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Ocular Therapeutix™ Announces Pricing of Underwritten Offering of Common Stock
Globenewswire· 2025-09-30 11:08
BEDFORD, Mass., Sept. 30, 2025 (GLOBE NEWSWIRE) -- Ocular Therapeutix, Inc. (Nasdaq: OCUL) (“Ocular”, the “Company”), an integrated biopharmaceutical company committed to redefining the retina experience, today announced the pricing of an underwritten offering of 37,909,018 shares of its common stock at an offering price of $12.53 per share for gross proceeds of approximately $475.0 million, before deducting underwriting discounts and commissions and other offering expenses payable by the Company. All of th ...
Ocular Therapeutix™ to Participate in September Investor and Scientific Conferences
Globenewswire· 2025-08-27 11:00
Core Viewpoint - Ocular Therapeutix, Inc. is actively participating in several investor and scientific conferences in September 2025 to showcase its advancements in retinal therapies and engage with the investment community [1][2][3]. Upcoming Investor Conferences - Ocular Therapeutix will present at the Morgan Stanley 23rd Annual Global Healthcare Conference on September 8, 2025, from 2:35 to 3:10 PM ET, with Dr. Pravin U. Dugel as the presenter [2]. - The company will also participate in the Baird 2025 Global Healthcare Conference on September 9, 2025, from 12:50 to 1:20 PM ET, again featuring Dr. Pravin U. Dugel [2]. - Live webcasts of these presentations will be available on the Ocular Therapeutix website, with replays archived for at least 30 days [2]. Upcoming Scientific Conferences - Ocular Therapeutix will present at the EURETINA Innovation Spotlight on September 3, 2025, in Paris, focusing on redefining the retina experience, with Dr. Peter K. Kaiser as the presenter [3]. - The company will also participate in the Ophthalmology Futures Forums Retina Forum on the same day, with Dr. Peter K. Kaiser presenting in two sessions [4][5]. - At the 25th EURETINA Congress from September 4-7, 2025, Ocular will host a symposium titled "Advancing Retinal Disease Treatment: Exploring OTX-TKI's Potential to Extend Treatment Durability" on September 6, 2025 [5]. Company Overview - Ocular Therapeutix is an integrated biopharmaceutical company focused on redefining the retina experience, with its investigational product AXPAXLI™ (OTX-TKI) currently in Phase 3 clinical trials for wet age-related macular degeneration [8]. - The company also leverages its proprietary ELUTYX™ technology in its commercial product DEXTENZA, an FDA-approved corticosteroid for treating ocular inflammation and pain, and in its investigational product OTX-TIC, currently in Phase 2 trials for open-angle glaucoma [9].
Ocular Therapeutix™ Receives FDA Agreement Under Special Protocol Assessment (SPA) for Registrational Trial of AXPAXLI™ in NPDR
Globenewswire· 2025-08-12 11:00
Core Insights - Ocular Therapeutix has received FDA agreement on the registrational trial design for AXPAXLI targeting non-proliferative diabetic retinopathy (NPDR) [1][2] - The company plans to present its clinical trial design and development strategy for NPDR and diabetic macular edema (DME) at an Investor Day on September 30, 2025 [1][2] Company Overview - Ocular Therapeutix is an integrated biopharmaceutical company focused on redefining the retina experience with its investigational product AXPAXLI, a bioresorbable intravitreal hydrogel incorporating axitinib [3][8] - AXPAXLI is currently in Phase 3 clinical trials for wet age-related macular degeneration (wet AMD) and is being evaluated for diabetic retinopathy and DME [8] Market Opportunity - Diabetic retinopathy affects nearly 9 million people in the U.S., with a significant portion of patients not receiving treatment despite the availability of effective therapies [2][6] - The potential for AXPAXLI to provide annual dosing could transform treatment approaches, shifting from reactive to proactive disease management [2][6] Clinical Trial Insights - In the Phase 1 HELIOS trial, AXPAXLI demonstrated no disease progression or vision-threatening complications in NPDR patients at 48 weeks, compared to 25% worsening in the control group [2][6] - The treatment showed improvement in all patients with non-center involved DME, indicating its potential to reshape proactive care in diabetic eye disease [2][6] Public Health Impact - With 6.4 million Americans living with NPDR and fewer than 1% currently treated, AXPAXLI's long-acting treatment could significantly reduce vision-threatening complications from diabetes [2][6][7]
OCUL Sales Drop 18%
The Motley Fool· 2025-08-06 01:12
Core Viewpoint - Ocular Therapeutix reported a significant widening of net loss in Q2 2025 due to increased research and marketing investments, alongside a decline in commercial revenue from its only marketed product, DEXTENZA [1][5][6] Financial Performance - Revenue (GAAP) for Q2 2025 was $13.5 million, slightly above expectations of $13.46 million, but down 18.1% from $16.4 million in Q2 2024 [2][5] - Net loss per share (GAAP) was $(0.39), missing analyst estimates by 8.4% and representing a 50% increase from $(0.26) in Q2 2024 [2][5] - Research and Development (R&D) expenses rose 76.9% to $51.1 million, driven by costs associated with two major Phase 3 trials [2][6] - Selling and Marketing expenses increased 37% to $13.7 million, reflecting pre-commercialization activities for AXPAXLI [2][6] - Cash and cash equivalents stood at $391.1 million as of June 30, 2025, with management indicating this provides a runway into 2028 [2][9] Product and Market Overview - DEXTENZA, the company's FDA-approved ocular implant, faced reimbursement challenges, leading to an 18.1% decline in net revenue despite a 5% increase in unit sales [5][8] - The company is focusing on advancing late-stage clinical trials for AXPAXLI, an ocular implant targeting wet age-related macular degeneration (AMD) [4][7] Clinical Development - The SOL-1 and SOL-R trials for AXPAXLI are progressing on schedule, with topline data from SOL-1 expected in Q1 2026 and primary endpoint data from SOL-R anticipated in the first half of 2027 [7] - Positive feedback was received from the FDA regarding potential designs for future studies in non-proliferative diabetic retinopathy (NPDR) and diabetic macular edema (DME) [7] Strategic Focus and Future Outlook - The company did not provide specific financial guidance for the upcoming quarter but emphasized the importance of advancing AXPAXLI's pivotal trials and maintaining cash reserves [10][11] - Future performance will depend on managing DEXTENZA's reimbursement pressures and executing late-stage clinical programs [11]
Ocular Therapeutix™ Reports Second Quarter 2025 Financial Results and Business Highlights
Globenewswire· 2025-08-05 11:00
Core Insights - Ocular Therapeutix is advancing its clinical trials for AXPAXLI, targeting wet age-related macular degeneration (AMD) with significant milestones expected in 2026 and 2027 [1][2][3] Clinical Trials and Development - SOL-1 trial is on track for topline data in Q1 2026, while SOL-R trial is expected to report topline data in H1 2027 [1][3] - A long-term extension study for both SOL trials is planned to follow patients after completion, aiming to gather additional safety and efficacy data [1][6] - SOL-R has streamlined rescue criteria to align with real-world clinical practices, enhancing its relevance and applicability [3][4] Financial Performance - As of June 30, 2025, the company reported a cash balance of $391.1 million, sufficient to support operations into 2028 [5][6] - Total net revenue for Q2 2025 was $13.5 million, an 18.1% decrease from $16.4 million in Q2 2024, attributed to a challenging reimbursement environment [7][8] - Research and development expenses increased to $51.1 million in Q2 2025, reflecting the costs associated with ongoing clinical trials [9] Strategic Initiatives - The company raised approximately $97 million in gross proceeds through an at-the-market facility in June 2025, enhancing financial flexibility [5][6] - An Investor Day is scheduled for September 30, 2025, to discuss the clinical strategy and commercial outlook for AXPAXLI [5][6] Market Context - Wet AMD affects approximately 14.5 million individuals globally, highlighting a significant market opportunity for innovative treatments like AXPAXLI [22] - Current therapies face challenges such as treatment burden and high patient discontinuation rates, indicating a need for more sustainable treatment options [22]
Ocular Therapeutix™ to Report Second Quarter 2025 Financial Results on August 5, 2025
Globenewswire· 2025-07-29 11:00
Core Viewpoint - Ocular Therapeutix, Inc. is set to discuss its recent business progress and financial results for Q2 2025 in an upcoming conference call on August 5, 2025 [1]. Group 1: Company Overview - Ocular Therapeutix, Inc. is a biopharmaceutical company focused on redefining the retina experience [3]. - The company is developing AXPAXLI™ (OTX-TKI), an investigational product for retinal disease, currently in Phase 3 clinical trials for wet age-related macular degeneration (wet AMD) [3]. - Ocular's pipeline includes DEXTENZA, an FDA-approved corticosteroid for treating ocular inflammation and pain post-surgery, and OTX-TIC, an investigational product in Phase 2 trials for open-angle glaucoma or ocular hypertension [4]. Group 2: Conference Call Details - The conference call and webcast will take place on August 5, 2025, at 8:00 AM ET [2]. - Participants can join via U.S. dial-in at 1-877-407-9039 or international dial-in at 1-201-689-8470 [2]. - The live and archived webcast will be accessible on the Ocular Therapeutix website for at least 30 days [2].
Ocular Therapeutix™ to Participate in Upcoming Scientific Conferences
Globenewswire· 2025-07-22 11:00
Core Insights - Ocular Therapeutix, Inc. is actively participating in several scientific conferences in July and August 2025, showcasing its commitment to advancing retinal therapies [1] Conference Participation - Ocular Therapeutix will present at the 8th Annual OIS Retina Innovation Summit on July 29, 2025, focusing on drug delivery, with Sanjay Nayak as the presenter [2] - At the American Society of Retinal Specialists (ASRS) 2025 Annual Scientific Meeting on July 31, 2025, Ocular will present research on diabetic retinopathy, including a study on Axitinib Hydrogel [3] - The company will also present a poster at the Women in Ophthalmology (WIO) 2025 conference on August 9-10, 2025, discussing macular fluid volume and retinal vascular leakage [4] Product Pipeline - Ocular Therapeutix is developing AXPAXLI™ (OTX-TKI), an investigational axitinib intravitreal hydrogel for retinal diseases, currently in Phase 3 trials for wet age-related macular degeneration [5] - The company’s pipeline includes DEXTENZA, an FDA-approved corticosteroid for ocular inflammation and pain, and OTX-TIC, a travoprost intracameral hydrogel in Phase 2 trials for open-angle glaucoma [6][7]
Ocular Therapeutix™ Unveils New Corporate Branding, Reflecting its Transformation to a Retina-Focused Company
Globenewswire· 2025-06-26 17:54
Core Insights - Ocular Therapeutix has launched a new corporate branding and website, marking a significant transformation towards becoming a retina-focused company [1][8] - The new branding reflects the company's innovative vision and commitment to redefining the retina experience, particularly in the treatment of retinal diseases [3][6] Company Overview - Ocular Therapeutix, Inc. is a biopharmaceutical company dedicated to redefining the retina experience, with a focus on innovative treatments for retinal diseases [9] - The investigational therapy AXPAXLI™ (OTX-TKI) is an axitinib hydrogel designed for intravitreal injection, aimed at improving treatment durability and long-term outcomes for patients with wet age-related macular degeneration (wet AMD) [7][9] Market Context - Wet AMD affects approximately 1.8 million people in the U.S., and current treatment options often require up to 12 injections per year, leading to patient burden and potential treatment discontinuation [6] - The company aims to disrupt existing treatment paradigms for retinal diseases, addressing the high burden associated with current pulsatile treatments [6][3] Product Pipeline - Ocular's pipeline includes AXPAXLI™, currently in Phase 3 clinical trials for wet AMD, and DEXTENZA, an FDA-approved corticosteroid for ocular inflammation and pain [10] - The investigational product OTX-TIC is in Phase 2 clinical trials for open-angle glaucoma or ocular hypertension, leveraging the company's proprietary ELUTYX™ technology [10]
Ocular Therapeutix™ to Participate in Clinical Trials at the Summit (CTS) 2025
Globenewswire· 2025-06-16 11:00
BEDFORD, Mass., June 16, 2025 (GLOBE NEWSWIRE) -- Ocular Therapeutix, Inc. (NASDAQ: OCUL, "Ocular"), a fully-integrated biopharmaceutical company committed to redefining the retina experience, today announced participation at Clinical Trials at the Summit 2025, taking place on June 21, 2025, in Las Vegas, NV. Clinical Trials at the Summit (CTS) 2025 Presentation Details: Session: Tyrosine Kinase Inhibitors in Clinical Trials Presentation Date/Time: Saturday, June 21, 2025, 9:05 – 9:09 AM PT Presenter: Patri ...
Ocular Therapeutix (OCUL) 2025 Conference Transcript
2025-05-20 19:37
Summary of Ocular Therapeutix (OCUL) Conference Call Company Overview - Ocular Therapeutix is focused on developing treatments for ocular diseases, particularly wet age-related macular degeneration (AMD) [2][4] - The company is currently conducting pivotal trials, SOUL-one and SOLAR, aimed at evaluating their lead product, expaxly [2][3] Key Points and Arguments Current Status of Trials - Enrollment for the SOUL-one study is ahead of schedule, with a focus on high-quality patient selection [2][3] - The company is prioritizing the conduct of SOUL-one and SOLAR trials, assessing parameters such as the number and profile of patient rescues [3][4] Market Context - The wet AMD market is valued at approximately $10 billion, with a significant dropout rate of 40% in the first year of treatment [13][15] - The company aims to address the dropout issue, which leads to increased healthcare costs due to blindness [15][16] Treatment Advantages - Ocular Therapeutix is addressing two main problems: sustainability of treatment and long-term visual outcomes [5][7] - The company believes that sustained delivery of their treatment will reduce the risk of fibrosis and improve visual outcomes compared to current anti-VEGF therapies [7][25] Regulatory Environment - Communication with the FDA remains consistent, with no significant changes noted under the new administration [8][9] - The company has received a Special Protocol Assessment (SPA) from the FDA, indicating a clear regulatory pathway for their trials [9][28] Economic Considerations - The company asserts that their treatment could lead to significant cost savings for payers by reducing the dropout rate and associated healthcare costs [15][21] - There is a belief that physicians will benefit economically from the adoption of longer-acting treatments, despite initial concerns about reduced injection frequency [19][22] Trial Design and Modifications - Recent modifications to the SOLAR trial include redosing at twelve months and a reduction in the number of patients for SOLAR, which the company claims will not affect the primary endpoint or powering [26][28] - The company is confident in the quality of patient retention and the design of their trials, which are tailored to meet FDA requirements [33][34] Commercialization Strategy - Ocular Therapeutix plans to commercialize expaxly independently, leveraging their existing commercial team and expertise in the retina market [49][51] - The company is not seeking partnerships at this time, indicating strong financial health and operational capability [50][51] Additional Important Insights - The company emphasizes the tragic nature of the current dropout rates in wet AMD treatment and the urgent need for effective solutions [5][15] - There is a focus on the long-term implications of treatment oscillations and their impact on patient outcomes, which the company believes their product can mitigate [25][26] This summary encapsulates the key points discussed during the conference call, highlighting the company's strategic focus, market context, and ongoing trials.