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Kiora Pharmaceuticals Reports Third Quarter 2025 Results; Company Advances Pipeline with Two Actively Enrolling Phase 2 Clinical Trials for Retinal Diseases
Newsfile· 2025-11-07 11:00
Core Insights - Kiora Pharmaceuticals reported its third quarter 2025 financial results and provided updates on its clinical pipeline for retinal diseases, highlighting the advancement of two actively enrolling Phase 2 clinical trials [1][2]. Clinical Trials Update - The company is actively recruiting participants for two Phase 2 clinical trials: ABACUS-2 for KIO-301 aimed at vision restoration in retinitis pigmentosa, and KLARITY for KIO-104 targeting retinal inflammation [2][5]. - The ABACUS-2 trial has expanded its screening and enrollment to include patients from a functional endpoint validation study, potentially increasing the patient population for KIO-301 [2][3]. - KLARITY is designed as a two-stage, multi-dose study focusing on patients with inflammatory retinal diseases causing macular edema, with a pre-defined safety assessment [3]. Financial Highlights - Kiora received $1.2 million in reimbursed R&D expenses from Théa for KIO-301 activities in Q2 2025 and billed $1.5 million in Q3 2025, with $0.3 million received in the same quarter [5][6]. - The company ended Q3 2025 with $19.4 million in cash, cash equivalents, and short-term investments, alongside $1.2 million in collaboration receivables and $1.5 million in tax and research credit receivables [5][6]. - Kiora's cash runway is projected to extend into late 2027, beyond anticipated data readouts for both clinical trials, with potential for further extension through partnership milestones [6]. R&D and Operating Expenses - R&D expenses for Q3 2025 were $2.7 million, an increase from $2.1 million in Q3 2024, primarily due to clinical trial activities [7]. - General and administrative expenses remained stable at $1.4 million for both Q3 2025 and Q3 2024 [7]. Income Statement Overview - Kiora reported a net income of $27 thousand for Q3 2025, a significant improvement from a net loss of $3.4 million in Q3 2024, attributed to favorable tax impacts and control of operating costs [8][14]. - The company recorded total revenue of $16 million for the nine months ended September 30, 2024, primarily from collaboration revenue [14]. Company Profile - Kiora Pharmaceuticals is a clinical-stage biotechnology company focused on developing therapies for retinal diseases using innovative small molecules [9]. - KIO-301 is being developed for retinitis pigmentosa, with plans to expand into other retinal diseases, while KIO-104 targets retinal inflammation [9].
Belite Bio (NasdaqCM:BLTE) 2025 Earnings Call Presentation
2025-11-04 15:30
Early Intervention with an Oral Treatment for Macular Degeneration Mission for Vision Nasdaq: BLTE B E L I T E B I O / 1 Forward-Looking Statements and Legal Disclaimer Market data and industry information used throughout this presentation are based on the knowledge of the industry and the good faith estimates of Belite Bio's management. The Company also relied, to the extent available, upon management's review of independent industry surveys and publications and other publicly available information prepare ...
Eyes On Kiora - ABACUS-2 And KLARITY Data Readouts Due In 2027
RTTNews· 2025-11-04 10:47
Core Insights - Kiora Pharmaceuticals (KPRX) is a clinical-stage biopharmaceutical company focused on developing advanced treatments for retinal diseases [2] Drug Candidates - Kiora has two drug candidates: KIO-301 for inherited retinal diseases and KIO-104 for retinal inflammation [2][7] - KIO-301 targets surviving retinal ganglion cells to restore visual function in patients with retinitis pigmentosa [3] - KIO-104 suppresses T-cells and cytokines to reduce inflammation in the eye [7] Clinical Trials - KIO-301 is undergoing a Phase 2 clinical trial (ABACUS-2) to assess safety, tolerability, and efficacy in patients with late-stage retinitis pigmentosa, enrolling 36 patients [3][4] - KIO-104 is in a Phase 2 clinical trial (KLARITY) for retinal macular edema, with plans to enroll up to 28 patients [8][9] - Results from both clinical trials are expected in early 2027 [10] Financial Position - Kiora ended Q2 2025 with $20.7 million in cash and equivalents, plus $3.1 million in receivables and tax credits, providing a cash runway through late 2027 [11] Company Background - Kiora Pharmaceuticals was formerly known as EyeGate Pharmaceuticals Inc. and rebranded on November 8, 2021 [12] - The company's stock has traded between $2.21 and $4.18 over the past year, closing at $2.47, up 6.93% [12]
Kalaris Expands Leadership Team Appointing Matthew Gall, MBA, as Chief Financial Officer
Globenewswire· 2025-11-03 12:30
Core Insights - Kalaris Therapeutics has appointed Matthew Gall as Chief Financial Officer to enhance its leadership team and support the company's growth as it advances its clinical studies [1][2] - The company is focused on developing treatments for retinal diseases, particularly neovascular age-related macular degeneration (nAMD), diabetic macular edema (DME), and retinal vein occlusion (RVO) [3] Company Overview - Kalaris Therapeutics is a clinical-stage biopharmaceutical company dedicated to addressing major unmet medical needs in retinal diseases [3] - The company was founded by Dr. Napoleone Ferrara, known for his pioneering research in anti-VEGF therapy [3] Leadership and Experience - Matthew Gall brings extensive experience from previous roles at iTeos Therapeutics, Sarepta Therapeutics, Celgene Corporation, and Gilead Sciences, focusing on financial operations and business development [2] - His appointment is expected to bolster Kalaris' strategic direction and support its clinical development efforts [2]
Kodiak Sciences Announces Recent Business Highlights and Second Quarter 2025 Financial Results
Prnewswire· 2025-08-13 20:00
Core Insights - Kodiak Sciences Inc. reported significant advancements in its late-stage clinical assets, particularly focusing on the transformative potential of tarcocimab, KSI-501, and KSI-101 in treating retinal diseases [2][3]. Recent Business Highlights and Upcoming Catalysts - The company held an Investor R&D Day on July 16, 2025, showcasing new data and a commercial vision for its clinical assets [2]. - KSI-101 demonstrated rapid anatomical gains and visual acuity improvements in patients with macular edema secondary to inflammation (MESI) during the Phase 1b APEX study [5]. - Upcoming topline data for tarcocimab and KSI-501 is expected in 1Q 2026 and 3Q 2026, respectively, with KSI-101 data anticipated in 4Q 2026 to 1Q 2027 [5]. Financial Results - Kodiak ended Q2 2025 with $104.2 million in cash and cash equivalents, sufficient to support operations into 2026 [4]. - The net loss for Q2 2025 was $54.3 million, or $1.03 per share, compared to a net loss of $45.1 million, or $0.86 per share, in Q2 2024 [6]. - Research and development expenses rose to $42.8 million in Q2 2025 from $32.5 million in Q2 2024, driven by increased clinical activities [7]. Pipeline Programs - Tarcocimab is an investigational anti-VEGF therapy designed for extended durability in ocular tissues, with ongoing Phase 3 studies in diabetic retinopathy and wet AMD [9][10]. - KSI-501 is a bispecific therapy targeting IL-6 and VEGF, currently in the Phase 3 DAYBREAK study for wet AMD [17][19]. - KSI-101 is being developed for MESI, with ongoing Phase 3 studies (PEAK and PINNACLE) actively enrolling patients [22][26]. Digital Health Initiatives - The VETi program has made significant advancements in AI and machine learning, aimed at enhancing the company's commercial retina franchise [5]. Company Overview - Kodiak Sciences is focused on developing transformative therapeutics for retinal diseases, utilizing its proprietary ABC Platform to create next-generation retinal medicines [29].
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]
Kodiak Sciences Announces Recent Business Highlights and First Quarter 2025 Financial Results
Prnewswire· 2025-05-14 20:15
Core Insights - Kodiak Sciences Inc. reported a net loss of $57.5 million for Q1 2025, compared to a net loss of $43.0 million in Q1 2024, reflecting an increase in operational expenses and R&D investments [4][28]. - The company ended Q1 2025 with $138.9 million in cash and cash equivalents, which is expected to support operations into 2026 [3][29]. - Kodiak is focused on advancing its pipeline, particularly three Phase 3 assets, with topline data anticipated in 2026 [2][3]. Financial Results - The net loss for Q1 2025 was $57.5 million, or $1.09 per share, compared to a net loss of $43.0 million, or $0.82 per share, in Q1 2024 [4][28]. - R&D expenses increased to $43.6 million in Q1 2025 from $29.9 million in Q1 2024, driven by heightened clinical activities [5][28]. - General and administrative expenses decreased slightly to $15.4 million in Q1 2025 from $16.1 million in Q1 2024 [8][28]. Pipeline and Upcoming Events - Kodiak plans to host an Investor R&D Update on July 16, 2025, to discuss scientific, clinical, and commercial perspectives across its pipeline [3]. - The company is advancing its investigational therapies, including Tarcocimab, KSI-501, and KSI-101, with ongoing Phase 3 studies and new clinical trial data expected [7][19][21]. Product Development - Tarcocimab is being studied in two Phase 3 trials: GLOW2 for diabetic retinopathy and DAYBREAK for wet AMD, with both studies utilizing an enhanced formulation [11][19]. - KSI-501 is designed to target both IL-6 and VEGF, with a focus on treating wet AMD and is currently in the DAYBREAK study [17][20]. - KSI-101 is being evaluated in a Phase 1b study for diabetic macular edema and macular edema secondary to inflammation, with plans for dual Phase 3 studies [21][22].
Kiora Pharmaceuticals Reports First Quarter Results; Initiating Two Phase 2 Trials for Treatment of Retinal Diseases; Cash and Short-term Investments Expected to Fund Operations into Late 2027
Newsfile· 2025-05-09 11:00
Core Insights - Kiora Pharmaceuticals reported its first quarter 2025 financial results and announced the initiation of two Phase 2 clinical trials for retinal diseases, with sufficient cash to fund operations into late 2027 [1][2][4] Financial Highlights - The company ended Q1 2025 with $24.1 million in cash, cash equivalents, and short-term investments, alongside $2.0 million in collaboration receivables and tax credits [4][6] - Kiora reported a net loss of $2.2 million for Q1 2025, a significant decrease from a net income of $13.4 million in Q1 2024, primarily due to a $16 million upfront payment recognized as collaboration revenue in the previous year [7] - Research and development (R&D) expenses for Q1 2025 were $2.5 million, up from $1.7 million in Q1 2024, driven by clinical trial activities [8] - General and administrative (G&A) expenses increased to $1.5 million in Q1 2025 from $1.3 million in Q1 2024 [9] Clinical Development Updates - Kiora is preparing to initiate enrollment in two Phase 2 clinical trials: the KLARITY study for KIO-104 targeting retinal inflammation and the ABACUS-2 study for KIO-301 focusing on retinitis pigmentosa [2][4] - The ABACUS-2 trial will involve 36 patients with ultra-low vision or no light perception due to retinitis pigmentosa, with a focus on demonstrating improvements in functional vision [3][4] - KIO-104 is a small molecule DHODH inhibitor aimed at treating inflammatory retinal diseases, with the first patient expected to be enrolled in Q2 2025 [5] Cash Management and Future Outlook - The company has extended its cash runway into late 2027, which is expected to cover anticipated data readouts for the KLARITY and ABACUS-2 trials [4][5] - Kiora has received $1.8 million in reimbursed R&D expenses from Laboratoires Théa, contributing to its financial stability [4][6]