I have been covering Ocular Therapeutix (NASDAQ: OCUL ) for a while now, and I have not been bullish. However, the stock has not done poorly, and their programs have progressed well. Since my last coverage inAbout the TPT serviceThanks for reading. At the Total Pharma Tracker, we offer the following:-Our Android app and website features a set of tools for DIY investors, including a work-in-progress software where you can enter any ticker and get extensive curated research material. For investors requiring h ...

BEDFORD, Mass. , Nov. 26, 2024 (GLOBE NEWSWIRE) -- Ocular Therapeutix, Inc. (NASDAQ: OCUL, “Ocular”, the “Company”), a biopharmaceutical company committed to improving vision in the real world through the development and commercialization of innovative therapies for retinal diseases and other eye conditions, today announced participation in several investor and scientific conferences being held in December. Piper Sandler 36th Annual Healthcare ConferenceFireside Chat Date: Tuesday, December 3rd, 2024 Firesi ...

Financial Data and Key Metrics Changes - The company reported cash and cash equivalents of approximately $427 million at the end of Q3 2024, providing a runway into 2028 and fully funding the SOL-1 and SOL-R trials to top-line results [27]. Business Line Data and Key Metrics Changes - The company is focused on the clinical development of AXPAXLI for wet age-related macular degeneration (AMD), with significant progress in enrollment for the SOL-1 and SOL-R trials [5][10]. - SOL-1 has reached a key enrollment milestone, and the company expects to complete randomization by year-end 2024, with top-line data anticipated in Q4 2025 [29]. Market Data and Key Metrics Changes - The market for wet AMD is large and underserved, with approximately 1.65 million people affected in the U.S., and up to 40% of patients discontinuing treatment within the first year [5]. Company Strategy and Development Direction - The company aims to become a leader in the treatment of retinal diseases, with a clear mission to improve vision in the real world [28]. - AXPAXLI is positioned to potentially offer a differentiated product label, focusing on treatment durability and repeatability, which may provide both regulatory and commercial advantages [38]. Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the potential success of AXPAXLI based on historical clinical data and the strong demand for participation in clinical studies, indicating a positive outlook for commercial interest [20][24]. - The company is preparing for a significant year in 2025, anticipating impactful milestones with clinical data expected [30]. Other Important Information - The company has taken steps to build its commercial infrastructure to support the manufacture and distribution of AXPAXLI to retina specialists, with plans to expand these efforts in 2025 [26]. Q&A Session Summary Question: How many of the sites for SOL-1 and SOL-R are currently overlapping? - Management confirmed that there are overlapping sites by design, allowing for a seamless transition between SOL-1 and SOL-R, and additional sites are being activated for SOL-R [33]. Question: Can you define what a differentiated product label for AXPAXLI would look like? - Management indicated that the label may include flexibility in treatment frequency and superiority over existing treatments, addressing key clinical questions [36][38]. Question: Will you provide regular updates on SOL-R enrollment progress? - Management stated that updates will be provided as appropriate, emphasizing the seamless transition from SOL-1 to SOL-R and the encouraging recruitment pace for SOL-R [40]. Question: What is the progress of discussions with EMA? - Management confirmed ongoing discussions with regulatory agencies outside the U.S. but did not provide specific details at this time [44]. Question: Can you elaborate on the commercial efforts for AXPAXLI? - Management expressed confidence in achieving premium pricing for AXPAXLI and highlighted the strength of the commercial team that has been successful with DEXTENZA [49]. Question: What are the expectations for the next trial in diabetic retinopathy? - Management indicated a commitment to pursuing diabetic retinopathy and diabetic macular edema, with a focus on preventing vision-threatening complications [56][59]. Question: Will data from SOL-1 and SOL-R need to be submitted simultaneously for regulatory approval? - Management clarified that both studies are required for approval, and they are in close collaboration with the FDA regarding the regulatory path [62].

Ocular Therapeutix (OCUL) came out with a quarterly loss of $0.26 per share versus the Zacks Consensus Estimate of a loss of $0.23. This compares to loss of $0.51 per share a year ago. These figures are adjusted for non-recurring items.This quarterly report represents an earnings surprise of -13.04%. A quarter ago, it was expected that this biotechnology company would post a loss of $0.22 per share when it actually produced a loss of $0.24, delivering a surprise of -9.09%.Over the last four quarters, the co ...

BEDFORD, Mass., Nov. 13, 2024 (GLOBE NEWSWIRE) -- Ocular Therapeutix, Inc. (NASDAQ: OCUL, “Ocular”, the “Company”), a biopharmaceutical company committed to improving vision in the real world through the development and commercialization of innovative therapies for retinal diseases and other eye conditions, today announced upcoming presentations at the Jefferies London Healthcare Conference and Ophthalmology Innovation Summit XIV. Jefferies London Healthcare Conference 2024Fireside Chat Date: Wednesday, Nov ...

BEDFORD, Mass., Nov. 06, 2024 (GLOBE NEWSWIRE) -- Ocular Therapeutix, Inc. (NASDAQ:OCUL) (“Ocular”), a biopharmaceutical company committed to improving vision in the real world through the development and commercialization of innovative therapies for retinal diseases and other eye conditions, today announced that it plans to host a conference call and webcast on Thursday, November 14, 2024, at 8:00 AM ET to discuss recent business progress and financial results for the third quarter ended September 30, 2024 ...

BEDFORD, Mass., Oct. 09, 2024 (GLOBE NEWSWIRE) -- Ocular Therapeutix, Inc. (NASDAQ: OCUL, "Ocular"), a biopharmaceutical company committed to improving vision in the real world through the development and commercialization of innovative therapies for retinal diseases and other eye conditions, today announced participation in multiple panels and presentations across three ophthalmology meetings in Chicago, Illinois during October 2024. Presentation & Panel Details (all times CT): Eyecelerator® @ AAO 2024: Oc ...

BEDFORD, Mass., Sept. 04, 2024 (GLOBE NEWSWIRE) -- Ocular Therapeutix, Inc. (NASDAQ: OCUL, "Ocular", the "Company"), a biopharmaceutical company committed to improving vision in the real world through the development and commercialization of innovative therapies for retinal diseases and other eye conditions, today announced that it will participate in two investor conferences in September: Baird 2024 Global Healthcare Conference Fireside Chat Date: Tuesday, September 10, 2024 Presentation Time: 12:50 PM ET ...

Financial Data and Key Metrics Changes - The company reported approximately $460 million in cash at the end of Q2 2024, providing a cash runway into 2028, which supports ongoing clinical studies [6][12] - The enrollment rate for the SOL-1 study has accelerated and exceeded expectations, indicating strong operational execution [7][14] Business Line Data and Key Metrics Changes - The SOL-1 study is the first of two registration studies for AXPAXLI, focusing on wet AMD, with over 150 patients in various stages of loading and randomization [7][46] - The SOL-R study, which is a repeat dosing study for wet AMD, has been initiated and is designed to complement the SOL-1 study [8][9] Market Data and Key Metrics Changes - The company aims to address the large market size and unmet needs in the treatment of wet AMD, emphasizing the importance of AXPAXLI as a sustainable treatment option [4][5] Company Strategy and Development Direction - The company is transforming into a retina-focused organization, prioritizing the development of AXPAXLI for wet AMD [4][11] - A commitment to financial discipline has led to a reduction in headcount in non-aligned areas, ensuring resources are focused on value-creating activities [6] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the alignment with FDA requirements, which validates the design of the SOL-1 and SOL-R studies [14][22] - The positive initial data from the HELIOS study in non-proliferative diabetic retinopathy (NPDR) is expected to enhance confidence in the success of the ongoing studies [10][33] Other Important Information - The company has achieved significant milestones in a short time, including the activation of 60 sites for the SOL-1 study and the initiation of the SOL-R study within three months [7][8] - The HELIOS study results showed that no patients developed vision-threatening complications after 48 weeks, highlighting the potential of AXPAXLI [10][33] Q&A Session Summary Question: Update on SOL-1 study recruitment timeline - Management indicated that while the previous guidance was for completion in the first half of 2025, the pace of enrollment may allow for earlier completion [18][19] Question: Discussion with EMA regarding SOL studies - Management confirmed ongoing positive discussions with the EMA but did not provide specific updates [18] Question: Clarification on FDA feedback and remaining risks - Management reassured that the FDA's written response aligns with their expectations and mitigates risks regarding study requirements [21][22] Question: Plans for a Special Protocol Assessment (SPA) for SOL-R - Management stated that it is too early to determine if an SPA will be pursued for SOL-R, emphasizing the goal of expediting patient access [24][25] Question: Performance expectations of comparator arms in SOL-R - Management expressed confidence in the selected comparator arms based on historical data and the design of the study [28][30] Question: Enrollment estimates for SOL-R and loading doses - Management clarified that SOL-R will initially recruit patients who screen fail in SOL-1, ensuring it does not cannibalize SOL-1 recruitment [40][42]

SOL-R evaluates repeat AXPAXLI™ dosing for wet age-related macular degeneration (wet AMD) SOL-R is a global, 825-patient, non-inferiority study evaluating repeat dosing of AXPAXLI every six months (Q6M) compared to 2 mg aflibercept, dosed every eight weeks (Q8W) in patients with wet AMD. A third arm evaluating 8 mg aflibercept dosed Q6M is incorporated to ensure the study is adequately masked. The trial is evaluating AXPAXLI versus the current standard of care under the "real world" requirements of a repeat ...