Kodiak Sciences Inc

Previous wording

Kodiak's lead investigational medicine, tarcocimab, is a novel anti-VEGF antibody biopolymer conjugate under development for the treatment of high prevalence retinal vascular diseases including diabetic retinopathy, the leading cause of blindness in working-age patients in the developed world, and wet age-related macular degeneration, the leading cause of blindness in elderly patients in the developed world.

Current wording

Kodiak's lead investigational medicine, tarcocimab, is a novel anti-VEGF antibody biopolymer conjugate under development for the treatment of high prevalence retinal vascular diseases including diabetic retinopathy, the leading cause of blindness in working-age patients in the developed world, and wet age-related macular degeneration, the leading cause of blindness in elderly patients in the developed world. Tarcocimab is currently being studied in two Phase 3 clinical trials, GLOW2 in patients with diabetic retinopathy and DAYBREAK in patients with wet AMD. Both studies are actively enrolling patients.

Previous wording

KSI-501 is our second investigational medicine, a first-in-class anti-IL-6, VEGF-trap bispecific antibody biopolymer conjugate designed to inhibit both IL-6 mediated inflammation and VEGF-mediated angiogenesis and vascular permeability. KSI-501 is being developed for the treatment of high prevalence retinal vascular diseases to address the unmet needs of extended durability and targeting multiple disease biologies for differentiated efficacy. Phase 1b data for KSI-501 was presented in February 2024, and the Phase 3 DAYBREAK study of KSI-501 in wet AMD is scheduled to be actively screening patients in mid-2024.

Current wording

KSI-501 is our second investigational medicine, a first-in-class anti-IL-6, VEGF-trap bispecific antibody biopolymer conjugate designed to inhibit both IL-6 mediated inflammation and VEGF-mediated angiogenesis and vascular permeability. KSI-501 is being developed for the treatment of high prevalence retinal vascular diseases to address the unmet needs of extended durability and targeting multiple disease biologies for differentiated efficacy. Phase 1b data for KSI-501 was presented in February 2024, and the Phase 3 DAYBREAK study of KSI-501 in wet AMD is actively enrolling patients.

Previous wording

Additionally, Kodiak is developing a third product candidate, KSI-101, a novel anti-IL-6, VEGF-trap bispecific protein, the unconjugated protein portion of KSI-501. Kodiak intends to develop KSI-101 for the treatment of retinal inflammatory diseases, as currently there are no available intravitreal biologic therapies addressing the spectrum of inflammatory conditions of the retina.

Current wording

KSI-101, our third product candidate, is a novel anti-IL-6, VEGF-trap bispecific protein, the unconjugated protein portion of KSI-501. Kodiak is developing KSI-101 for the treatment of retinal inflammatory diseases, as currently there are no available intravitreal biologic therapies addressing the spectrum of inflammatory conditions of the retina. The Phase 1b APEX study of KSI-101 is actively enrolling patients.

Previous wording

Kodiak has expanded its early research pipeline of duet and triplet inhibitors that embed small molecules and other active pharmaceutical ingredients (“API”) in the biopolymer backbone to enable targeted, high drug-antibody ratio ("DAR") medicines. The diverse API’s are designed to be released over time to achieve targeted, multi-specific and tailored modulation of targeted biological pathways. The unique combination of high DAR and tailored therapeutic benefit offers potential for broad application to multifactorial ophthalmic and systemic diseases.

Current wording

Kodiak has expanded its early research pipeline of duet and triplet inhibitors that embed small molecules and other active pharmaceutical ingredients (“APIs”) in the biopolymer backbone to enable high drug-antibody ratio ("DAR") medicines. The diverse APIs are designed to be released over time to achieve targeted, multi-specific and tailored modulation of biological pathways. The unique combination of high DAR and tailored therapeutic benefit offers potential for broad application to multifactorial ophthalmic and systemic diseases.

Previous wording

The GLOW2 Phase 3 study in diabetic retinopathy (“DR”) has a similar design to the successful GLOW1 Phase 3 study with the benefit of an additional, third monthly loading dose (weeks 0, 4, and 8). We recently announced that the first patients were treated in the GLOW2 study and that our goal is to complete enrollment before the end of this year.

Current wording

Tarcocimab pivotal program: We previously announced that first patients were treated in the GLOW2 Phase 3 study of tarcocimab in diabetic retinopathy (“DR”).

Previous wording

The Phase 3 GLOW2 study is a prospective, randomized, double-masked, multi-center pivotal superiority study designed to evaluate the efficacy and safety of tarcocimab tedromer in treatment-naïve patients with diabetic retinopathy (DR). Patients are randomized 1:1 and receive tarcocimab via intravitreal injection at baseline, Week 4, Week 8, Week 20 and Week 44. The primary endpoint is the proportion of eyes improving ≥2 steps on Diabetic Retinopathy Severity Scale (DRSS) from baseline at Week 48. Additional outcome measures include the proportion of eyes developing a sight threatening complication of diabetic retinopathy and the proportion of eyes improving ≥3 steps on DRSS from baseline at Week 48.

Current wording

The Phase 3 GLOW2 study is a prospective, randomized, double-masked, multi-center pivotal superiority study designed to evaluate the efficacy and safety of tarcocimab tedromer in treatment-naïve patients with DR. Patients are randomized 1:1 to receive either sham injections or tarcocimab via intravitreal injection at baseline, Week 4, Week 8, Week 20 and Week 44. The primary endpoint is the proportion of eyes improving ≥2 steps on Diabetic Retinopathy Severity Scale (“DRSS”) from baseline at Week 48. Additional outcome measures include the proportion of eyes developing a sight threatening complication of diabetic retinopathy and the proportion of eyes improving ≥3 steps on DRSS from baseline at Week 48.

Previous wording

We also announced our intention to study tarcocimab as a second investigational arm in the KSI-501 Phase 3 DAYBREAK study to evaluate its durability, strengthen its competitive position in wet AMD and bolster its ex-US regulatory dossier. We are operationalizing towards DAYBREAK study activation in mid-2024.

Current wording

We also announced our intention to study tarcocimab as a second investigational arm in the Phase 3 DAYBREAK study to assess its 6-month durability potential, strengthen its competitive position in wet AMD and bolster its regulatory application package. Treatment-naïve wet AMD patients randomized to tarcocimab will receive individualized dosing every 4 to 24 weeks on an as needed basis following four monthly loading doses. Patients randomized to aflibercept will be dosed per its label.

Previous wording

KSI-501 clinical program: In the first quarter of 2024 we shared the Phase 1 study results of KSI-501 in patients with diabetic macular edema (“DME”) at the Angiogenesis, Exudation, and Degeneration 2024 Virtual Meeting. The Phase 1 study demonstrated that repeated monthly dosing of KSI-501 was safe and well tolerated and achieved clinically meaningful and sustained visual acuity gains and fluid reduction in patients.

Current wording

KSI-501 clinical program: We completed the Phase 1 study of KSI-501 in patients with diabetic macular edema (“DME”) in the first quarter of 2024 and shared the study results at the Angiogenesis, Exudation, and Degeneration 2024 Virtual Meeting. The results of the Phase 1 study demonstrated that repeated monthly dosing of KSI-501 was safe and well tolerated and achieved clinically meaningful and sustained visual acuity gains and fluid reductions in patients with diabetic macular edema.

Previous wording

KSI-101 clinical program: KSI-101 is a novel, potent and high-strength bispecific protein targeting IL-6 and VEGF. In the first quarter of 2024 we announced our intention to develop KSI-101 for patients who have retinal fluid and inflammation. With KSI-101, we are seeking to develop an intravitreal biologic therapy whose commercial opportunity sits outside of today’s anti-VEGF retina market. We have recently obtained supportive FDA feedback on the pivotal study program for KSI-101. Two pivotal clinical studies will be required, both with 16-week primary endpoints. We are on track to initiate enrollment for a dose-finding Phase 1b APEX study in June 2024 to evaluate the safety and tolerability and to identify two dose levels to progress into dual Phase 2b/3 studies (PEAK and PINNACLE) which we hope to initiate later in 2024.

Current wording

KSI-101 clinical program: KSI-101 is a novel, potent and high-strength (100 mg/mL) bispecific protein targeting IL-6 and VEGF. With KSI-101, we are seeking to develop an intravitreal biologic therapy whose commercial opportunity sits outside of today’s anti-VEGF retinal vascular disease market.

Previous wording

Recent scientific presentations: We presented a breadth of data on our early- and late-phase retina pipeline at the Association for Research in Vision and Ophthalmology (ARVO) 2024 Annual Meeting. Our presentations included clinical and non-clinical data on our ABC Platform investigational medicines tarcocimab and KSI-501, and we highlighted progress on our duet and triplet platform including discovery and characterization of novel small molecules and biologics.

Current wording

At the Association for Research in Vision and Ophthalmology (“ARVO”) 2024 Annual Meeting, we presented a breadth of data on our early- and late-phase retina pipeline. Our presentations included clinical and non-clinical data on our ABC Platform investigational medicines tarcocimab and KSI-501, and we highlighted progress on our duet and triplet platform including discovery and characterization of novel small molecules and biologics.

Previous wording

Tarcocimab program expenses decreased $20.2 million during the three months ended March 31, 2024 as compared to the same period in 2023, primarily driven by reduced clinical activities for the tarcocimab development program, partially offset by increased expense related to the Ursus commercial scale manufacturing facility.

Current wording

Tarcocimab program expenses decreased $25.5 million and $45.7 million during the three and six months ended June 30, 2024 as compared to the same periods in 2023, primarily driven by reduced manufacturing and clinical activities for the tarcocimab development program.

Previous wording

KSI-501 program expenses increased $1.4 million during the three months ended March 31, 2024 as compared to the same period in 2023, due to increased manufacturing activities in the current quarter.

Current wording

KSI-501 and KSI-101 program expenses increased $0.1 million and $1.6 million during the three and six months ended June 30, 2024 as compared to the same periods in 2023, due to increased manufacturing activities, offset by decreased clinical costs from the completion of the Phase 1 clinical study of KSI-501.

Previous wording

ABC Platform and other program expenses decreased $1.5 million during the three months ended March 31, 2024 as compared to the same period in 2023, due to fewer biopolymer manufacturing activities in the current quarter.

Current wording

ABC Platform and other program expenses decreased $2.0 million and $3.5 million during the three and six months ended June 30, 2024 as compared to the same periods in 2023, due to fewer biopolymer manufacturing runs in the current period.

Previous wording

Payroll and personnel expenses decreased $5.8 million during the three months ended March 31, 2024 as compared to the same period in 2023. The decrease in payroll and personnel expenses was primarily driven by forfeitures related to stock-based compensation expense.

Current wording

Payroll and personnel expenses decreased $5.6 million and $11.3 million during the three and six months ended June 30, 2024 as compared to the same periods in 2023. The decrease in payroll and personnel expenses was primarily driven by forfeitures related to stock-based compensation expense.

Previous wording

Facilities and other research and development expenses decreased $0.6 million during the three months ended March 31, 2024 as compared to the same period in 2023, primarily due to decreased expense related to our lease obligations as a result of currency fluctuations.

Current wording

Facilities and other research and development expenses decreased $1.5 million and $2.1 million during the three and six months ended June 30, 2024 as compared to the same periods in 2023, primarily driven by reduced costs for digital transformation activities as well as currency fluctuations in the revaluation of our lease and capital obligations.

Previous wording

General and administrative expenses decreased $2.0 million during the three months ended March 31, 2024 as compared to the same period in 2023. The decrease was primarily driven by stock-based compensation expense.

Current wording

General and administrative expenses decreased $2.4 million and $4.4 million during the three and six months ended June 30, 2024 as compared to the same periods in 2023. The decrease was primarily driven by stock-based compensation expense related to previously issued awards becoming fully vested in prior periods.

Previous wording

We have funded our operations primarily through the sale and issuance of common stock, redeemable convertible preferred stock, convertible notes, warrants and the sale of royalties. As of March 31, 2024, we had cash and cash equivalents of $245.9 million. We believe that our current cash and cash equivalents will be sufficient to support our current and planned operations into 2026.

Current wording

We have funded our operations primarily through the sale and issuance of common stock, redeemable convertible preferred stock, convertible notes, warrants and the sale of royalties. As of June 30, 2024, we had cash and cash equivalents of $219.2 million. We believe that our current cash and cash equivalents will be sufficient to support our current and planned operations into 2026.

Previous wording

We have incurred net losses since our inception. For the three months ended March 31, 2024, we had net loss of $43.0 million, of which $18.4 million related to non-cash stock-based compensation expense. We expect to continue to incur additional losses in future periods. As of March 31, 2024, we had an accumulated deficit of $1,195.6 million. We believe that the cash and cash equivalents will be sufficient to meet our anticipated operating and capital expenditure requirements at least 12 months following the date of this Quarterly Report on Form 10-Q.

Current wording

We have incurred net losses since our inception. For the three and six months ended June 30, 2024, we had net loss of $45.1 million and $88.2 million, of which $18.4 million and $36.8 million related to non-cash stock-based compensation expense, respectively. We expect to continue to incur additional losses in future periods. As of June 30, 2024, we had an accumulated deficit of $1,240.7 million. We believe that the cash and cash equivalents will be sufficient to meet our anticipated operating and capital expenditure requirements at least 12 months following the date of this Quarterly Report on Form 10-Q.

Previous wording

Net cash used in operating activities was $39.6 million for the three months ended March 31, 2024, based on operational spend of $17.8 million and changes in operating assets and liabilities of $21.8 million.

Current wording

Net cash used in operating activities was $66.1 million for the six months ended June 30, 2024, based on operational spend of $37.7 million and changes in operating assets and liabilities of $28.4 million.

Previous wording

During the three months ended March 31, 2024, there were no material changes to our critical accounting policies as reported in our Annual Report on Form 10-K for the year ended December 31, 2023, which was filed with the SEC on March 28, 2024, except as otherwise described in Note 2 to our unaudited condensed consolidated financial statements included in this report.

Current wording

During the six months ended June 30, 2024, there were no material changes to our critical accounting policies as reported in our Annual Report on Form 10-K for the year ended December 31, 2023, which was filed with the SEC on March 28, 2024, except as otherwise described in Note 2 to our unaudited condensed consolidated financial statements included in this report.