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]

Group 1 - Ocular Therapeutix reported a quarterly loss of $0.29 per share, which was worse than the Zacks Consensus Estimate of a loss of $0.24, representing an earnings surprise of -20.83% [1] - The company posted revenues of $17.08 million for the quarter ended December 2024, exceeding the Zacks Consensus Estimate by 2.40%, and showing an increase from $14.8 million in the same quarter last year [2] - Ocular Therapeutix shares have declined approximately 16.4% since the beginning of the year, contrasting with the S&P 500's gain of 1.2% [3] Group 2 - The earnings outlook for Ocular Therapeutix is mixed, with the current consensus EPS estimate for the upcoming quarter at -$0.27 on revenues of $16.79 million, and -$1.05 on revenues of $70.1 million for the current fiscal year [7] - The Zacks Industry Rank indicates that the Medical - Drugs sector is currently in the bottom 48% of over 250 Zacks industries, suggesting potential underperformance compared to the top 50% of ranked industries [8]

Clinical Trials and Product Development - AXPAXLI is currently in two Phase 3 clinical trials for wet AMD, with over 300 subjects randomized in the SOL-1 trial and 311 subjects enrolled in the SOL-R trial as of January 10, 2025[680][683]. - The SOL-1 trial's topline results are now expected in Q1 2026, with a potential for a 6-12 month dosing label for AXPAXLI[684]. - The company plans to meet with the FDA in the first half of 2025 to discuss a potential registrational clinical program for AXPAXLI targeting NPDR and DME[686]. - The company anticipates significant increases in direct research and development expenses for 2025 as it progresses with ongoing clinical trials[719]. - The company expects to continue incurring losses as it advances clinical trials for product candidates, including AXPAXLI, and increases sales and marketing resources for DEXTENZA[739]. - The company anticipates substantial expenses related to ongoing clinical trials, scaling up manufacturing processes, and expanding sales and marketing capabilities[740]. Financial Performance - Net product revenue for DEXTENZA was $63.5 million for the year ended December 31, 2024, reflecting a 9.7% increase from $57.9 million in 2023[687]. - Total revenue for 2024 was $63.7 million, reflecting a year-over-year increase of $5.3 million (9.0%) from $58.4 million in 2023[711]. - Product revenue, net for the year ended December 31, 2024 was $63.5 million, an increase of $5.6 million (9.7%) from $57.9 million in 2023, all attributable to DEXTENZA sales[711]. - Collaboration revenue decreased to $0.3 million in 2024 from $0.6 million in 2023, reflecting a decline in performance obligations under the license agreement with AffaMed[714]. - The company incurred net losses of $193.5 million, $80.7 million, and $71.0 million for the years ended December 31, 2024, 2023, and 2022, respectively[738]. Expenses and Cost Management - Research and development expenses increased significantly to $127.6 million in 2024, up $66.6 million (109.1%) from $61.1 million in 2023[716]. - Selling and marketing expenses rose to $41.6 million in 2024, an increase of $1.0 million (2.6%) compared to $40.5 million in 2023[720]. - General and administrative expenses increased to $60.7 million in 2024, reflecting a rise of $26.7 million (78.6%) from $33.9 million in 2023[722]. - Interest expense increased to $13.6 million in 2024, up $2.2 million (19.5%) from $11.3 million in 2023, driven by higher debt balances[727]. Cash Flow and Financing Activities - The company raised approximately $316.4 million in a private placement by selling 32,413,560 shares at $7.52 per share in February 2024[692]. - Net cash provided by financing activities was $332.1 million for the year ended December 31, 2024, compared to $169.8 million for 2023[750]. - Net cash provided by financing activities for the year ended December 31, 2024, was $332.1 million, an increase from $169.8 million in 2023, representing a growth of 95.5%[756][757]. - The financing activities in 2024 included proceeds from the issuance of common stock and pre-funded warrants of approximately $316.4 million, and proceeds from the exercise of stock options of $14.7 million[756]. - As of December 31, 2024, the company had cash and cash equivalents of $392.1 million and outstanding notes payable of $82.5 million under the Barings Credit Facility[732]. Market Position and Growth Potential - DEXTENZA is currently used in less than 5% of cataract procedures, indicating significant growth potential in sales to ASCs[689]. - The Medicare Statute allows for continued separate payment of DEXTENZA in the ASC setting for 2025, which may enhance its market position[688]. - The gross-to-net provisions for DEXTENZA product sales were 38.5% in 2024, up from 30.1% in 2023, indicating a shift in pricing strategy[712]. Debt and Obligations - The company has a total borrowing capacity of $82.5 million under the Barings Credit Facility, which has been fully drawn down[749]. - Total contractual obligations and commitments as of December 31, 2024, amounted to $91.2 million, with $2.7 million due within one year and $83.2 million due in 3 to 5 years[760]. - Operating lease commitments total $8.7 million, with $2.7 million due within one year and $5.3 million due in 1 to 3 years[759]. Financial Instruments and Risk Management - The company does not enter into financial instruments for trading or speculative purposes[787]. - An immediate 100 basis point change in U.S. interest rates would not materially affect the fair market value of the company's investment portfolio due to its short-term duration and low risk profile[786]. - A 10% increase or decrease in the interest rate used in the valuation model of the Royalty Fee Derivative Liability would not have a material effect on its fair value[790]. - Expected cash outflows from the secured term loan facility fluctuate based on changes in the Secured Overnight Financing Rate (SOFR)[788]. - An immediate 100 basis point increase or decrease in SOFR would not have a material effect on anticipated cash outflows from the secured term loan facility[789].

Exhibit 99.1 Ocular Therapeutix™ Reports Fourth Quarter and Full Year 2024 Results and Business Highlights Announces several updates to enhance and accelerate AXPAXLI registrational program in wet AMD, potentially supporting label flexibility of 6-12 months to showcase expected best-in-class durability Additional updates provided on SOL-R non-inferiority margin and rescue criteria Cash balance of $392.1M as of December 31, 2024, expected to fund operations into 2028 and the Company currently does not intend ...

Announces several updates to enhance and accelerate AXPAXLI registrational program in wet AMD, potentially supporting label flexibility of 6-12 months to showcase expected best-in-class durability FDA approves Amendment to SOL-1 Special Protocol Agreement (SPA) to include AXPAXLI re-dosing at Weeks 52 and 76 SOL-1 trial Week 36 primary endpoint data now expected in 1Q 2026 due to requirement for masking until Week 52 to allow for re-dosing Inclusion of re-dosing in SOL-1, along with exceptional retention se ...

BEDFORD, Mass., Feb. 25, 2025 (GLOBE NEWSWIRE) -- Ocular Therapeutix, Inc. (NASDAQ: OCUL, “Ocular”), a biopharmaceutical company committed to redefining the retina experience, today announced that the Company will participate in two investor conferences in March: TD Cowen 45th Annual Health Care Conference Presentation DetailsFireside Chat Date: Tuesday, March 4, 2025Fireside Chat Time: 11:50 AM ETPresenter: Pravin U. Dugel, MD, Executive Chairman, President and CEOLocation: Boston, MA Leerink Partners Glob ...

BEDFORD, Mass., Feb. 24, 2025 (GLOBE NEWSWIRE) -- Ocular Therapeutix, Inc. (NASDAQ: OCUL, “Ocular”), a biopharmaceutical company committed to redefining the retina experience, today announced that it plans to host a conference call and webcast on Monday, March 3, 2025, at 8:00 AM ET to discuss recent business progress and financial results for the fourth quarter and full year ended December 31, 2024. Conference Call and Webcast Information: Date: Monday, March 3, 2025, at 8:00 AM ET Participant Dial-In (U.S ...