{"success":true,"data":{"pressRelease":{"id":"106046","rtpr_id":"nGNX3XnDBc","ticker":"OCUL","exchange":"NASDAQ","all_tickers":["OCUL"],"title":"Ocular Therapeutix™ Reports Second Quarter 2026 Financial Results and Business Highlights","author":"Globe Newswire","published_at":"2026-08-03T11:00:00.880Z","article_body":"Ocular’s AXPAXLI(TM) wet AMD NDA submission on track for Q4 2026 following\npositive Type C Meeting with the U.S. FDA in May 2026\n\nFDA Type C Meeting Minutes Formalize SOL-1 Trial with Confirmatory Evidence as\nSufficient to Support Submission of AXPAXLI NDA in wet AMD\n\nAXPAXLI NDA submission to be based on SOL-1 Week 52 efficacy and safety data,\ninterim SOL-R safety data, and confirmatory evidence\n\nPre-NDA meeting scheduled with FDA in Q3 2026 with the NDA submission to\nfollow the Section 505(b)(2) pathway which could accelerate the review\ntimeline by up to 60 days\n\nNew Post Hoc SOL-1 analysis demonstrates up to an estimated 72% reduction in\ntreatment burden over 60 weeks with AXPAXLI as compared to a projected\non-label aflibercept (2 mg) dosing schedule of every 8 weeks\n\nCommercial readiness accelerating ahead of a potential 2027 launch\n\nCash balance of $598.6 million as of June 30, 2026, with expected runway into\n2028\n\nBEDFORD, Mass., Aug. 03, 2026 (GLOBE NEWSWIRE) -- Ocular Therapeutix, Inc.\n(NASDAQ: OCUL, “Ocular”), an integrated biopharmaceutical company\ncommitted to redefining the retina experience, today reported financial\nresults for the second quarter ended June 30, 2026, and provided recent\nbusiness highlights focused on its NDA submission plan and further clinical\ndevelopment for AXPAXLI (also known as OTX-TKI). The Company will not be\nhosting a second quarter 2026 conference call following its recent investor\nday in June. The Company plans to resume quarterly earnings calls for its\nthird quarter 2026 financial results.\n\n“We continue to execute with discipline, precision, and urgency to redefine\nthe retina experience and make AXPAXLI available to patients as early as\npossible. Our June Investor Day marked a pivotal milestone with the\nannouncement of a clear, FDA-aligned path to submit the AXPAXLI NDA for wet\nAMD in the fourth quarter of 2026,” said Pravin U. Dugel, MD, Executive\nChairman, President and CEO of Ocular Therapeutix. “This approach is\ndesigned to support the fastest risk-mitigated path to NDA submission and\nreview. Consistent with the FDA Type C meeting minutes, the AXPAXLI NDA\nsubmission will be based on SOL-1 efficacy and safety data, interim safety\ndata from SOL-R and supporting confirmatory evidence, including axitinib’s\nestablished profile as a VEGFR inhibitor from more than a decade of clinical\nuse since FDA approval for renal cell carcinoma. By pursuing the 505(b)(2)\nregulatory pathway, we believe the AXPAXLI NDA submission is strongly\npositioned to benefit from a review timeline up to 60 days shorter than the\ntypical new molecular entity.”\n\nPeter K. Kaiser, MD, Chief Development Officer of Ocular Therapeutix added,\n“SOL-1 is the first and only successful superiority trial of a novel agent\nagainst an approved anti-VEGF therapy since the class emerged two decades ago.\nToday, up to 40% of wet AMD patients discontinue therapy within the first year\nalone, largely attributable to the treatment burden and its impact on patients\nand caregivers. In a new post-hoc analysis of SOL-1 data applying the SOL-R\nrescue criteria of >5 ETDRS letter loss and ≥75 µm CSFT increase from\nbaseline, we estimate a treatment burden reduction of up to 72% as compared to\na projected on-label dosing regimen of aflibercept (2 mg) over 60 weeks. The\nrobust potential of AXPAXLI to reduce treatment burden in the real-world may\nimprove adherence and long-term outcomes for our patients.”\n\n Estimated Reduction in Treatment Burden Excluding Loading Doses \n Mean Number of Expected Injections Per Subject* AXPAXLI aflibercept (2 mg) Injection Burden Reduction \n From Week -8 to Week 52 1.95 7.00 72 % \n\n\n\n Estimated Reduction in Treatment Burden Including Loading Doses \n Mean Number of Expected Injections Per Subject* AXPAXLI aflibercept (2 mg) Injection Burden Reduction \n From Week -8 to Week 52 3.95 9.00 56 % \n\n*Methodology outlined below in “Recent Achievements and Upcoming\nMilestones”\n\nRecent Achievements and Upcoming Milestones:\n* New Drug Application (NDA) submission for AXPAXLI in wet AMD planned for Q4\n2026, with FDA alignment confirmed in May 2026 Type C meeting minutes. The NDA\nsubmission will be based on SOL-1 efficacy and safety data, an interim SOL-R\nsafety analysis of patients who have reached Week 52 to be conducted in the\nfourth quarter of 2026, and confirmatory evidence. Together with the existing\nSOL-1 safety database, this interim SOL-R safety analysis will bring the\naggregate safety dataset to more than 300 patients with at least one year of\nAXPAXLI safety data and in-line with FDA requirements. A pre-NDA meeting with\nthe FDA is scheduled for the third quarter of 2026. Ocular intends to submit\nthe NDA under the 505(b)(2) pathway, which could accelerate the review\ntimeline by up to 60 days.\n* Post-hoc Analysis of SOL-1 (Phase 3, wet AMD) demonstrates up to an\nestimated 72% reduction in treatment burden over 60 weeks with AXPAXLI\nrelative to a projected on-label dosing regimen of aflibercept (2 mg) every 8\nweeks. The proportion of SOL-1 patients who would have remained rescue-free\nunder the SOL-R rescue criteria of >5 ETDRS letter loss and ≥75 µm CSFT\nincrease from baseline was 66.5% at Week 52. Applying the observed mean rescue\ntreatment rates in SOL-1 to the estimated 33.5% of subjects requiring rescue\nunder the SOL-R criteria corresponded to an average of 0.95 aflibercept (2 mg)\nrescues per subject for all subjects in the AXPAXLI arm through Week 52 after\na single AXPAXLI injection at baseline. The total estimated mean injection\nburden with AXPAXLI represents a 72% reduction counting from the first\nscreening visit at Week -8 excluding loading doses and a 56% reduction when\nloading doses are included, as compared to a projected on-label dosing regimen\nof aflibercept (2 mg) with no rescues.\n* SOL-R (Phase 3, wet AMD) to be amended to maximize AXPAXLI label potential\nfollowing robust SOL-1 results and confirmation from FDA that SOL-R efficacy\ndata is not required for the AXPAXLI NDA submission. With superiority\ndemonstrated at Weeks 36 and 52 against a single injection of aflibercept (2\nmg) in SOL-1, Ocular now plans to evaluate a new key secondary endpoint of\nsuperiority to aflibercept (8 mg) at Week 96 in SOL-R. Another secondary\nendpoint will evaluate prevention of fibrosis and atrophy relative to\naflibercept (2 mg) at Week 96. To facilitate these evaluations, Ocular will\nextend the efficacy analysis and sponsor-masking in SOL-R until the end of\nstudy at Week 96. These outcomes, if positive, have the potential to establish\nAXPAXLI as a best-in-disease agent in wet AMD. Following these changes,\ntopline SOL-R results are now expected in the first quarter of 2028. The\ntrial's primary endpoint, non-inferiority of AXPAXLI to aflibercept (2 mg) at\nWeek 56, remains unchanged.\n* SOL-X (wet AMD) enrollment continues to accelerate, with the vast majority\nof trial investigators and eligible patients opting to participate in the\nopen-label extension study. Subjects who have completed their two-year\nfollow-up in either the SOL-1 or SOL-R trials are eligible to enroll in the\nthree-year open-label extension study evaluating the long-term safety and\noutcomes of AXPAXLI dosed every 24 weeks. Ocular believes sustained VEGF\nsuppression with AXPAXLI may reduce the incidence of fibrosis and atrophy in\nwet AMD, thereby improving long-term outcomes. The first subject enrolled in\nSOL-X in April 2026.\n* Diabetic retinopathy program streamlined to prioritize HELIOS-3 (Phase 3,\nNPDR) as Ocular's potential single registrational trial. HELIOS-3 will now\nevaluate AXPAXLI dosed every 12 months (Q48W) versus sham with the trial size\nbeing reduced from 930 to 620 patients. The decision to amend the HELIOS-3\ndesign was based on AXPAXLI’s observed durability of up to 12 months in\nSOL-1, HELIOS-1 data, and market research showing physician preference for\nonce-yearly dosing. HELIOS-3 is designed to support a broad label in diabetic\nretinal disease, including patients with diabetic macular edema (DME).\n* Commercial readiness activities, including market and payer research,\nadvancing rapidly ahead of a potential 2027 launch of AXPAXLI, if approved.\nFollowing SOL-1's results, market research found that approximately 80% of\nretina specialists surveyed would likely use a product with AXPAXLI’s\nprofile based on SOL-1 data alone, with more than 90% expected to adopt such a\nproduct within its first year, if approved. Physicians cited disease control,\npredictable dosing interval, and seamless fit within existing workflows as key\ndrivers of anticipated use. Ocular's payer team has also engaged 100% of Tier\n1 Medicare Advantage and commercial payers, who have indicated that a label\ndemonstrating superior durability could command premium pricing.\n                                      \nSecond Quarter Ended June 30, 2026, Financial Results:\n\nTotal cash and cash equivalents were $598.6 million as of June 30, 2026. Based\non current plans and related estimates of anticipated cash inflows from\nDEXTENZA(®), the Company believes that its current cash balance is sufficient\nto support its planned operating expenses, debt service obligations, and\ncapital expenditure requirements into 2028.\n\nThis cash projection factors in the completion of the SOL-1 trial and the\ncontinued execution of the SOL-R, the SOL-X and the HELIOS-3 trials. The\nprojection also includes investment in pre-commercial activities and\npreparations for the potential FDA approval and initial launch of AXPAXLI but\ndoes not currently include the full expenses the Company anticipates it needs\nto support the near-term commercialization of AXPAXLI, if approved.\n\nTotal net revenue was $13.5 million for the second quarter of 2026, flat as\ncompared to the comparable quarter of 2025. Total net revenue includes both\ngross DEXTENZA product revenue, net of discounts, rebates, and returns, which\nincreased $0.1 million or 0.6% over Q2 2025, and collaboration revenue, which\nwas $0.0 million in Q2 2026 versus $0.1 million in Q2 2025.\n\nResearch and development expenses for the second quarter of 2026 were $54.1\nmillion versus $51.1 million for the comparable quarter in 2025, reflecting an\nincrease in overall clinical expenses associated with the ongoing SOL-1,\nSOL-R, SOL-X and HELIOS-3 clinical trials, with additional personnel and\nprofessional services to support these clinical trials and preparations to\nsubmit the planned NDA for AXPAXLI in wet AMD.\n\nSelling and marketing expenses were $17.3 million for the second quarter of\n2026, as compared to $13.7 million for the comparable quarter of 2025,\nreflecting an increase in personnel-related costs, including stock-based\ncompensation expense, related to the expansion of our commercial team and\npre-commercial investments to support a potential AXPAXLI launch.\n\nGeneral and administrative expenses were $22.2 million for the second quarter\nof 2026, as compared to $14.3 million for the comparable quarter of 2025,\nreflecting an increase in personnel-related costs, including stock-based\ncompensation expense, professional fees and facility-related costs.\n\nNet loss for the second quarter of 2026 was $(78.8) million, or a net loss\nof $(0.35) per share on both a basic and diluted basis, compared to a net\nloss of $(67.8) million, or a net loss of $(0.39) per share on a basic and\ndiluted basis, for the comparable quarter of 2025.\n\nOutstanding shares as of July 31, 2026, were approximately 225.0 million.\n\nAbout AXPAXLI\nAXPAXLI™ (also known as OTX-TKI) is an investigational, bioresorbable,\nintravitreal hydrogel incorporating axitinib, a small molecule, multi-target,\ntyrosine kinase inhibitor with anti-angiogenic properties, being evaluated for\nthe treatment of wet AMD and diabetic retinal disease.\n\nAbout the SOL-1 Trial\nThe registrational Phase 3 SOL-1 trial (NCT06223958) is designed to evaluate\nthe safety and efficacy of AXPAXLI in a multi-center, double-masked,\nrandomized (1:1), parallel group trial that involves more than 100 clinical\ntrial sites located in the U.S. and Argentina. In December 2024, the trial\ncompleted randomization of 344 treatment-naïve subjects with a diagnosis of\nwet AMD in the study eye. Two randomized subjects withdrew from the trial\nprior to receiving Day 1 treatment.\n\nThe superiority trial has an eight-week loading segment prior to\nrandomization. During the loading segment, subjects who have 20/80 vision or\nbetter and a central subfield thickness (CSFT) of ≤500 μm receive two doses\nof aflibercept (2 mg) at Week -8 and Week -4. Subjects who achieve best\ncorrected visual acuity (BCVA) of 20/20 at Day 1 (baseline) or gain at least\n10 Early Treatment Diabetic Retinopathy Study (ETDRS) letters at Day 1 along\nwith a CSFT of ≤350 μm were then randomized to receive a single dose of\nAXPAXLI (0.45 mg) or a single dose of aflibercept (2 mg). At Week 52 and at\nWeek 76, all subjects are re-dosed with their respective initial treatment of\nAXPAXLI (0.45 mg) or aflibercept (2 mg). Subjects will be followed for safety\nuntil the end of Week 104.\n\nThroughout the trial, subjects are assessed monthly. Trial subjects and\ndesignated trial personnel will remain masked through the end of Week 104. The\nclinical trial protocol requires that, during the trial, subjects in either\narm meeting the pre-specified rescue criteria, which include a BCVA loss of\n≥15 ETDRS letters from baseline or new vision-threatening macular\nhemorrhage, will receive a supplemental dose of aflibercept (2 mg). The\nprotocol provides that after the first rescue injection, rescue therapy may be\nprovided at investigator discretion per their clinical judgement.\n\nThe primary endpoint of SOL-1 is the proportion of subjects who maintain\nvisual acuity, defined as a loss of <15 ETDRS letters of BCVA from baseline,\nat Week 36. Predefined statistical rules were applied to adjust for treatment\ndiscontinuation or deviation as per the pre-specified statistical analysis\nplan. The trial remained masked following Week 36 and subjects were evaluated\nfor treatment durability at Week 52. The trial is being conducted under a\nSpecial Protocol Assessment (SPA) agreement with the FDA.\n\nIn February 2026, Ocular reported positive SOL-1 Week 52 topline data. The\nsuperiority primary endpoint was met with 74.1% of subjects in the AXPAXLI\n(0.45 mg) arm maintaining vision at Week 36, a 17.5% risk difference\n(p=0.0006), compared to the aflibercept (2 mg) arm. A key secondary endpoint\nwas met with 65.9% of subjects treated with AXPAXLI (0.45 mg) maintaining\nvision at Week 52, a 21.1% risk difference (p<0.0001), compared to the\naflibercept (2 mg) arm.\n\nAbout the SOL-R Trial\nThe registrational Phase 3 SOL-R trial (NCT06495918) is designed to evaluate\nthe safety and efficacy of AXPAXLI in a multi-center, double-masked,\nrandomized (2:2:1), three-arm trial that includes sites located in the U.S.,\nArgentina, India, and Australia in subjects who are treatment-naïve or were\ndiagnosed with wet AMD in the study eye within about four months prior to\nenrollment. Further, to qualify for screening, a subject’s study eye must\nhave had a BCVA ETDRS letter score of ≥34 (~20/200). In December 2025, the\ntrial completed the randomization of 640 subjects.\n\nThis non-inferiority trial reflects a patient enrichment strategy over the six\nmonths prior to randomization that includes three screening doses of any\nanti-VEGF therapy, excluding brolucizumab-dbll, and monitoring to exclude\nthose subjects with early persistent fluid or significant retinal fluid\nfluctuations. Subjects who continue to meet eligibility, defined as a CSFT of\n≤350 μm at Week -12 and Week –8, with ≤35 μm CSFT increase at Week -8\nfrom the lowest CSFT at any prior visit, entered a run-in period and received\ntwo loading doses of aflibercept (2 mg) prior to Day 1. Subjects in the first\narm receive a single dose of AXPAXLI (0.45 mg) at Day 1 and are re-dosed at\nWeeks 24, 48, and 72. Subjects in the second arm receive aflibercept (2 mg) on\nDay 1 and per label every eight weeks thereafter. Subjects in the third arm\nreceive a single dose of aflibercept (8 mg) at Day 1 and are re-dosed at Weeks\n24, 48, and 72, aligned with the AXPAXLI treatment arm for adequate masking.\nSubjects will be followed for safety until the end of Week 96. Throughout the\ntrial, subjects are assessed monthly. Trial subjects and designated trial\npersonnel will remain masked through the end of Week 96. Subjects in any arm\nthat meet pre-specified rescue criteria will receive a supplemental dose of\naflibercept (2 mg). The pre-specified rescue criteria include a >5-letter loss\nin visual acuity plus a ≥75 μm increase in CSFT.\n\nThe primary endpoint of SOL-R is to demonstrate non-inferiority in mean BCVA\nchange from baseline between the AXPAXLI and on-label aflibercept (2 mg) arms\nat Week 56. As per the protocol agreed to by the FDA, the non-inferiority\nmargin for the lower bound is -4.5 letters of mean BCVA when compared to\naflibercept (2 mg) dosed every eight weeks. In a written Type C response\nreceived in August 2024, and a subsequent written response received in\nDecember 2024, the FDA agreed that the SOL-R repeat dosing wet AMD trial, with\na primary endpoint at Week 56, should be appropriate as an adequate and\nwell-controlled trial in support of a potential New Drug Application and\nproduct label for wet AMD. The trial will remain masked to the Company\nfollowing the primary endpoint Week 56 time point, as key secondary endpoints\nwill be evaluated through Week 96.\n\nAbout the SOL-X Trial\nThe SOL-X trial (NCT07516132) is a multi-center, 36-month open-label extension\ntrial designed to evaluate the long-term safety, efficacy, and disease\nmodifying potential of AXPAXLI in wet AMD for subjects who have successfully\ncompleted their two-year safety follow-up visits in either the SOL-1 or SOL-R\ntrials. The first subject enrolled in the study in April 2026.\n\nAccording to the trial design, all subjects will be given AXPAXLI every 24\nweeks, starting at Day 1 (after completion of the Week 104 visit in SOL-1, or\nWeek 96 visit in SOL-R), and again at Weeks 24, 48, 72, 96, and 120. Subjects\nare assessed at Week 4, Week 12, and then every 12 weeks thereafter.\nAdditional visits can be conducted with supplemental anti-VEGF injection\nadministered based on investigator discretion.\n\nThe primary objectives of SOL-X are to evaluate the long-term safety of\nAXPAXLI; to explore long-term visual outcomes, including visual acuity and the\nincidence and/or progression of fibrosis and macular atrophy; and to evaluate\nthe impact of delayed initiation of AXPAXLI in patients who initially were\nrandomized to receive aflibercept in either SOL-1 or SOL-R.\n\nAbout the HELIOS-3 Trial\nThe registrational Phase 3 HELIOS-3 trial (NCT07235085) is designed to\nevaluate the safety and efficacy of AXPAXLI in a multi-center, double-masked,\nrandomized (1:1) two-arm superiority trial. The trial is designed to enroll\napproximately 620 subjects with moderately severe to severe non-proliferative\ndiabetic retinopathy (NPDR) without center-involved diabetic macular edema\n(CI-DME). The first patient was randomized in the HELIOS-3 trial in November\n2025.\n\nSubjects in the first arm receive a single dose of AXPAXLI at Day 1 and are\nre-dosed at Week 48. Subjects in the second arm receive a sham injection at\nDay 1 and Week 48 aligned with the AXPAXLI treatment arm for adequate masking.\nThroughout the trial, subjects are assessed every 4 weeks from Day 1 through\nWeek 56 and every other month thereafter through Week 96.\n\nThe primary endpoint of HELIOS-3 is the ordinal diabetic retinopathy severity\nscore (DRSS) 2-step change status at Week 56 from baseline (≥2-step\nimprovement, ≥2-step worsening, less than 2-step change in either\ndirection).\n\nAbout Wet AMD\nWet age-related macular degeneration (wet AMD) is a leading cause of severe,\nirreversible vision loss affecting approximately 14.8 million individuals\nglobally and 1.8 million in the United States alone. Wet AMD causes vision\nloss due to abnormal new blood vessel growth and hyperpermeability and\nassociated retinal vascularity in the macula, which is primarily stimulated by\nlocal upregulation of vascular endothelial growth factor (VEGF). Without\nprompt and continuous treatment to control this exudative activity, patients\ndevelop irreversible vision loss. With proper treatment, patients may maintain\nvisual function for a period of time and may temporarily regain lost vision.\nChallenges with current therapies include pulsatile, repeated intraocular\ninjections, treatment-related adverse events and up to 40% patient\ndiscontinuation within one year of initiating treatment with continued disease\nprogression. Taken together, these factors lead to undertreatment and a lack\nof long-term vision improvement for patients.\n\nAbout Diabetic Retinal Disease\nDiabetic retinal disease is an increasingly prevalent global health concern,\ndriven by the rapidly rising number of individuals diagnosed with diabetes\neach year.\n\nDiabetic retinopathy (DR) is the most common category of retinal diseases,\naffecting over an estimated 103 million people worldwide. DR is a progressive\ncondition in which retinal blood vessels are damaged following a cascade of\nevents triggered by chronically elevated levels of blood glucose. As many as\nhalf of all diabetic patients are expected to develop some form of DR in their\nlifetime. DR can progress from the non-proliferative (NPDR) stages to the\nproliferative (PDR) stage characterized by the growth of abnormal new blood\nvessels. Fewer than 1% of the 6.4 million NPDR patients in the U.S. receive\ntreatment today, despite the availability of anti-VEGF therapies approved for\nthe indication, largely due to the burden of frequent injections.\n\nDiabetic macular edema (DME) is also a leading cause of vision loss in the\nworking-age population. DME, the result of an accumulation of fluid in the\nmacula that can afflict patients with diabetes, can occur at any stage of DR.\nIn patients with DME, blood vessels in the eyes leak and start to swell, which\ncan cause vision loss or blindness. Anti-VEGF drugs are approved to treat DME,\nbut these treatments typically require frequent intravitreal injections,\nplacing a significant burden on patients and physicians alike.\n\nAbout Ocular Therapeutix, Inc.\nOcular Therapeutix, Inc. is an integrated biopharmaceutical company committed\nto redefining the retina experience. AXPAXLI™ (also known as OTX-TKI),\nOcular’s investigational product candidate for retinal disease, is an\naxitinib intravitreal hydrogel based on its ELUTYX™ proprietary\nbioresorbable hydrogel-based formulation technology. AXPAXLI is currently in\nPhase 3 clinical trials for wet age-related macular degeneration (wet AMD) and\ndiabetic retinal disease, including non-proliferative diabetic retinopathy\n(NPDR).\n\nOcular’s pipeline also leverages the ELUTYX technology in its commercial\nproduct DEXTENZA(®), an FDA-approved corticosteroid for the treatment of\nocular inflammation and pain following ophthalmic surgery in adults and\npediatric patients and ocular itching associated with allergic conjunctivitis\nin adults and pediatric patients aged two years or older, and in its\ninvestigational product candidate OTX-TIC, which is a travoprost intracameral\nhydrogel that has completed a Phase 2 clinical trial for the treatment of\nopen-angle glaucoma or ocular hypertension. Ocular is currently evaluating\nnext steps for the OTX-TIC program.\n\nFollow the Company on its website, LinkedIn, or X.\n\nDEXTENZA(®) is a registered trademark of Ocular Therapeutix, Inc. The Ocular\nTherapeutix logo, AXPAXLI™, ELUTYX™, and Ocular Therapeutix™ are\ntrademarks of Ocular Therapeutix, Inc.\n\nForward-Looking Statements\nThis press release contains forward-looking statements of the Company\nregarding its future expectations, plans, and prospects; statements regarding\nthe development and regulatory status of the Company’s product candidate\nAXPAXLI (also known as OTX-TKI), including the Company’s intention to submit\na new drug application for AXPAXLI for the treatment of wet AMD based on Week\n52 efficacy and safety data from the Company’s SOL-1 Phase 3 clinical trial,\nWeek 52 data from an interim safety analysis to be conducted in the\nCompany’s SOL-R clinical trial, and confirmatory evidence, and planned\namendments to the clinical trial protocols of the Company’s SOL-R and\nHELIOS-3 clinical trials; statements regarding the timing, design, enrollment,\nrandomization, conduct and retention of subjects in the Company’s ongoing\nand planned clinical trials for AXPAXLI, including the SOL-1, SOL-R and SOL-X\nclinical trials for the treatment of wet AMD and the HELIOS-3 trial for\nnon-proliferative diabetic retinopathy; statements regarding the commercial\npotential of AXPAXLI, including market research findings and potential\npricing; statements regarding the timing of the availability of data from the\nSOL-R trial; statements regarding the potential commercialization of AXPAXLI,\nincluding statements regarding the potential pricing and label of AXPAXLI and\nthe timing of a potential commercial launch of AXPAXLI, if approved;\nstatements regarding the Company’s plans to leverage the Section 505(b)(2)\npathway and its potential to accelerate the review timeline of the Company’s\nplanned NDA submission; statements regarding the Company’s cash runway and\nthe sufficiency of the Company’s cash resources; statements regarding the\npotential utility or adoption, if approved, of any of the Company’s product\ncandidates, including AXPAXLI; and other statements containing the words\n“anticipate”, “believe”, “estimate”, “expect”, “intend”,\n“designed”, “goal”, “may”, “might”, “plan”,\n“position”, “predict”, “project”, “target”, “potential”,\n“will”, “would”, “could”, “should”, “continue”, and\nsimilar expressions, all of which constitute forward-looking statements within\nthe meaning of The Private Securities Litigation Reform Act of 1995. Actual\nresults may differ materially from those indicated by such forward-looking\nstatements as a result of various important factors. Such forward-looking\nstatements involve substantial risks and uncertainties that could cause the\nCompany’s development programs, future results, performance, or achievements\nto differ significantly from those expressed or implied by the forward-looking\nstatements. Such risks and uncertainties include, among others, uncertainties\nregarding the initiation, design, timing, conduct and outcomes of the\nCompany’s ongoing clinical trials, including the Company’s SOL-1 trial,\nSOL-R trial, HELIOS-3 trial, and SOL-X trial; the timing and costs involved in\ncommercializing any product or product candidate that receives regulatory\napproval; the risk that the U.S. Food and Drug Administration, or FDA, will\nnot agree with the Company’s interpretation of the written agreements under\nthe Special Protocol Assessments for AXPAXLI, including for the SOL-1 trial,\nor of the minutes of the Company’s Type C meeting with the FDA; uncertainty\nas to whether the FDA will accept a new drug application for AXPAXLI on the\nbasis of a single pivotal clinical trial, notwithstanding discussions the\nCompany has had with the FDA regarding its planned NDA submission; uncertainty\nas to the minimum clinical data required to demonstrate the safety of a\nproposed product candidate such as AXPAXLI, even if the FDA recognizes that\nonly one pivotal clinical trial may be required to demonstrate efficacy and\naccepts the Company’s NDA submission; the risk that even though the FDA has\nagreed with the overall design of the SOL-1 trial, the FDA may not find that\nthe data generated by the trial and submitted by the Company are sufficient to\ndemonstrate the safety and efficacy of AXPAXLI to the degree necessary to\nsupport marketing approval for wet AMD; the risk that the FDA might not agree\nto the Company’s design, protocol, and statistical analysis plan of any of\nits clinical trials for which the Company has not obtained a Special Protocol\nAssessment, including the SOL-R trial; the risk that the Company and the FDA\nmay not agree on, or maintain agreement with respect to, the registrational\npathway for any of its product candidates, including AXPAXLI; uncertainty as\nto whether the Company will be able to timely satisfy the FDA’s other\nrequirements for regulatory approval of AXPAXLI, including the FDA’s\nChemistry, Manufacturing and Control’s requirements, even if the Company can\nsatisfy the FDA’s clinical requirements to demonstrate safety and efficacy;\nuncertainty as to whether the Company’s NDA will qualify for, or whether the\nFDA will agree to review the NDA, if accepted for filing, under the 505(b)(2)\npathway, notwithstanding discussions the Company has had with the FDA\nregarding its planned regulatory pathway, and whether the 505(b)(2) pathway\nwill provide any time-savings as compared to the traditional 505(b)(1)\npathway; uncertainty as to what restrictions, if any, may be imposed on the\nlabel for AXPAXLI, if approved, pending the receipt of additional clinical\ndata or otherwise; uncertainty as to whether the data from earlier clinical\ntrials will be predictive of the data of later clinical trials, particularly\nlater clinical trials that have a different design or utilize a different\nformulation than the earlier trials, whether preliminary or interim data from\na clinical trial or post-hoc analyses of clinical data will be predictive of\nfinal data from such trial, or whether data from a clinical trial assessing a\nproduct candidate for one indication will be predictive of results in other\nindications; uncertainty as to the Company’s ability to retain regulatory\napproval of any product or product candidate that receives regulatory\napproval; uncertainty as to whether data from the Company’s SOL-X trial will\ndemonstrate additional clinically meaningful, long-term benefits;\nuncertainties regarding the potential commercial advantages and/or position of\nthe Company’s product candidates; uncertainty regarding the implementation\nand impact of most-favored-nation and other reference pricing regimes on the\ncommercial potential of AXPAXLI, especially in markets outside the United\nStates; availability of data from clinical trials and expectations for\nregulatory submissions and approvals; the Company’s scientific approach and\ngeneral development progress; uncertainties inherent in estimating the\nCompany’s cash runway, future expenses and other financial results,\nincluding its ability to fund future operations, including clinical trials;\nthe Company’s existing indebtedness and the ability of the Company’s\ncreditors to accelerate the maturity of such indebtedness upon the occurrence\nof certain events of default; and other factors discussed in the “Risk\nFactors” section contained in the Company’s quarterly and annual reports\non file with the Securities and Exchange Commission. In addition, the\nforward-looking statements included in this press release represent the\nCompany’s views as of the date of this press release. The Company\nanticipates that subsequent events and developments may cause the Company’s\nviews to change. However, while the Company may elect to update these\nforward-looking statements at some point in the future, the Company\nspecifically disclaims any obligation to do so, whether as a result of new\ninformation, future events or otherwise, except as required by law. These\nforward-looking statements should not be relied upon as representing the\nCompany’s views as of any date subsequent to the date of this press release.\n\nInvestors & Media\nOcular Therapeutix, Inc.\nBill Slattery\nVice President, Investor Relations\nbslattery@ocutx.com\n\n\n\n Ocular Therapeutix, Inc. \n Consolidated Balance Sheets \n (in thousands, except share and per share data) \n (Unaudited) \n June 30, December 31, \n 2026 2025 \n Assets \n Current assets: \n Cash and cash equivalents $ 598,641 $ 737,060 \n Accounts receivable, net 30,261 30,650 \n Inventory 3,826 3,564 \n Prepaid expenses and other current assets 11,699 10,855 \n Total current assets 644,427 782,129 \n Property and equipment, net 19,456 19,676 \n Restricted cash 1,614 1,614 \n Operating lease assets 5,820 4,638 \n Total assets $ 671,317 $ 808,057 \n Liabilities and Stockholders’ Equity \n Current liabilities: \n Accounts payable $ 6,996 $ 4,154 \n Accrued expenses and other current liabilities 39,056 43,835 \n Operating lease liabilities 3,122 2,817 \n Total current liabilities 49,174 50,806 \n Other liabilities: \n Operating lease liabilities, net of current portion 3,466 2,815 \n Derivative liability 10,910 13,903 \n Deferred revenue 14,000 14,000 \n Notes payable, net 72,795 71,336 \n Other non-current liabilities 931 887 \n Total liabilities 151,276 153,747 \n Commitments and contingencies \n Stockholders’ equity: \n Preferred stock, $0.0001 par value; 5,000,000 shares authorized and no shares issued or outstanding at June 30, 2026 and December 31, 2025, respectively — — \n Common stock, $0.0001 par value; 400,000,000 and 400,000,000 shares authorized and 219,589,303 and 215,927,600 shares issued and outstanding at June 30, 2026 and December 31, 2025, respectively 22 22 \n Additional paid-in capital 1,844,417 1,811,311 \n Accumulated deficit (1,324,398 ) (1,157,023 ) \n Total stockholders’ equity 520,041 654,310 \n Total liabilities and stockholders’ equity $ 671,317 $ 808,057 \n \n\n\n\n Ocular Therapeutix, Inc. \n Consolidated Statements of Operations and Comprehensive Loss \n (in thousands, except share and per share data) \n (Unaudited) \n Three Months Ended Six Months Ended \n June 30, June 30, \n 2026 2025 2026 2025 \n Revenue: \n Product revenue, net $ 13,475 $ 13,395 $ 24,260 $ 24,028 \n Collaboration revenue — 64 — 128 \n Total revenue, net 13,475 13,459 24,260 24,156 \n Costs and operating expenses: \n Cost of product revenue 2,011 1,944 3,340 3,206 \n Research and development 54,138 51,081 120,351 93,938 \n Selling and marketing 17,276 13,729 33,853 27,877 \n General and administrative 22,159 14,346 42,166 30,694 \n Total costs and operating expenses 95,584 81,100 199,710 155,715 \n Loss from operations (82,109 ) (67,641 ) (175,450 ) (131,559 ) \n Other income (expense): \n Interest income 5,449 3,455 11,500 7,282 \n Interest expense (2,792 ) (3,016 ) (5,569 ) (6,000 ) \n Change in fair value of derivative liabilities 689 (641 ) 2,144 (1,619 ) \n Gain on sale of property and equipment — 29 — 29 \n Total other income (expense), net 3,346 (173 ) 8,075 (308 ) \n Net loss $ (78,763 ) $ (67,814 ) $ (167,375 ) $ (131,867 ) \n Net loss per share, basic $ (0.35 ) $ (0.39 ) $ (0.75 ) $ (0.77 ) \n Weighted average common shares outstanding, basic 224,952,428 172,594,662 224,528,253 171,004,629 \n Net loss per share, diluted $ (0.35 ) $ (0.39 ) $ (0.75 ) $ (0.77 ) \n Weighted average common shares outstanding, diluted 224,952,428 172,594,662 224,528,253 171,004,629 \n \n\n\n\n(https://www.globenewswire.com/NewsRoom/AttachmentNg/20ee0f50-7288-4f81-8546-f2ad2050ddbf)\n\n\n\nGlobeNewswire, Inc. 2026","article_body_html":"","raw_payload":{"data":{"id":"nGNX3XnDBc","title":"Ocular Therapeutix™ Reports Second Quarter 2026 Financial Results and Business Highlights","author":"Globe Newswire","ticker":"OCUL","created":"2026-08-03T11:00:00.880Z","tickers":["OCUL"],"exchange":"NASDAQ","article_body":"Ocular’s AXPAXLI(TM) wet AMD NDA submission on track for Q4 2026 following\npositive Type C Meeting with the U.S. FDA in May 2026\n\nFDA Type C Meeting Minutes Formalize SOL-1 Trial with Confirmatory Evidence as\nSufficient to Support Submission of AXPAXLI NDA in wet AMD\n\nAXPAXLI NDA submission to be based on SOL-1 Week 52 efficacy and safety data,\ninterim SOL-R safety data, and confirmatory evidence\n\nPre-NDA meeting scheduled with FDA in Q3 2026 with the NDA submission to\nfollow the Section 505(b)(2) pathway which could accelerate the review\ntimeline by up to 60 days\n\nNew Post Hoc SOL-1 analysis demonstrates up to an estimated 72% reduction in\ntreatment burden over 60 weeks with AXPAXLI as compared to a projected\non-label aflibercept (2 mg) dosing schedule of every 8 weeks\n\nCommercial readiness accelerating ahead of a potential 2027 launch\n\nCash balance of $598.6 million as of June 30, 2026, with expected runway into\n2028\n\nBEDFORD, Mass., Aug. 03, 2026 (GLOBE NEWSWIRE) -- Ocular Therapeutix, Inc.\n(NASDAQ: OCUL, “Ocular”), an integrated biopharmaceutical company\ncommitted to redefining the retina experience, today reported financial\nresults for the second quarter ended June 30, 2026, and provided recent\nbusiness highlights focused on its NDA submission plan and further clinical\ndevelopment for AXPAXLI (also known as OTX-TKI). The Company will not be\nhosting a second quarter 2026 conference call following its recent investor\nday in June. The Company plans to resume quarterly earnings calls for its\nthird quarter 2026 financial results.\n\n“We continue to execute with discipline, precision, and urgency to redefine\nthe retina experience and make AXPAXLI available to patients as early as\npossible. Our June Investor Day marked a pivotal milestone with the\nannouncement of a clear, FDA-aligned path to submit the AXPAXLI NDA for wet\nAMD in the fourth quarter of 2026,” said Pravin U. Dugel, MD, Executive\nChairman, President and CEO of Ocular Therapeutix. “This approach is\ndesigned to support the fastest risk-mitigated path to NDA submission and\nreview. Consistent with the FDA Type C meeting minutes, the AXPAXLI NDA\nsubmission will be based on SOL-1 efficacy and safety data, interim safety\ndata from SOL-R and supporting confirmatory evidence, including axitinib’s\nestablished profile as a VEGFR inhibitor from more than a decade of clinical\nuse since FDA approval for renal cell carcinoma. By pursuing the 505(b)(2)\nregulatory pathway, we believe the AXPAXLI NDA submission is strongly\npositioned to benefit from a review timeline up to 60 days shorter than the\ntypical new molecular entity.”\n\nPeter K. Kaiser, MD, Chief Development Officer of Ocular Therapeutix added,\n“SOL-1 is the first and only successful superiority trial of a novel agent\nagainst an approved anti-VEGF therapy since the class emerged two decades ago.\nToday, up to 40% of wet AMD patients discontinue therapy within the first year\nalone, largely attributable to the treatment burden and its impact on patients\nand caregivers. In a new post-hoc analysis of SOL-1 data applying the SOL-R\nrescue criteria of >5 ETDRS letter loss and ≥75 µm CSFT increase from\nbaseline, we estimate a treatment burden reduction of up to 72% as compared to\na projected on-label dosing regimen of aflibercept (2 mg) over 60 weeks. The\nrobust potential of AXPAXLI to reduce treatment burden in the real-world may\nimprove adherence and long-term outcomes for our patients.”\n\n Estimated Reduction in Treatment Burden Excluding Loading Doses \n Mean Number of Expected Injections Per Subject* AXPAXLI aflibercept (2 mg) Injection Burden Reduction \n From Week -8 to Week 52 1.95 7.00 72 % \n\n\n\n Estimated Reduction in Treatment Burden Including Loading Doses \n Mean Number of Expected Injections Per Subject* AXPAXLI aflibercept (2 mg) Injection Burden Reduction \n From Week -8 to Week 52 3.95 9.00 56 % \n\n*Methodology outlined below in “Recent Achievements and Upcoming\nMilestones”\n\nRecent Achievements and Upcoming Milestones:\n* New Drug Application (NDA) submission for AXPAXLI in wet AMD planned for Q4\n2026, with FDA alignment confirmed in May 2026 Type C meeting minutes. The NDA\nsubmission will be based on SOL-1 efficacy and safety data, an interim SOL-R\nsafety analysis of patients who have reached Week 52 to be conducted in the\nfourth quarter of 2026, and confirmatory evidence. Together with the existing\nSOL-1 safety database, this interim SOL-R safety analysis will bring the\naggregate safety dataset to more than 300 patients with at least one year of\nAXPAXLI safety data and in-line with FDA requirements. A pre-NDA meeting with\nthe FDA is scheduled for the third quarter of 2026. Ocular intends to submit\nthe NDA under the 505(b)(2) pathway, which could accelerate the review\ntimeline by up to 60 days.\n* Post-hoc Analysis of SOL-1 (Phase 3, wet AMD) demonstrates up to an\nestimated 72% reduction in treatment burden over 60 weeks with AXPAXLI\nrelative to a projected on-label dosing regimen of aflibercept (2 mg) every 8\nweeks. The proportion of SOL-1 patients who would have remained rescue-free\nunder the SOL-R rescue criteria of >5 ETDRS letter loss and ≥75 µm CSFT\nincrease from baseline was 66.5% at Week 52. Applying the observed mean rescue\ntreatment rates in SOL-1 to the estimated 33.5% of subjects requiring rescue\nunder the SOL-R criteria corresponded to an average of 0.95 aflibercept (2 mg)\nrescues per subject for all subjects in the AXPAXLI arm through Week 52 after\na single AXPAXLI injection at baseline. The total estimated mean injection\nburden with AXPAXLI represents a 72% reduction counting from the first\nscreening visit at Week -8 excluding loading doses and a 56% reduction when\nloading doses are included, as compared to a projected on-label dosing regimen\nof aflibercept (2 mg) with no rescues.\n* SOL-R (Phase 3, wet AMD) to be amended to maximize AXPAXLI label potential\nfollowing robust SOL-1 results and confirmation from FDA that SOL-R efficacy\ndata is not required for the AXPAXLI NDA submission. With superiority\ndemonstrated at Weeks 36 and 52 against a single injection of aflibercept (2\nmg) in SOL-1, Ocular now plans to evaluate a new key secondary endpoint of\nsuperiority to aflibercept (8 mg) at Week 96 in SOL-R. Another secondary\nendpoint will evaluate prevention of fibrosis and atrophy relative to\naflibercept (2 mg) at Week 96. To facilitate these evaluations, Ocular will\nextend the efficacy analysis and sponsor-masking in SOL-R until the end of\nstudy at Week 96. These outcomes, if positive, have the potential to establish\nAXPAXLI as a best-in-disease agent in wet AMD. Following these changes,\ntopline SOL-R results are now expected in the first quarter of 2028. The\ntrial's primary endpoint, non-inferiority of AXPAXLI to aflibercept (2 mg) at\nWeek 56, remains unchanged.\n* SOL-X (wet AMD) enrollment continues to accelerate, with the vast majority\nof trial investigators and eligible patients opting to participate in the\nopen-label extension study. Subjects who have completed their two-year\nfollow-up in either the SOL-1 or SOL-R trials are eligible to enroll in the\nthree-year open-label extension study evaluating the long-term safety and\noutcomes of AXPAXLI dosed every 24 weeks. Ocular believes sustained VEGF\nsuppression with AXPAXLI may reduce the incidence of fibrosis and atrophy in\nwet AMD, thereby improving long-term outcomes. The first subject enrolled in\nSOL-X in April 2026.\n* Diabetic retinopathy program streamlined to prioritize HELIOS-3 (Phase 3,\nNPDR) as Ocular's potential single registrational trial. HELIOS-3 will now\nevaluate AXPAXLI dosed every 12 months (Q48W) versus sham with the trial size\nbeing reduced from 930 to 620 patients. The decision to amend the HELIOS-3\ndesign was based on AXPAXLI’s observed durability of up to 12 months in\nSOL-1, HELIOS-1 data, and market research showing physician preference for\nonce-yearly dosing. HELIOS-3 is designed to support a broad label in diabetic\nretinal disease, including patients with diabetic macular edema (DME).\n* Commercial readiness activities, including market and payer research,\nadvancing rapidly ahead of a potential 2027 launch of AXPAXLI, if approved.\nFollowing SOL-1's results, market research found that approximately 80% of\nretina specialists surveyed would likely use a product with AXPAXLI’s\nprofile based on SOL-1 data alone, with more than 90% expected to adopt such a\nproduct within its first year, if approved. Physicians cited disease control,\npredictable dosing interval, and seamless fit within existing workflows as key\ndrivers of anticipated use. Ocular's payer team has also engaged 100% of Tier\n1 Medicare Advantage and commercial payers, who have indicated that a label\ndemonstrating superior durability could command premium pricing.\n                                      \nSecond Quarter Ended June 30, 2026, Financial Results:\n\nTotal cash and cash equivalents were $598.6 million as of June 30, 2026. Based\non current plans and related estimates of anticipated cash inflows from\nDEXTENZA(®), the Company believes that its current cash balance is sufficient\nto support its planned operating expenses, debt service obligations, and\ncapital expenditure requirements into 2028.\n\nThis cash projection factors in the completion of the SOL-1 trial and the\ncontinued execution of the SOL-R, the SOL-X and the HELIOS-3 trials. The\nprojection also includes investment in pre-commercial activities and\npreparations for the potential FDA approval and initial launch of AXPAXLI but\ndoes not currently include the full expenses the Company anticipates it needs\nto support the near-term commercialization of AXPAXLI, if approved.\n\nTotal net revenue was $13.5 million for the second quarter of 2026, flat as\ncompared to the comparable quarter of 2025. Total net revenue includes both\ngross DEXTENZA product revenue, net of discounts, rebates, and returns, which\nincreased $0.1 million or 0.6% over Q2 2025, and collaboration revenue, which\nwas $0.0 million in Q2 2026 versus $0.1 million in Q2 2025.\n\nResearch and development expenses for the second quarter of 2026 were $54.1\nmillion versus $51.1 million for the comparable quarter in 2025, reflecting an\nincrease in overall clinical expenses associated with the ongoing SOL-1,\nSOL-R, SOL-X and HELIOS-3 clinical trials, with additional personnel and\nprofessional services to support these clinical trials and preparations to\nsubmit the planned NDA for AXPAXLI in wet AMD.\n\nSelling and marketing expenses were $17.3 million for the second quarter of\n2026, as compared to $13.7 million for the comparable quarter of 2025,\nreflecting an increase in personnel-related costs, including stock-based\ncompensation expense, related to the expansion of our commercial team and\npre-commercial investments to support a potential AXPAXLI launch.\n\nGeneral and administrative expenses were $22.2 million for the second quarter\nof 2026, as compared to $14.3 million for the comparable quarter of 2025,\nreflecting an increase in personnel-related costs, including stock-based\ncompensation expense, professional fees and facility-related costs.\n\nNet loss for the second quarter of 2026 was $(78.8) million, or a net loss\nof $(0.35) per share on both a basic and diluted basis, compared to a net\nloss of $(67.8) million, or a net loss of $(0.39) per share on a basic and\ndiluted basis, for the comparable quarter of 2025.\n\nOutstanding shares as of July 31, 2026, were approximately 225.0 million.\n\nAbout AXPAXLI\nAXPAXLI™ (also known as OTX-TKI) is an investigational, bioresorbable,\nintravitreal hydrogel incorporating axitinib, a small molecule, multi-target,\ntyrosine kinase inhibitor with anti-angiogenic properties, being evaluated for\nthe treatment of wet AMD and diabetic retinal disease.\n\nAbout the SOL-1 Trial\nThe registrational Phase 3 SOL-1 trial (NCT06223958) is designed to evaluate\nthe safety and efficacy of AXPAXLI in a multi-center, double-masked,\nrandomized (1:1), parallel group trial that involves more than 100 clinical\ntrial sites located in the U.S. and Argentina. In December 2024, the trial\ncompleted randomization of 344 treatment-naïve subjects with a diagnosis of\nwet AMD in the study eye. Two randomized subjects withdrew from the trial\nprior to receiving Day 1 treatment.\n\nThe superiority trial has an eight-week loading segment prior to\nrandomization. During the loading segment, subjects who have 20/80 vision or\nbetter and a central subfield thickness (CSFT) of ≤500 μm receive two doses\nof aflibercept (2 mg) at Week -8 and Week -4. Subjects who achieve best\ncorrected visual acuity (BCVA) of 20/20 at Day 1 (baseline) or gain at least\n10 Early Treatment Diabetic Retinopathy Study (ETDRS) letters at Day 1 along\nwith a CSFT of ≤350 μm were then randomized to receive a single dose of\nAXPAXLI (0.45 mg) or a single dose of aflibercept (2 mg). At Week 52 and at\nWeek 76, all subjects are re-dosed with their respective initial treatment of\nAXPAXLI (0.45 mg) or aflibercept (2 mg). Subjects will be followed for safety\nuntil the end of Week 104.\n\nThroughout the trial, subjects are assessed monthly. Trial subjects and\ndesignated trial personnel will remain masked through the end of Week 104. The\nclinical trial protocol requires that, during the trial, subjects in either\narm meeting the pre-specified rescue criteria, which include a BCVA loss of\n≥15 ETDRS letters from baseline or new vision-threatening macular\nhemorrhage, will receive a supplemental dose of aflibercept (2 mg). The\nprotocol provides that after the first rescue injection, rescue therapy may be\nprovided at investigator discretion per their clinical judgement.\n\nThe primary endpoint of SOL-1 is the proportion of subjects who maintain\nvisual acuity, defined as a loss of <15 ETDRS letters of BCVA from baseline,\nat Week 36. Predefined statistical rules were applied to adjust for treatment\ndiscontinuation or deviation as per the pre-specified statistical analysis\nplan. The trial remained masked following Week 36 and subjects were evaluated\nfor treatment durability at Week 52. The trial is being conducted under a\nSpecial Protocol Assessment (SPA) agreement with the FDA.\n\nIn February 2026, Ocular reported positive SOL-1 Week 52 topline data. The\nsuperiority primary endpoint was met with 74.1% of subjects in the AXPAXLI\n(0.45 mg) arm maintaining vision at Week 36, a 17.5% risk difference\n(p=0.0006), compared to the aflibercept (2 mg) arm. A key secondary endpoint\nwas met with 65.9% of subjects treated with AXPAXLI (0.45 mg) maintaining\nvision at Week 52, a 21.1% risk difference (p<0.0001), compared to the\naflibercept (2 mg) arm.\n\nAbout the SOL-R Trial\nThe registrational Phase 3 SOL-R trial (NCT06495918) is designed to evaluate\nthe safety and efficacy of AXPAXLI in a multi-center, double-masked,\nrandomized (2:2:1), three-arm trial that includes sites located in the U.S.,\nArgentina, India, and Australia in subjects who are treatment-naïve or were\ndiagnosed with wet AMD in the study eye within about four months prior to\nenrollment. Further, to qualify for screening, a subject’s study eye must\nhave had a BCVA ETDRS letter score of ≥34 (~20/200). In December 2025, the\ntrial completed the randomization of 640 subjects.\n\nThis non-inferiority trial reflects a patient enrichment strategy over the six\nmonths prior to randomization that includes three screening doses of any\nanti-VEGF therapy, excluding brolucizumab-dbll, and monitoring to exclude\nthose subjects with early persistent fluid or significant retinal fluid\nfluctuations. Subjects who continue to meet eligibility, defined as a CSFT of\n≤350 μm at Week -12 and Week –8, with ≤35 μm CSFT increase at Week -8\nfrom the lowest CSFT at any prior visit, entered a run-in period and received\ntwo loading doses of aflibercept (2 mg) prior to Day 1. Subjects in the first\narm receive a single dose of AXPAXLI (0.45 mg) at Day 1 and are re-dosed at\nWeeks 24, 48, and 72. Subjects in the second arm receive aflibercept (2 mg) on\nDay 1 and per label every eight weeks thereafter. Subjects in the third arm\nreceive a single dose of aflibercept (8 mg) at Day 1 and are re-dosed at Weeks\n24, 48, and 72, aligned with the AXPAXLI treatment arm for adequate masking.\nSubjects will be followed for safety until the end of Week 96. Throughout the\ntrial, subjects are assessed monthly. Trial subjects and designated trial\npersonnel will remain masked through the end of Week 96. Subjects in any arm\nthat meet pre-specified rescue criteria will receive a supplemental dose of\naflibercept (2 mg). The pre-specified rescue criteria include a >5-letter loss\nin visual acuity plus a ≥75 μm increase in CSFT.\n\nThe primary endpoint of SOL-R is to demonstrate non-inferiority in mean BCVA\nchange from baseline between the AXPAXLI and on-label aflibercept (2 mg) arms\nat Week 56. As per the protocol agreed to by the FDA, the non-inferiority\nmargin for the lower bound is -4.5 letters of mean BCVA when compared to\naflibercept (2 mg) dosed every eight weeks. In a written Type C response\nreceived in August 2024, and a subsequent written response received in\nDecember 2024, the FDA agreed that the SOL-R repeat dosing wet AMD trial, with\na primary endpoint at Week 56, should be appropriate as an adequate and\nwell-controlled trial in support of a potential New Drug Application and\nproduct label for wet AMD. The trial will remain masked to the Company\nfollowing the primary endpoint Week 56 time point, as key secondary endpoints\nwill be evaluated through Week 96.\n\nAbout the SOL-X Trial\nThe SOL-X trial (NCT07516132) is a multi-center, 36-month open-label extension\ntrial designed to evaluate the long-term safety, efficacy, and disease\nmodifying potential of AXPAXLI in wet AMD for subjects who have successfully\ncompleted their two-year safety follow-up visits in either the SOL-1 or SOL-R\ntrials. The first subject enrolled in the study in April 2026.\n\nAccording to the trial design, all subjects will be given AXPAXLI every 24\nweeks, starting at Day 1 (after completion of the Week 104 visit in SOL-1, or\nWeek 96 visit in SOL-R), and again at Weeks 24, 48, 72, 96, and 120. Subjects\nare assessed at Week 4, Week 12, and then every 12 weeks thereafter.\nAdditional visits can be conducted with supplemental anti-VEGF injection\nadministered based on investigator discretion.\n\nThe primary objectives of SOL-X are to evaluate the long-term safety of\nAXPAXLI; to explore long-term visual outcomes, including visual acuity and the\nincidence and/or progression of fibrosis and macular atrophy; and to evaluate\nthe impact of delayed initiation of AXPAXLI in patients who initially were\nrandomized to receive aflibercept in either SOL-1 or SOL-R.\n\nAbout the HELIOS-3 Trial\nThe registrational Phase 3 HELIOS-3 trial (NCT07235085) is designed to\nevaluate the safety and efficacy of AXPAXLI in a multi-center, double-masked,\nrandomized (1:1) two-arm superiority trial. The trial is designed to enroll\napproximately 620 subjects with moderately severe to severe non-proliferative\ndiabetic retinopathy (NPDR) without center-involved diabetic macular edema\n(CI-DME). The first patient was randomized in the HELIOS-3 trial in November\n2025.\n\nSubjects in the first arm receive a single dose of AXPAXLI at Day 1 and are\nre-dosed at Week 48. Subjects in the second arm receive a sham injection at\nDay 1 and Week 48 aligned with the AXPAXLI treatment arm for adequate masking.\nThroughout the trial, subjects are assessed every 4 weeks from Day 1 through\nWeek 56 and every other month thereafter through Week 96.\n\nThe primary endpoint of HELIOS-3 is the ordinal diabetic retinopathy severity\nscore (DRSS) 2-step change status at Week 56 from baseline (≥2-step\nimprovement, ≥2-step worsening, less than 2-step change in either\ndirection).\n\nAbout Wet AMD\nWet age-related macular degeneration (wet AMD) is a leading cause of severe,\nirreversible vision loss affecting approximately 14.8 million individuals\nglobally and 1.8 million in the United States alone. Wet AMD causes vision\nloss due to abnormal new blood vessel growth and hyperpermeability and\nassociated retinal vascularity in the macula, which is primarily stimulated by\nlocal upregulation of vascular endothelial growth factor (VEGF). Without\nprompt and continuous treatment to control this exudative activity, patients\ndevelop irreversible vision loss. With proper treatment, patients may maintain\nvisual function for a period of time and may temporarily regain lost vision.\nChallenges with current therapies include pulsatile, repeated intraocular\ninjections, treatment-related adverse events and up to 40% patient\ndiscontinuation within one year of initiating treatment with continued disease\nprogression. Taken together, these factors lead to undertreatment and a lack\nof long-term vision improvement for patients.\n\nAbout Diabetic Retinal Disease\nDiabetic retinal disease is an increasingly prevalent global health concern,\ndriven by the rapidly rising number of individuals diagnosed with diabetes\neach year.\n\nDiabetic retinopathy (DR) is the most common category of retinal diseases,\naffecting over an estimated 103 million people worldwide. DR is a progressive\ncondition in which retinal blood vessels are damaged following a cascade of\nevents triggered by chronically elevated levels of blood glucose. As many as\nhalf of all diabetic patients are expected to develop some form of DR in their\nlifetime. DR can progress from the non-proliferative (NPDR) stages to the\nproliferative (PDR) stage characterized by the growth of abnormal new blood\nvessels. Fewer than 1% of the 6.4 million NPDR patients in the U.S. receive\ntreatment today, despite the availability of anti-VEGF therapies approved for\nthe indication, largely due to the burden of frequent injections.\n\nDiabetic macular edema (DME) is also a leading cause of vision loss in the\nworking-age population. DME, the result of an accumulation of fluid in the\nmacula that can afflict patients with diabetes, can occur at any stage of DR.\nIn patients with DME, blood vessels in the eyes leak and start to swell, which\ncan cause vision loss or blindness. Anti-VEGF drugs are approved to treat DME,\nbut these treatments typically require frequent intravitreal injections,\nplacing a significant burden on patients and physicians alike.\n\nAbout Ocular Therapeutix, Inc.\nOcular Therapeutix, Inc. is an integrated biopharmaceutical company committed\nto redefining the retina experience. AXPAXLI™ (also known as OTX-TKI),\nOcular’s investigational product candidate for retinal disease, is an\naxitinib intravitreal hydrogel based on its ELUTYX™ proprietary\nbioresorbable hydrogel-based formulation technology. AXPAXLI is currently in\nPhase 3 clinical trials for wet age-related macular degeneration (wet AMD) and\ndiabetic retinal disease, including non-proliferative diabetic retinopathy\n(NPDR).\n\nOcular’s pipeline also leverages the ELUTYX technology in its commercial\nproduct DEXTENZA(®), an FDA-approved corticosteroid for the treatment of\nocular inflammation and pain following ophthalmic surgery in adults and\npediatric patients and ocular itching associated with allergic conjunctivitis\nin adults and pediatric patients aged two years or older, and in its\ninvestigational product candidate OTX-TIC, which is a travoprost intracameral\nhydrogel that has completed a Phase 2 clinical trial for the treatment of\nopen-angle glaucoma or ocular hypertension. Ocular is currently evaluating\nnext steps for the OTX-TIC program.\n\nFollow the Company on its website, LinkedIn, or X.\n\nDEXTENZA(®) is a registered trademark of Ocular Therapeutix, Inc. The Ocular\nTherapeutix logo, AXPAXLI™, ELUTYX™, and Ocular Therapeutix™ are\ntrademarks of Ocular Therapeutix, Inc.\n\nForward-Looking Statements\nThis press release contains forward-looking statements of the Company\nregarding its future expectations, plans, and prospects; statements regarding\nthe development and regulatory status of the Company’s product candidate\nAXPAXLI (also known as OTX-TKI), including the Company’s intention to submit\na new drug application for AXPAXLI for the treatment of wet AMD based on Week\n52 efficacy and safety data from the Company’s SOL-1 Phase 3 clinical trial,\nWeek 52 data from an interim safety analysis to be conducted in the\nCompany’s SOL-R clinical trial, and confirmatory evidence, and planned\namendments to the clinical trial protocols of the Company’s SOL-R and\nHELIOS-3 clinical trials; statements regarding the timing, design, enrollment,\nrandomization, conduct and retention of subjects in the Company’s ongoing\nand planned clinical trials for AXPAXLI, including the SOL-1, SOL-R and SOL-X\nclinical trials for the treatment of wet AMD and the HELIOS-3 trial for\nnon-proliferative diabetic retinopathy; statements regarding the commercial\npotential of AXPAXLI, including market research findings and potential\npricing; statements regarding the timing of the availability of data from the\nSOL-R trial; statements regarding the potential commercialization of AXPAXLI,\nincluding statements regarding the potential pricing and label of AXPAXLI and\nthe timing of a potential commercial launch of AXPAXLI, if approved;\nstatements regarding the Company’s plans to leverage the Section 505(b)(2)\npathway and its potential to accelerate the review timeline of the Company’s\nplanned NDA submission; statements regarding the Company’s cash runway and\nthe sufficiency of the Company’s cash resources; statements regarding the\npotential utility or adoption, if approved, of any of the Company’s product\ncandidates, including AXPAXLI; and other statements containing the words\n“anticipate”, “believe”, “estimate”, “expect”, “intend”,\n“designed”, “goal”, “may”, “might”, “plan”,\n“position”, “predict”, “project”, “target”, “potential”,\n“will”, “would”, “could”, “should”, “continue”, and\nsimilar expressions, all of which constitute forward-looking statements within\nthe meaning of The Private Securities Litigation Reform Act of 1995. Actual\nresults may differ materially from those indicated by such forward-looking\nstatements as a result of various important factors. Such forward-looking\nstatements involve substantial risks and uncertainties that could cause the\nCompany’s development programs, future results, performance, or achievements\nto differ significantly from those expressed or implied by the forward-looking\nstatements. Such risks and uncertainties include, among others, uncertainties\nregarding the initiation, design, timing, conduct and outcomes of the\nCompany’s ongoing clinical trials, including the Company’s SOL-1 trial,\nSOL-R trial, HELIOS-3 trial, and SOL-X trial; the timing and costs involved in\ncommercializing any product or product candidate that receives regulatory\napproval; the risk that the U.S. Food and Drug Administration, or FDA, will\nnot agree with the Company’s interpretation of the written agreements under\nthe Special Protocol Assessments for AXPAXLI, including for the SOL-1 trial,\nor of the minutes of the Company’s Type C meeting with the FDA; uncertainty\nas to whether the FDA will accept a new drug application for AXPAXLI on the\nbasis of a single pivotal clinical trial, notwithstanding discussions the\nCompany has had with the FDA regarding its planned NDA submission; uncertainty\nas to the minimum clinical data required to demonstrate the safety of a\nproposed product candidate such as AXPAXLI, even if the FDA recognizes that\nonly one pivotal clinical trial may be required to demonstrate efficacy and\naccepts the Company’s NDA submission; the risk that even though the FDA has\nagreed with the overall design of the SOL-1 trial, the FDA may not find that\nthe data generated by the trial and submitted by the Company are sufficient to\ndemonstrate the safety and efficacy of AXPAXLI to the degree necessary to\nsupport marketing approval for wet AMD; the risk that the FDA might not agree\nto the Company’s design, protocol, and statistical analysis plan of any of\nits clinical trials for which the Company has not obtained a Special Protocol\nAssessment, including the SOL-R trial; the risk that the Company and the FDA\nmay not agree on, or maintain agreement with respect to, the registrational\npathway for any of its product candidates, including AXPAXLI; uncertainty as\nto whether the Company will be able to timely satisfy the FDA’s other\nrequirements for regulatory approval of AXPAXLI, including the FDA’s\nChemistry, Manufacturing and Control’s requirements, even if the Company can\nsatisfy the FDA’s clinical requirements to demonstrate safety and efficacy;\nuncertainty as to whether the Company’s NDA will qualify for, or whether the\nFDA will agree to review the NDA, if accepted for filing, under the 505(b)(2)\npathway, notwithstanding discussions the Company has had with the FDA\nregarding its planned regulatory pathway, and whether the 505(b)(2) pathway\nwill provide any time-savings as compared to the traditional 505(b)(1)\npathway; uncertainty as to what restrictions, if any, may be imposed on the\nlabel for AXPAXLI, if approved, pending the receipt of additional clinical\ndata or otherwise; uncertainty as to whether the data from earlier clinical\ntrials will be predictive of the data of later clinical trials, particularly\nlater clinical trials that have a different design or utilize a different\nformulation than the earlier trials, whether preliminary or interim data from\na clinical trial or post-hoc analyses of clinical data will be predictive of\nfinal data from such trial, or whether data from a clinical trial assessing a\nproduct candidate for one indication will be predictive of results in other\nindications; uncertainty as to the Company’s ability to retain regulatory\napproval of any product or product candidate that receives regulatory\napproval; uncertainty as to whether data from the Company’s SOL-X trial will\ndemonstrate additional clinically meaningful, long-term benefits;\nuncertainties regarding the potential commercial advantages and/or position of\nthe Company’s product candidates; uncertainty regarding the implementation\nand impact of most-favored-nation and other reference pricing regimes on the\ncommercial potential of AXPAXLI, especially in markets outside the United\nStates; availability of data from clinical trials and expectations for\nregulatory submissions and approvals; the Company’s scientific approach and\ngeneral development progress; uncertainties inherent in estimating the\nCompany’s cash runway, future expenses and other financial results,\nincluding its ability to fund future operations, including clinical trials;\nthe Company’s existing indebtedness and the ability of the Company’s\ncreditors to accelerate the maturity of such indebtedness upon the occurrence\nof certain events of default; and other factors discussed in the “Risk\nFactors” section contained in the Company’s quarterly and annual reports\non file with the Securities and Exchange Commission. In addition, the\nforward-looking statements included in this press release represent the\nCompany’s views as of the date of this press release. The Company\nanticipates that subsequent events and developments may cause the Company’s\nviews to change. However, while the Company may elect to update these\nforward-looking statements at some point in the future, the Company\nspecifically disclaims any obligation to do so, whether as a result of new\ninformation, future events or otherwise, except as required by law. These\nforward-looking statements should not be relied upon as representing the\nCompany’s views as of any date subsequent to the date of this press release.\n\nInvestors & Media\nOcular Therapeutix, Inc.\nBill Slattery\nVice President, Investor Relations\nbslattery@ocutx.com\n\n\n\n Ocular Therapeutix, Inc. \n Consolidated Balance Sheets \n (in thousands, except share and per share data) \n (Unaudited) \n June 30, December 31, \n 2026 2025 \n Assets \n Current assets: \n Cash and cash equivalents $ 598,641 $ 737,060 \n Accounts receivable, net 30,261 30,650 \n Inventory 3,826 3,564 \n Prepaid expenses and other current assets 11,699 10,855 \n Total current assets 644,427 782,129 \n Property and equipment, net 19,456 19,676 \n Restricted cash 1,614 1,614 \n Operating lease assets 5,820 4,638 \n Total assets $ 671,317 $ 808,057 \n Liabilities and Stockholders’ Equity \n Current liabilities: \n Accounts payable $ 6,996 $ 4,154 \n Accrued expenses and other current liabilities 39,056 43,835 \n Operating lease liabilities 3,122 2,817 \n Total current liabilities 49,174 50,806 \n Other liabilities: \n Operating lease liabilities, net of current portion 3,466 2,815 \n Derivative liability 10,910 13,903 \n Deferred revenue 14,000 14,000 \n Notes payable, net 72,795 71,336 \n Other non-current liabilities 931 887 \n Total liabilities 151,276 153,747 \n Commitments and contingencies \n Stockholders’ equity: \n Preferred stock, $0.0001 par value; 5,000,000 shares authorized and no shares issued or outstanding at June 30, 2026 and December 31, 2025, respectively — — \n Common stock, $0.0001 par value; 400,000,000 and 400,000,000 shares authorized and 219,589,303 and 215,927,600 shares issued and outstanding at June 30, 2026 and December 31, 2025, respectively 22 22 \n Additional paid-in capital 1,844,417 1,811,311 \n Accumulated deficit (1,324,398 ) (1,157,023 ) \n Total stockholders’ equity 520,041 654,310 \n Total liabilities and stockholders’ equity $ 671,317 $ 808,057 \n \n\n\n\n Ocular Therapeutix, Inc. \n Consolidated Statements of Operations and Comprehensive Loss \n (in thousands, except share and per share data) \n (Unaudited) \n Three Months Ended Six Months Ended \n June 30, June 30, \n 2026 2025 2026 2025 \n Revenue: \n Product revenue, net $ 13,475 $ 13,395 $ 24,260 $ 24,028 \n Collaboration revenue — 64 — 128 \n Total revenue, net 13,475 13,459 24,260 24,156 \n Costs and operating expenses: \n Cost of product revenue 2,011 1,944 3,340 3,206 \n Research and development 54,138 51,081 120,351 93,938 \n Selling and marketing 17,276 13,729 33,853 27,877 \n General and administrative 22,159 14,346 42,166 30,694 \n Total costs and operating expenses 95,584 81,100 199,710 155,715 \n Loss from operations (82,109 ) (67,641 ) (175,450 ) (131,559 ) \n Other income (expense): \n Interest income 5,449 3,455 11,500 7,282 \n Interest expense (2,792 ) (3,016 ) (5,569 ) (6,000 ) \n Change in fair value of derivative liabilities 689 (641 ) 2,144 (1,619 ) \n Gain on sale of property and equipment — 29 — 29 \n Total other income (expense), net 3,346 (173 ) 8,075 (308 ) \n Net loss $ (78,763 ) $ (67,814 ) $ (167,375 ) $ (131,867 ) \n Net loss per share, basic $ (0.35 ) $ (0.39 ) $ (0.75 ) $ (0.77 ) \n Weighted average common shares outstanding, basic 224,952,428 172,594,662 224,528,253 171,004,629 \n Net loss per share, diluted $ (0.35 ) $ (0.39 ) $ (0.75 ) $ (0.77 ) \n Weighted average common shares outstanding, diluted 224,952,428 172,594,662 224,528,253 171,004,629 \n \n\n\n\n(https://www.globenewswire.com/NewsRoom/AttachmentNg/20ee0f50-7288-4f81-8546-f2ad2050ddbf)\n\n\n\nGlobeNewswire, Inc. 2026"},"type":"article","timestamp":"2026-08-03T11:00:01.183814492Z","server_sent_at_ms":1785754801183},"received_at":"2026-08-03T11:00:01.252Z","source_url":"https://www.globenewswire.com/news-release/2026/08/03/3337365/0/en/ocular-therapeutix-reports-second-quarter-2026-financial-results-and-business-highlights.html"},"analysis":{"id":"95056","press_release_id":"106046","analysis_json":{"industry":{"label":"Biotechnology","sector":"Health Care"},"redFlags":["Net loss widened to $78.8 million in Q2 2026 from $67.8 million in the prior year period"],"eventType":"earnings","narrative":"Ocular Therapeutix reported Q2 revenue of $13.5 million, flat year-over-year, with a net loss of $78.8 million or $0.35 per share.\n\nThe company confirmed its AXPAXLI wet AMD NDA submission remains on track for Q4 2026, utilizing the 505(b)(2) pathway which could accelerate the review timeline by up to 60 days.\n\nA new post-hoc analysis of the SOL-1 trial demonstrated up to a 72% reduction in treatment burden compared to aflibercept, while cash balance stands at $598.6 million providing runway into 2028.","sentiment":"bullish","agentHooks":{"shouldPost":true,"suggestedAngle":"Q4 AXPAXLI NDA path solidified with potential 60-day review shortcut via 505(b)(2) pathway."},"keyFigures":{"revenue":"$13.5 million","revenueYoy":"flat","customDimensions":{"cash_runway":"into 2028","cash_balance":"$598.6 million","shares_outstanding":"225.0 million","nda_submission_timeline":"Q4 2026","treatment_burden_reduction":"72%","review_timeline_acceleration":"up to 60 days"}},"quotedText":"This approach is designed to support the fastest risk-mitigated path to NDA submission and review.","namedEntities":{"people":[{"name":"Pravin U. 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While the financials show widening losses typical for pre-commercial biotechs, the clinical progress and treatment burden data are positive catalysts."},"tickerRelevance":{"others":[],"primary":"OCUL"},"globalImportance":25,"audienceRelevance":20,"eventTypeSecondary":["clinical_trial","operations_update"],"importanceComponents":{"tickerTier":"small-cap","eventGravity":"quarterly-update-with-pipeline-clarity","sectorWeight":"biotech"}},"event_type":"earnings","event_type_secondary":["clinical_trial","operations_update"],"sentiment":"bullish","material_impact_score":3,"narrative":"Ocular Therapeutix reported Q2 revenue of $13.5 million, flat year-over-year, with a net loss of $78.8 million or $0.35 per share.\n\nThe company confirmed its AXPAXLI wet AMD NDA submission remains on track for Q4 2026, utilizing the 505(b)(2) pathway which could accelerate the review timeline by up to 60 days.\n\nA new post-hoc analysis of the SOL-1 trial demonstrated up to a 72% reduction in treatment burden compared to aflibercept, while cash balance stands at $598.6 million providing runway into 2028.","key_figures":{"revenue":"$13.5 million","revenueYoy":"flat","customDimensions":{"cash_runway":"into 2028","cash_balance":"$598.6 million","shares_outstanding":"225.0 million","nda_submission_timeline":"Q4 2026","treatment_burden_reduction":"72%","review_timeline_acceleration":"up to 60 days"}},"named_entities":{"people":[{"name":"Pravin U. 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