development of AXPAXLI for wet AMD, or the Strategic Restructuring. Personnel-related costs, including stock-based compensation, for the nine months ended September 30, 2024 include $1.6 million related to wages, severance, and other benefits under the Strategic Restructuring, and $9.9 million related to accrued severance and acceleration of stock-based compensation for certain employees who departed during the nine months ended September 30, 2024 separate from the Strategic Restructuring, including our former Chief Executive Officer, our former Chief Business Officer, and our former Chief Medical Officer.
Previous wording
We anticipate that our general and administrative expenses will increase for the remainder of 2025 and beyond, as we continue to further strengthen certain functions that support our clinical trials of AXPAXLI, including the SOL-1 trial and the SOL-R trial, and our business in general.
Current wording
We anticipate that our general and administrative expenses will increase for the remainder of 2025 and beyond, as we continue to further strengthen certain functions and processes that support our clinical trials of AXPAXLI, including the SOL-1 trial, the SOL-R trial, and our planned SOL-X, HELIOS-2, and HELIOS-3 trials.
Previous wording
Interest Income. Interest income was $7.3 million and $10.0 million for the six months ended June 30, 2025 and 2024, respectively, reflecting a decrease of $2.7 million year-over-year. The decrease is attributable primarily to a lower average balance of interest-generating cash and cash equivalents.
Current wording
Interest Income. Interest income was $11.0 million and $15.6 million for the nine months ended September 30, 2025 and 2024, respectively, reflecting a decrease of $4.6 million year-over-year. The decrease is attributable primarily to a lower average balance of interest-generating cash and cash equivalents.
Previous wording
Interest Expense. Interest expense was $6.0 million and $7.2 million for the six months ended June 30, 2025 and 2024, respectively, reflecting a decrease of $1.2 million year-over-year. The decrease is primarily due to lower average balances of debt outstanding as a result of the conversion of the Convertible Notes in March 2024.
Current wording
Interest Expense. Interest expense was $9.0 million and $10.5 million for the nine months ended September 30, 2025 and 2024, respectively, reflecting a decrease of $1.5 million year-over-year. The decrease is primarily due to lower average balances of debt outstanding as a result of the conversion of the Convertible Notes in March 2024.
Previous wording
*Change in Fair Value of Derivative Liabilities.*We recognized a net loss from the change in fair values of our derivative liability related to the Barings Credit Agreement of $0.6 million and $3.0 million for the three months ended June 30, 2025 and 2024, respectively. The net loss for the three months ended June 30, 2025 is comprised of a loss of $0.2 million from the change in the fair value of the derivative liability, and an expense of $0.5 million related to royalty fees under the Barings Credit Agreement that we paid or accrued. The net loss for the three months ended June 30, 2024 is comprised of a loss of $2.5 million from the change in the fair value of the derivative liability, and an expense of $0.6 million related to royalty fees under the Barings Credit Agreement that we paid or accrued. We cannot predict how the fair value of the derivative liability related to the Barings Credit Agreement will change in the remainder of 2025 and beyond.
Current wording
*Change in Fair Value of Derivative Liabilities.*We recognized a net loss from the change in fair values of our derivative liabilities of $3.1 million and $1.1 million for the nine months ended September 30, 2025 and 2024, respectively. The net loss for the nine months ended September 30, 2025 is comprised of a non-cash loss of $1.7 million from the change in the fair value of the derivative liability related to the Barings Credit Agreement, and an expense of $1.4 million related to royalty fees under the Barings Credit Agreement that we paid or accrued. The net loss for the nine months ended September 30, 2024 is comprised of a non-cash loss of $2.1 million from the change in the fair value of
Showing the first 40 of 52 pairs. Open the source sections for the rest.
Rearranged current paragraphs (6)
Current report — wording carried from elsewhere
trade policies in place as of the filing of this Quarterly Report on Form 10-Q will have a significant adverse effect on our business or operations.
Current report — wording carried from elsewhere
the derivative liability related to the Barings Credit Agreement, and an expense of $1.6 million related to royalty fees under the Barings Credit Agreement that we paid or accrued, partially offset by a gain of $2.6 million from the change in the fair value of the derivative liability related to a conversion option embedded in the Convertible Notes. We cannot predict how the fair value of the derivative liability related to the Barings Credit Agreement will change in the remainder of 2025 and beyond.
Current report — wording carried from elsewhere
if approved. We have based our estimates on assumptions that may prove to be wrong, and we could use our capital resources sooner than we currently expect.
Current report — wording carried from elsewhere
Until such time, if ever, as we can generate product revenues sufficient to achieve profitability, we expect to finance our cash needs through equity offerings, debt financings, collaborations, strategic alliances, licensing arrangements, royalty agreements, and marketing and distribution arrangements. We do not have any committed external source of funds, although our license agreement with AffaMed provides for AffaMed’s reimbursement of certain clinical expenses incurred by us in connection with our collaboration and for our potential receipt of development and sales milestone payments and royalty payments. To the extent that we raise additional capital through the sale of equity, preferred equity or convertible debt securities, our securityholders’ ownership interests will be diluted, and the terms of these securities may include liquidation or other preferences that adversely affect our existing securityholders’ rights as
Current report — wording carried from elsewhere
Net cash used by net unfavorable changes in our operating assets and liabilities during the nine months ended September 30, 2024 consisted primarily of net increases of prepaid expenses and other current assets, resulting primarily from our clinical development activities, of $5.4 million, net increases of accounts receivable, net, of $4.1 million, and other changes, net, of $1.7 million. Other changes, net, include a $11.4 million payment of interest to the holder of the Convertible Notes in March 2024.
Current report — wording carried from elsewhere
Investing activities. Net cash used in investing activities was $9.0 million for the nine months ended September 30, 2025, consisting of cash used to purchase property and equipment and leasehold improvements of $9.2
Rearranged previous paragraphs (3)
Previous report — wording carried elsewhere
on the completion of clinical development of that product candidate. We anticipate that our research and development expenses will increase in the future as we support our continued development of our product candidates.
Previous report — wording carried elsewhere
branding and initiate and continue marketing-related activities in connection with the potential commercial launch of AXPAXLI.
Previous report — wording carried elsewhere
The decrease was primarily due to a decrease in personnel-related costs, including stock-based compensation, of $4.0 million and a decrease in professional fees of $0.8 million, partially offset by an increase in facility-related and other costs of $1.6 million. Personnel-related costs, including stock-based compensation, for the six months ended June 30, 2025 include $1.5 million related to acceleration of stock-based compensation for former executives. Personnel-related costs, including stock-based compensation, for the six months ended June 30, 2024 include $1.6 million related to accrued wages, severance, and other benefits under the Strategic Restructuring and $9.9 million related to accrued severance and acceleration of stock-based compensation for certain employees who departed during the six months ended June 30, 2024 separate from the Strategic Restructuring, including our former Chief Executive Officer, our former Chief Business Officer, and our former Chief Medical Officer.