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Kodiak (KOD) Q1 Loss Narrower Than Expected, Pipeline in Focus
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Kodiak Sciences Inc. (KOD - Free Report) reported first-quarter 2024 loss per share of 82 cents, narrower than the Zacks Consensus Estimate of a loss of $1.09. The company had incurred a loss of $1.35 per share in the year-ago quarter.
Currently, KOD does not have any approved products in its portfolio. As a result, it is yet to generate revenues.
Quarter in Detail
Research and development expenses were $29.9 million in the reported quarter, down 47% year over year. The decrease was mainly due to the reduction in expenses owing to the conclusion of some clinical studies on its lead pipeline candidate, tarcocimab.
General and administrative expenses were $16.1 million, down 11% on a year-over-year basis, primarily due to lower non-cash stock-based compensation expenses.
As of Mar 31, 2024, Kodiak had cash, cash equivalents and marketable securities worth $245.9 million compared with $285.5 million as of Dec 31, 2023. The company believes that its current cash balance is enough to support its present and planned operations into 2026.
Year to date, shares of KOD have gained 23% against the industry’s decline of 4.2%.
Image Source: Zacks Investment Research
Pipeline Updates
Toward the end of last year, the company announced positive top-line results from its phase III GLOW1 study evaluating tarcocimab in moderately severe to severe non-proliferative diabetic retinopathy (NPDR). The GLOW study met its primary endpoint and all key secondary endpoints with high statistical significance.
Building on the success of the GLOW1 study, KOD initiated the pivotal phase III GLOW2 study in the first quarter of 2024 to evaluate tarcocimab in diabetic retinopathy, which is actively enrolling patients. The success of the GLOW2 study is expected to serve as the basis for a regulatory filing for tarcocimab for all three indications, such as wet age-related macular degeneration (wet AMD), retinal vein occlusion and NPDR, seeking its approval.
Kodiak recently reported that it has dosed the first patient in the GLOW2 study. Enrollment in the study is expected to be completed by the end of 2024.
Also, during the first quarter, the company shared positive results from an early-stage study of its second clinical candidate, KSI-501, in patients with diabetic macular edema at a medical conference. KSI-501 is a dual inhibitor Trap-Antibody-Fusion bioconjugate molecule.
Per the phase I data readout, repeated monthly dosing of KSI-501 resulted in clinically meaningful and sustained visual acuity gains and fluid reduction in patients. The candidate was also observed to be generally safe and overall well-tolerated.
Kodiak is currently gearing up to initiate a phase III DAYBREAK study on KSI-501 to evaluate its efficacy, durability and safety in wet AMD around mid-2024.
Please note that the company plans to study tarcocimab as a second investigational arm in the DAYBREAK study to treat wet AMD, with KSI-501 being the first investigational arm. This is expected to support regulatory filings for tarcocimab outside the United States in wet AMD.
Kodiak is also looking to initiate a clinical program to develop its third investigational candidate, KSI-101, for patients who have retinal fluid and inflammation. KSI-101 is the company’s novel, potent and high-strength bispecific protein targeting IL-6 and VEGF.
KOD recently gained alignment with the FDA regarding the pivotal study program for KSI-101, comprising two pivotal studies, a phase Ib APEX dose-finding study and dual phase IIb/III (PEAK and PINNACLE) studies. Both pivotal studies will evaluate the candidate over a 16-week treatment period.
Kodiak anticipates beginning enrolment in the APEX study in June 2024 for evaluating the safety and tolerability and identifying two dose levels of KSI-101 to progress into late-stage development. The phase IIb/III studies are expected to be initiated later in 2024.
The presence of other clinical-stage pipeline candidates is particularly encouraging as it assures investors that the company’s entire growth prospect is not just dependent on the success of its tarcocimab program.
In the past 30 days, the Zacks Consensus Estimate for Ligand’s 2024 earnings per share has remained constant at $4.56. During the same time frame, the consensus estimate for 2025 earnings per share has remained constant at $5.27. Year to date, shares of LGND have gained 20.1%.
Ligand beat estimates in each of the trailing four quarters, delivering an average surprise of 56.02%.
In the past 30 days, estimates for ANI Pharmaceuticals’ 2024 earnings per share have risen from $4.43 to $4.44. Meanwhile, during the same period, the estimate for ANI Pharmaceuticals’ 2025 earnings per share has remained constant at $5.04. Year to date, shares of ANIP have climbed 17.6%.
ANI Pharmaceuticals beat estimates in each of the last four quarters, delivering an average surprise of 53.90%.
In the past 30 days, the Zacks Consensus Estimate for Annovis’ 2024 loss per share has narrowed from $3.35 to $2.93. During the same period, the estimate for Annovis’ 2025 loss per share has narrowed from $2.82 to $2.70. Year to date, shares of ANVS have plunged 53.4%.
ANVS beat estimates in three of the trailing four quarters and missed once, delivering an average negative surprise of 1.39%.
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Kodiak (KOD) Q1 Loss Narrower Than Expected, Pipeline in Focus
Kodiak Sciences Inc. (KOD - Free Report) reported first-quarter 2024 loss per share of 82 cents, narrower than the Zacks Consensus Estimate of a loss of $1.09. The company had incurred a loss of $1.35 per share in the year-ago quarter.
Currently, KOD does not have any approved products in its portfolio. As a result, it is yet to generate revenues.
Quarter in Detail
Research and development expenses were $29.9 million in the reported quarter, down 47% year over year. The decrease was mainly due to the reduction in expenses owing to the conclusion of some clinical studies on its lead pipeline candidate, tarcocimab.
General and administrative expenses were $16.1 million, down 11% on a year-over-year basis, primarily due to lower non-cash stock-based compensation expenses.
As of Mar 31, 2024, Kodiak had cash, cash equivalents and marketable securities worth $245.9 million compared with $285.5 million as of Dec 31, 2023. The company believes that its current cash balance is enough to support its present and planned operations into 2026.
Year to date, shares of KOD have gained 23% against the industry’s decline of 4.2%.
Image Source: Zacks Investment Research
Pipeline Updates
Toward the end of last year, the company announced positive top-line results from its phase III GLOW1 study evaluating tarcocimab in moderately severe to severe non-proliferative diabetic retinopathy (NPDR). The GLOW study met its primary endpoint and all key secondary endpoints with high statistical significance.
Building on the success of the GLOW1 study, KOD initiated the pivotal phase III GLOW2 study in the first quarter of 2024 to evaluate tarcocimab in diabetic retinopathy, which is actively enrolling patients. The success of the GLOW2 study is expected to serve as the basis for a regulatory filing for tarcocimab for all three indications, such as wet age-related macular degeneration (wet AMD), retinal vein occlusion and NPDR, seeking its approval.
Kodiak recently reported that it has dosed the first patient in the GLOW2 study. Enrollment in the study is expected to be completed by the end of 2024.
Also, during the first quarter, the company shared positive results from an early-stage study of its second clinical candidate, KSI-501, in patients with diabetic macular edema at a medical conference. KSI-501 is a dual inhibitor Trap-Antibody-Fusion bioconjugate molecule.
Per the phase I data readout, repeated monthly dosing of KSI-501 resulted in clinically meaningful and sustained visual acuity gains and fluid reduction in patients. The candidate was also observed to be generally safe and overall well-tolerated.
Kodiak is currently gearing up to initiate a phase III DAYBREAK study on KSI-501 to evaluate its efficacy, durability and safety in wet AMD around mid-2024.
Please note that the company plans to study tarcocimab as a second investigational arm in the DAYBREAK study to treat wet AMD, with KSI-501 being the first investigational arm. This is expected to support regulatory filings for tarcocimab outside the United States in wet AMD.
Kodiak is also looking to initiate a clinical program to develop its third investigational candidate, KSI-101, for patients who have retinal fluid and inflammation. KSI-101 is the company’s novel, potent and high-strength bispecific protein targeting IL-6 and VEGF.
KOD recently gained alignment with the FDA regarding the pivotal study program for KSI-101, comprising two pivotal studies, a phase Ib APEX dose-finding study and dual phase IIb/III (PEAK and PINNACLE) studies. Both pivotal studies will evaluate the candidate over a 16-week treatment period.
Kodiak anticipates beginning enrolment in the APEX study in June 2024 for evaluating the safety and tolerability and identifying two dose levels of KSI-101 to progress into late-stage development. The phase IIb/III studies are expected to be initiated later in 2024.
The presence of other clinical-stage pipeline candidates is particularly encouraging as it assures investors that the company’s entire growth prospect is not just dependent on the success of its tarcocimab program.
Kodiak Sciences Inc. Price and EPS Surprise
Kodiak Sciences Inc. price-eps-surprise | Kodiak Sciences Inc. Quote
Zacks Rank and Stocks to Consider
Kodiak currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks from the drug/biotech industry are Ligand Pharmaceuticals (LGND - Free Report) , ANI Pharmaceuticals (ANIP - Free Report) and Annovis Bio (ANVS - Free Report) . While LGND sports a Zacks Rank #1 (Strong Buy), ANIP and ANVS carry a Zacks Rank #2 (Buy) each at present. You can see the complete list of today’s Zacks #1 Rank stocks here.
In the past 30 days, the Zacks Consensus Estimate for Ligand’s 2024 earnings per share has remained constant at $4.56. During the same time frame, the consensus estimate for 2025 earnings per share has remained constant at $5.27. Year to date, shares of LGND have gained 20.1%.
Ligand beat estimates in each of the trailing four quarters, delivering an average surprise of 56.02%.
In the past 30 days, estimates for ANI Pharmaceuticals’ 2024 earnings per share have risen from $4.43 to $4.44. Meanwhile, during the same period, the estimate for ANI Pharmaceuticals’ 2025 earnings per share has remained constant at $5.04. Year to date, shares of ANIP have climbed 17.6%.
ANI Pharmaceuticals beat estimates in each of the last four quarters, delivering an average surprise of 53.90%.
In the past 30 days, the Zacks Consensus Estimate for Annovis’ 2024 loss per share has narrowed from $3.35 to $2.93. During the same period, the estimate for Annovis’ 2025 loss per share has narrowed from $2.82 to $2.70. Year to date, shares of ANVS have plunged 53.4%.
ANVS beat estimates in three of the trailing four quarters and missed once, delivering an average negative surprise of 1.39%.