Ocular Therapeutix (OCUL) came out with a quarterly loss of $0.37 per share versus the Zacks Consensus Estimate of a loss of $0.29. This compares to loss of $0.24 per share a year ago. These figures are adjusted for non-recurring items.This quarterly report represents an earnings surprise of -27.59%. A quarter ago, it was expected that this biotechnology company would post a loss of $0.24 per share when it actually produced a loss of $0.29, delivering a surprise of -20.83%.Over the last four quarters, the c ...

Clinical Trials and Regulatory Outlook - AXPAXLI is currently in two Phase 3 clinical trials for wet AMD, with the SOL-1 trial having randomized 344 subjects as of December 2024[101][102]. - The SOL-1 trial aims to assess the safety and efficacy of AXPAXLI compared to aflibercept, with a primary endpoint of maintaining visual acuity at Week 36[101][106]. - The SOL-R trial, initiated in June 2024, plans to enroll approximately 555 subjects and has a primary endpoint of non-inferiority in mean change in BCVA at Week 56[107][109]. - The FDA agreed that the SOL-R trial should support a potential NDA for AXPAXLI, indicating a favorable regulatory outlook[108]. - The company plans to submit an NDA for AXPAXLI for wet AMD if favorable results are obtained from the SOL-1 and SOL-R trials[109]. - The company is actively planning next steps for AXPAXLI in treating NPDR and DME following positive FDA feedback on trial design[110]. Financial Performance - DEXTENZA's net product revenue for Q1 2025 was $10.6 million, a decrease of $4.1 million or 27.7% compared to Q1 2024, attributed to pricing strategy impacts[113]. - Product revenue decreased to $10.6 million for the three months ended March 31, 2025, down from $14.7 million in the same period of 2024, reflecting a decline of $4.1 million year-over-year[135]. - The company reported a net loss of $64.1 million for the three months ended March 31, 2025, compared to a net loss of $64.8 million in the same period of 2024, an improvement of $0.8 million[134]. - The company incurred net losses of $64.1 million for the three months ended March 31, 2025, and accumulated a deficit of $955.1 million as of the same date[158][159]. - Cash used in operating activities was $44.7 million for the three months ended March 31, 2025, primarily due to operating expenses of $74.6 million[168]. Expenses and Cost Management - Research and development expenses increased significantly to $42.9 million for the three months ended March 31, 2025, compared to $20.7 million in 2024, marking an increase of $22.1 million[139]. - Selling and marketing expenses rose to $14.1 million for the three months ended March 31, 2025, up from $10.2 million in 2024, an increase of $3.9 million[144]. - General and administrative expenses increased to $16.3 million for the three months ended March 31, 2025, compared to $14.1 million in 2024, reflecting a rise of $2.2 million[146]. - The company anticipates that research and development expenses will continue to increase significantly for the remainder of 2025 and beyond as it progresses with ongoing clinical trials[142]. Cash and Financing - As of March 31, 2025, the company had cash and cash equivalents of $349.7 million and outstanding notes payable of $82.5 million under the Barings Credit Facility[154]. - The company plans to fund future capital requirements through equity offerings, debt financings, and collaborations, with no committed external sources of funds currently available[165]. - The company reported a net cash increase of $287.1 million for the three months ended March 31, 2024, primarily from financing activities[171]. - The company has total contractual obligations of $91.0 million, including $82.5 million under the Barings Credit Agreement[173]. - The company has a secured term loan facility with a principal amount of $82.5 million under a credit and security agreement with Barings Finance LLC as of March 31, 2025[187]. Market and Sales Performance - In-Market Sales of DEXTENZA were approximately 40,000 units in Q1 2025, a slight decrease of about 1,000 units from Q1 2024[114]. - The total gross-to-net provisions for DEXTENZA product sales were 49.4% for the three months ended March 31, 2025, compared to 36.1% in 2024[136]. - The company aims to commercialize DEXTENZA in the United States while expanding its operational and management systems[163]. Other Financial Considerations - Interest income was $3.8 million for the three months ended March 31, 2025, down from $3.9 million in 2024, a decrease of $0.1 million[149]. - Interest expense decreased to $3.0 million for the three months ended March 31, 2025, from $4.1 million in 2024, a reduction of $1.1 million[150]. - The Royalty Fee Derivative Liability was valued at $13.9 million as of March 31, 2025[188]. - The company is obligated to pay Incept a royalty equal to a low-single-digit percentage of net sales for Licensed Products in the Ophthalmic Field of Use[178]. - The company is also obligated to pay a mid-single-digit percentage royalty for Licensed Products in the Additional Field of Use[178]. - The company has no off-balance sheet arrangements as defined by the SEC regulations[179]. - An immediate 100 basis point change in interest rates would not have a material effect on the fair market value of the company's investment portfolio[185]. - The company evaluates its estimates and judgments related to revenue recognition and accrued research and development expenses on an ongoing basis[183]. - The company does not enter into financial instruments for trading or speculative purposes[186]. - Changes in the fair value of the Royalty Fee Derivative Liability have no impact on anticipated cash outflows related to this liability[188].

Exhibit 99.1 Ocular Therapeutix™ Reports First Quarter 2025 Results and Business Highlights AXPAXLI™ SOL trials for wet AMD progressing rapidly following recent updates to accelerate and enhance the registrational program Following positive FDA feedback for potential AXPAXLI NPDR registrational trial, Ocular is actively planning next steps in NPDR and DME SOL-1 retention remains exceptional as trial is on track for 1Q 2026 topline data readout SOL-R continues to have strong enrollment through streamlined, a ...

AXPAXLI™ SOL trials for wet AMD progressing rapidly following recent updates to accelerate and enhance the registrational program Following positive FDA feedback for potential AXPAXLI NPDR registrational trial, Ocular is actively planning next steps in NPDR and DME SOL-1 retention remains exceptional as trial is on track for 1Q 2026 topline data readout SOL-R continues to have strong enrollment through streamlined, accelerated execution Cash balance of $349.7M as of March 31, 2025, with expected runway thr ...

BEDFORD, Mass., April 29, 2025 (GLOBE NEWSWIRE) -- Ocular Therapeutix, Inc. (NASDAQ: OCUL, "Ocular"), a biopharmaceutical company committed to redefining the retina experience, today announced participation in several upcoming investor and scientific conferences in the first half of May 2025. Upcoming Investor Conferences Panel Title: Retina in Office Session 5: I Shall be Released: Novel Drug Delivery Approaches for Glaucoma and Retina Session Date/Time: Friday, May 2, 2025, 12:30 – 1:30 PM MT Panelist: Na ...

About Ocular Therapeutix, Inc. Ocular Therapeutix, Inc. is a biopharmaceutical company committed to redefining the retina experience. AXPAXLI™ (axitinib intravitreal hydrogel, also known as OTX-TKI), Ocular's investigational product candidate for retinal disease, is based on its ELUTYX™ proprietary bioresorbable hydrogel-based formulation technology. AXPAXLI is currently in Phase 3 clinical trials for wet age-related macular degeneration (wet AMD). BEDFORD, Mass., April 28, 2025 (GLOBE NEWSWIRE) -- Ocular T ...

Date: Thursday, April 17, 2025 Ocular Therapeutix to host investor one-on-one meetings Location: Boston, MA A live webcast of the Needham presentation can be accessed by visiting the Ocular Therapeutix website on the Events and Presentations section of the Investor Relations page. About Ocular Therapeutix, Inc. BEDFORD, Mass., March 31, 2025 (GLOBE NEWSWIRE) -- Ocular Therapeutix, Inc. (NASDAQ:OCUL, "Ocular")), a biopharmaceutical company committed to redefining the retina experience, today announced that t ...

The market was seeing Ocular Therapeutix (OCUL -6.52%) very positively this week, and that sunny view pushed the company's stock higher.As of Friday morning before market open, the eye care specialist's shares were up by nearly 5% in price week to date, according to data compiled by S&P Global Market Intelligence. A key catalyst for this was an analyst's bullish initiation of coverage on the biotech's stock. In sight of serious price gainsEarly Tuesday morning, Needham's Serge Belanger formally became an Oc ...

Ocular Therapeutix (NASDAQ: OCUL ) is a biotech working on treatments for retinal diseases. Since my June 2024 article on them, the company has focused on its flagship drug candidate called “Axpaxli.” For context, Axpaxli is intended for wet AMD asMy name is Myriam Hernandez Alvarez. I received the Electronics and Telecommunication Engineering degree from the Escuela Politecnica Nacional, Quito, Ecuador, the M.Sc. degree in computer science from Ohio University, Athens, OH, USA, a graduate degree in Busines ...

Financial Data and Key Metrics Changes - The company reported a cash balance of $392 million as of December 31, 2024, indicating a strong financial position to support ongoing operations and clinical trials [30][31][37] - The company does not intend to raise additional capital in 2025, reflecting confidence in its financial strategy and operational execution [31][37] Business Line Data and Key Metrics Changes - AXPAXLI is positioned as a potential standard of care for wet AMD, with a focus on providing a long-lasting treatment option that could reduce the burden of frequent dosing [8][9] - The company has streamlined the SOL-R trial, reducing the target randomization from 825 to 555 subjects while maintaining robust statistical power of 90% [15][35] Market Data and Key Metrics Changes - The company aims to address the significant unmet need in non-proliferative diabetic retinopathy (NPDR) and diabetic macular edema (DME), where less than 1% of NPDR patients currently receive treatment [26][30] - The HELIOS trial demonstrated compelling results for AXPAXLI in both NPDR and DME, with all patients in the AXPAXLI arm showing improvement at week 48 [27][28] Company Strategy and Development Direction - The company is focused on redefining the retina experience and executing a registrational program for AXPAXLI, with an emphasis on clinical data and regulatory submissions [7][9][33] - The dual nature of the SOL-1 and SOL-R trials is designed to generate a comprehensive clinical data set that supports both regulatory approval and commercial adoption [21][25] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the success of the trials, highlighting the efficiency of the trial designs and the potential for a superior product label [45][46][110] - The company anticipates receiving FDA feedback on clinical trial designs for NPDR and DME in the first half of the year, which will guide future steps in these indications [30][116] Other Important Information - The FDA approved an amendment to the SOL-1 special protocol agreement to incorporate redosing at weeks 52 and 76, enhancing potential label flexibility [10][34] - The company expects to report topline data for SOL-1 in the first quarter of 2026, slightly shifting the timeline but providing long-term benefits [12][34] Q&A Session Summary Question: Can you provide more color on the changes to SOL-1 and the rationale for reducing the size of SOL-R? - Management explained that the changes were made to enhance efficiency and maximize patient exposure to the drug, allowing for a better label and faster market access [41][45][49] Question: What is the rationale for dosing at week 76 in SOL-1? - The rationale is to maximize drug exposure to satisfy FDA safety requirements, with all patients receiving redosing at weeks 52 and 76 [58][60] Question: How do the changes impact the timeline for NDA submission? - The changes are expected to accelerate the timeline for filing, with a focus on achieving a superior label that provides flexibility in dosing [66][110] Question: What are the expectations for durability in SOL-1? - Management indicated that they expect a significant percentage of patients to show durability to 52 weeks without rescue, based on previous study data [120] Question: How quickly will the company advance NPDR and DME trials after receiving FDA feedback? - The timeline for advancing these trials will depend on the FDA meeting, but the company is prepared to implement the trials efficiently [116]