Kodiak Sciences announces second quarter 2020 financial results

Kodiak Sciences Inc., a biopharmaceutical company committed to researching, developing and commercializing transformative therapeutics to treat high prevalence retinal diseases, today reported business highlights and financial results for the second quarter ended June 30, 2020.

“We have made strong progress across the entire company this quarter— clinical, manufacturing, research and corporate. I am very proud of how our growing Kodiak community has continued to execute in the midst of the ongoing global pandemic,” said Victor Perlroth, MD, Chief Executive Officer of Kodiak. “There is a high unmet need for a new foundational therapy in the diseases we are exploring with KSI-301, namely wet age-related macular degeneration (wet AMD), diabetic macular edema (DME) and retinal vein occlusion (RVO). With strong physician and patient enthusiasm for KSI-301 and its emerging durability profile, enrollment has been brisk in our DAZZLE wet AMD pivotal study, and we successfully began recruitment in Europe in the second quarter. US enrollment in DAZZLE is near its conclusion. Building on the strong Phase 1b data that well-characterize KSI-301 in treatment-naïve patients and show the potential for many patients to achieve every five- or six-month dosing, we have conviction in the designs of our pivotal studies in DME and RVO and are focused on initiating recruitment. Our ambitious KSI-301 development plan which we call our ‘2022 Vision’ will, if successful, enable a single multi-indication BLA filing in 2022 and commercialization in 2023. We remain on track for achieving our vision from a timeline perspective and from a data perspective as well, with the 44-week KSI-301 Phase 1b results recently presented at ASRS continuing to demonstrate differentiated treatment durability alongside standard-of-care level safety and efficacy. As competing programs-in-development continue to present their own on-going safety, efficacy and durability data, we see the real possibility emerging for KSI-301 to achieve our aspirational goal as the ‘product for everyone’ with retinal vascular diseases. At the same time, we are making strides towards Kodiak as a global center of excellence for high-science retinal medicines development, with our growing pipeline of bispecific and triplet inhibitors built on our ABC Platform continuing to advance. Given the growing prevalence of sight-threatening diseases and the demographics of aging and diabetes globally, Kodiak’s ten-plus years of focus and dedication to retina is allowing us to begin accelerating our impact. With all these efforts in progress and a strong cash runway from our equity and royalty financings, we enter the third quarter with a growing and resilient team who continue to step-in daily for patients. We applaud their passion and look forward to continued execution in this second half of 2020.”

Optimized Pivotal Study Program
We have finalized the design of our pivotal study program. We intend to conduct two Phase 3 studies in DME (GLEAM and GLIMMER) to provide the mutually confirmatory studies required by FDA for initial demonstration of safety and efficacy, one study in wet AMD (our ongoing DAZZLE study), one study in RVO (BEACON), and one study in non-proliferative diabetic retinopathy without DME (GLOW). Each study protocol design has been optimized based on Phase 1b data and experience and will include the same patient populations, tighter dosing interval ranging, tighter disease control, decreased subjectivity and high statistical power for non-inferiority.

DAZZLE Study Progress
Recruitment into our DAZZLE pivotal study in wet AMD was robust. As of July 30, 2020, over 375 patients have been enrolled in DAZZLE. The impact of the pandemic on patient retention and missed visits has been minimal, with few missed visits to date. EU patient enrollment commenced in June 2020. The Independent Data Monitoring Committee responsible for safeguarding the interests of DAZZLE study participants, assessing safety during the trial, and monitoring overall study conduct met in May 2020 and recommended that DAZZLE should continue without modification.

Phase 1b Data Presentation
Updated safety and efficacy results from our ongoing Phase 1b trial of KSI-301 in patients with treatment naïve wet AMD, DME, or RVO were presented at the American Society of Retina Specialists (ASRS) 2020 Virtual Annual Meeting in July 2020. We believe the data continue to support the differentiated “anti-VEGF Generation 2.0” profile of KSI-301.

Commercial Manufacturing Progress
We negotiated a long-term agreement with Lonza for the manufacture of KSI-301. This agreement will provide Kodiak with a custom-built bioconjugation facility with a capacity to supply millions of doses per year. With construction targeted for completion in 2021, the Lonza-Kodiak Ibex facility will provide Kodiak with the facility needed for commercial-scale manufacturing of KSI-301. The timing of this expanded partnership is designed to support Kodiak’s targeted BLA submission timeline in 2022, and the scale is designed to support KSI-301’s potential to achieve significant market share, if approved, as a new first-line agent designed to improve outcomes for patients with common and serious retinal vascular diseases.

Completed Lease Agreement for Kodiak’s New Corporate Headquarters
We have leased approximately 82,662 square feet located at 1200 Page Mill Road, Palo Alto, California and approximately 72,812 square feet located at 1250 Page Mill Road, Palo Alto, California. These newly leased buildings will serve as Kodiak’s corporate headquarters for office and laboratory space. We also leased approximately 10,750 square feet at Rottenstrasse 5 in Visp, Switzerland, for manufacturing support and supervision.

Expected Upcoming Events/Milestones in 2020

• Initiate two pivotal Phase 3 randomized head-to-head studies of KSI-301 against aflibercept in treatment naïve Diabetic Macular Edema patients (GLEAM and GLIMMER)
• Initiate one pivotal Phase 3 randomized head-to-head study of KSI-301 against aflibercept in treatment naïve Retinal Vein Occlusion patients (BEACON)
• (Potential) Initiate one pivotal Phase 3 randomized study of KSI-301 against sham in non-proliferative Diabetic Retinopathy without DME patients (GLOW)
• (Potential) Complete enrollment in DAZZLE pivotal Phase 2b/3 randomized head-to-head study of KSI-301 against aflibercept in treatment naïve wet macular degeneration patients.

Second Quarter 2020 Financial Results

Cash Position
Kodiak ended the second quarter of 2020 with $417.1 million of cash, cash equivalents and marketable securities. Based on the company’s current cash position, Kodiak estimates having sufficient funds to execute on current operating plans into 2022.

Net Loss
The net loss for the second quarter of 2020 was $26.0 million, or $0.58 per share on both a basic and diluted basis, as compared to a net loss of $11.4 million, or $0.31 per share on both a basic and diluted basis, for the second quarter of 2019.

R&D Expenses
Research and development (R&D) expenses were $20.6 million for the second quarter of 2020, as compared to $8.8 million for the second quarter of 2019.

G&A Expenses
General and administrative (G&A) expenses were $6.2 million for the second quarter of 2020, as compared to $3.0 million for the second quarter of 2019.

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