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Final APEX Phase 1b Clinical Results for Kodiak's KSI-101 in Macular Edema Secondary to Inflammation to be Presented at Angiogenesis 2026
Prnewswire· 2026-02-04 12:00
Core Viewpoint - Kodiak Sciences Inc. is set to present first-time end-of-study clinical results from the Phase 1b APEX study for KSI-101 at the Angiogenesis annual meeting, highlighting the drug's potential as a first-line therapy for macular edema secondary to inflammation (MESI) [4]. Company Overview - Kodiak Sciences Inc. is a precommercial biotechnology company focused on developing transformative therapeutics for retinal diseases, with a commitment to addressing leading causes of blindness globally [9]. - The company is advancing a portfolio of three late-stage clinical programs, including KSI-101, which targets a new market segment separate from the established anti-VEGF market [6][9]. Clinical Study Insights - The APEX study has shown that KSI-101 provides significant visual and anatomical improvements in patients with MESI, regardless of the inflammation's location or specific etiology [4][7]. - The study has completed enrollment and demonstrated that KSI-101 is well tolerated, with meaningful treatment responses observed in the MESI population [7]. - The top two dose levels from the APEX study have been selected for advancement into the Phase 3 PEAK and PINNACLE studies, which are currently enrolling patients [8]. Drug Profile - KSI-101 is a bispecific protein targeting IL-6 and VEGF, developed for patients with MESI, a condition characterized by retinal fluid and visual impairment due to inflammation [5]. - Currently, there are no available intravitreal biologic therapies addressing the spectrum of MESI diseases, indicating a significant market opportunity for KSI-101 [6]. Upcoming Events - The presentation of the APEX study results will be available on Kodiak's website at the start of the Angiogenesis meeting on February 7, 2026 [3].
Kodiak Sciences (NasdaqGM:KOD) FY Earnings Call Presentation
2026-01-12 21:30
Kodiak®, Kodiak Sciences®, ABC®, ABC Platform , and the Kodiak logo are registered trademarks or trademarks of Kodiak Sciences Inc. in various global jurisdictions. THE OPHTHALMOLOGY MEDICINES COMPANY 44th Annual J.P. Morgan Healthcare Conference January 12, 2026 1 Forward-Looking Statements This presentation may contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and other federal securities laws, including statements regarding Kodiak's plans, commi ...
Kodiak Sciences to Present at 44th Annual J.P. Morgan Healthcare Conference
Prnewswire· 2026-01-08 01:19
Core Insights - Kodiak Sciences Inc. is a precommercial biotechnology company focused on developing transformative therapeutics for retinal diseases [3] Company Overview - Kodiak Sciences is dedicated to researching, developing, and commercializing next-generation retinal medicines aimed at preventing and treating leading causes of blindness globally [3] - The company is developing a portfolio of three late-stage clinical programs targeting the $15 billion anti-VEGF marketplace [3] - Two drug candidates, Tarcocimab and KSI-501, are in Phase 3 studies with topline data readouts expected in 1Q 2026 and 3Q 2026 respectively [3] - KSI-101, a bispecific protein, is also in two Phase 3 studies with topline data readouts expected in 4Q 2026 and 2Q 2027 [3] Upcoming Events - Senior management will present at the 44th Annual J.P. Morgan Healthcare Conference on January 12, 2026, at 1:30 p.m. Pacific Time [1] - A live webcast of the presentation will be available on Kodiak's website and will remain accessible for a limited time after the event [2]
Kodiak Sciences Announces Closing of $184 Million Public Offering of Common Stock including Full Exercise of Underwriters' Option to Purchase Additional Shares
Prnewswire· 2025-12-19 01:26
Core Insights - Kodiak Sciences Inc. successfully closed a public offering of 8,000,000 shares at a price of $23.00 per share, generating approximately $184 million in gross proceeds before expenses [1][3]. Company Overview - Kodiak Sciences is a precommercial biotechnology company focused on developing transformative therapeutics for retinal diseases, utilizing its proprietary ABC® Platform for next-generation retinal medicines [5]. Financial Position - The completion of the public offering strengthens Kodiak's financial position as it prepares for important Phase 3 topline readouts for its late-stage clinical assets: KSI-101, KSI-501, and tarcocimab [3]. Clinical Programs - Kodiak is advancing three late-stage clinical programs, with tarcocimab and KSI-501 in two BLA-facing Phase 3 studies for retinal vascular diseases, and KSI-101 being explored in two Phase 3 studies for Macular Edema Secondary to Inflammation (MESI) [5]. Underwriters - The offering was managed by J.P. Morgan, Jefferies, Evercore ISI, and UBS Investment Bank as joint book-running managers [2].
Kodiak Sciences Announces Pricing of Upsized Public Offering of Common Stock
Prnewswire· 2025-12-17 03:55
Core Viewpoint - Kodiak Sciences Inc. has announced an upsized underwritten public offering of 6,956,522 shares at a price of $23.00 per share, aiming to raise approximately $160 million in gross proceeds before expenses [1]. Company Overview - Kodiak Sciences is a precommercial biotechnology company focused on retinal therapeutics, utilizing its ABC® Platform to develop next-generation retinal medicines aimed at preventing and treating blindness [5]. - The company is currently advancing three late-stage clinical programs, including Tarcocimab and KSI-501 in Phase 3 studies for retinal vascular diseases, and KSI-101 in Phase 3 studies for Macular Edema Secondary to Inflammation [5]. Offering Details - The public offering is expected to close on or about December 18, 2025, subject to customary closing conditions [1]. - Kodiak Sciences has granted underwriters a 30-day option to purchase an additional 1,043,478 shares at the public offering price [1]. - The offering is conducted under a shelf registration statement previously filed with the SEC, which was declared effective on June 2, 2023 [3].
Kodiak Sciences Announces Proposed Public Offering of Common Stock
Prnewswire· 2025-12-15 21:01
Core Viewpoint - Kodiak Sciences Inc. has initiated an underwritten public offering of 6,000,000 shares of its common stock, with an option for underwriters to purchase an additional 900,000 shares [1][2]. Company Overview - Kodiak Sciences is a precommercial biotechnology company focused on retinal therapeutics, aiming to develop transformative treatments for leading causes of blindness globally [5]. - The company utilizes its ABC® Platform, which integrates protein-based and chemistry-based therapies, to advance its research and development efforts [5]. - Kodiak is currently developing three late-stage clinical programs, including Tarcocimab and KSI-501 in Phase 3 studies for retinal vascular diseases, and KSI-101 for Macular Edema Secondary to Inflammation [5]. Offering Details - The proposed public offering is subject to market conditions, and there are no guarantees regarding its completion or the final terms [1]. - The shares are being offered under a shelf registration statement that was declared effective by the SEC on June 2, 2023 [3].
Kodiak Sciences to Present at Upcoming Investor Conferences
Prnewswire· 2025-11-12 22:48
Core Insights - Kodiak Sciences Inc. is a precommercial biotechnology company focused on developing transformative therapeutics for retinal diseases [2][4] - The company is advancing three late-stage clinical programs targeting the $15 billion anti-VEGF market [2] - Recent data from the APEX study indicates that 90% of patients achieved absence of intraretinal and subretinal fluid through week 20 in macular edema secondary to inflammation [4][5] Company Overview - Kodiak Sciences is committed to researching, developing, and commercializing next-generation retinal medicines to prevent and treat leading causes of blindness globally [2] - The company's ABC Platform utilizes molecular engineering to integrate protein-based and chemistry-based therapies [2] Upcoming Events - CEO Victor Perlroth will present at the Jefferies Global Healthcare Conference on November 17, 2025, and at the Evercore Healthcare Conference on December 3, 2025 [5]
New data for Kodiak's KSI-101 from the APEX study reinforce its clinically meaningful vision gains and rapid retinal drying in macular edema secondary to inflammation (MESI)
Prnewswire· 2025-09-15 11:00
Core Insights - Kodiak Sciences Inc. announced new data from the APEX study of KSI-101, a novel therapy for macular edema secondary to inflammation (MESI), presented at the Retina Society Annual Scientific Meeting [1][2] Group 1: Study Findings - The APEX Phase 1b study showed that patients with MESI experienced clinically meaningful gains in best-corrected visual acuity (BCVA) and rapid retinal drying by Week 12 [2][5] - In the study, the proportion of patients achieving a 15-letter gain in BCVA was 31% at the 2.5 mg dose, 62% at the 5 mg dose, and 54% at the 10 mg dose [5] - The mean change in BCVA from baseline to Week 12 was +8.8 letters for 2.5 mg, +10.7 letters for 5 mg, and +12.1 letters for 10 mg [5] - Patients with diabetic macular edema (DME) also showed significant visual and anatomical improvements, gaining an average of 12.0 letters and reducing retinal thickness by 157 microns by Week 24 [5] Group 2: Mechanism and Safety - KSI-101 is a bispecific antibody targeting interleukin-6 (IL-6) and vascular endothelial growth factor (VEGF), designed to treat MESI [4][10] - The therapy demonstrated a favorable safety profile, being well tolerated in both MESI and DME patients [6][12] - The drying effect of KSI-101 was reported to be comparable or superior to existing treatments like Ozurdex, without associated side effects [7] Group 3: Future Developments - Ongoing Phase 3 studies, PEAK and PINNACLE, are actively enrolling patients to further evaluate KSI-101 at the 5 mg and 10 mg dose levels [8][14] - The studies aim to cover a wide spectrum of MESI patients, with PEAK focusing on more severe cases and PINNACLE on milder cases [14] - Topline data readouts for KSI-101 are expected in late 2026 or early 2027, indicating a significant market opportunity for the treatment of MESI [17]
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].