Kodiak Sciences Inc. Q1 FY2020 earnings call

• Financial Position: Ended Q1 2020 with over $430 million in cash, cash equivalents, and marketable securities. Net loss of $24.4 million including non-cash expenses of ~$6 million. Cash runway sufficient to execute plans into 2022. • COVID-19 Impact: Minimal disruption to labs and clinical trials. Non-essential employees on remote work; labs operational. • Clinical Trials: DAZZLE study in wet AMD has <5% patient missed visits; clinical sites enrolling new patients. Delayed initiation of KSI-301 pivotal studies to September/October 2020 to optimize designs, engage regulators, and align with partners. • KSI-301 Pivotal Program: Upgraded to 2 Phase 3 studies in DME, 1 in wet AMD (DAZZLE), 1 in RVO, and 1 in non-proliferative DR. Prefer DME due to higher prevalence and unmet need. • Phase 1b Study: Data consistent, to provide update in July. Extended to 36 months of treatment and follow-up. • Board Additions: Added Dr. Taiyin Yang and Charlie Bancroft to board. • IP Portfolio: Received full registration of trademarks Kodiak and Kodiak Sciences. • KSI-501 Program: Accelerated GMP manufacturing of OG2072 protein for potential COVID-19 use and IND submission in 2021.

No detailed product segment financial performance with revenue contribution % discussed in the transcript.

• Delayed initiation of KSI-301 pivotal studies for DME and RVO to September/October 2020, with potential 1-2 quarter delay for NPDR study. • Cash runway sufficient to execute plans into 2022, including top-line readout of DAZZLE study. • 2022 Vision: Single BLA application covering key retinal indications. • Manufacturing: Working on scale-up and validation for BLA activities to service market post-launch.

• COVID-19 impact on clinical trial enrollment and conduct. • Competition from biosimilars in retinal markets. • Safety concerns related to new molecules like Beovu and their potential impact on Kodiak's market reception. • Potential enrollment challenges and their impact on study timelines and data integrity.

Q: Comment on market dynamics and competition from biosimilars for KSI-301.

A: Victor Perlroth discussed KSI-301's generation 2.0 profile with differentiated durability, aiming to compete for branded market share, potentially capturing Avastin's share and competing with Lucentis and EYLEA.

Q: Confidence in timing for completion of enrollment in AMD and potential interim analysis of data.

A: Victor Perlroth noted enrollment rates in February/March, expecting enrollment to increase, with no immediate need for interim analysis as the company is well-capitalized and focused on driving top-line data.

Q: Redosing criteria for Phase 3 trials and impact on POS.

A: Jason Ehrlich explained differences in redosing criteria between Phase 1b and Phase 3 studies, with DAZZLE tightening criteria, and DME and RVO studies having similar but adjusted criteria to ensure non-inferiority and durability.

Q: Sustainability of $6 million monthly burn rate and impact of lower enrollment rates.

A: Victor Perlroth stated burn rate will increase as studies ramp up, but is aligned with execution towards 2022 Vision. Lower enrollment rates could be managed by focusing on treatment-naïve patients and considering data from treatment-experienced patients for broader labeling.

Q: Concerns about inflammation and safety with new molecules, bispecific drug OG2072, and BLA filing for multiple indications.

A: Victor Perlroth addressed Beovu's safety concerns, KSI-301's favorable safety profile, acceleration of OG2072 for COVID-19, and plans to submit a single BLA for multiple retinal indications with EMA discussions ongoing.

Q: EMA feedback on pivotal study program design, RVO study breakdown, and missed visits impact.

A: Jason Ehrlich discussed EMA feedback considerations, RVO study stratification between BRVO and CRVO, and handling of missed visits through statistical methods to ensure study integrity.