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Should You Hold Kodiak Sciences (KOD) Stock in Your Portfolio?
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Kodiak Sciences (KOD - Free Report) , a clinical-stage company, is focused on developing novel therapeutics to treat chronic, high-prevalence retinal diseases, which are the major causes of blindness. The company’s proprietary antibody biopolymer conjugate (ABC) platform is designed to maintain potent and effective drug levels in ocular tissues longer than the currently marketed biologic medicines for treating retinal diseases.
Toward the end of last year, Kodiak Sciences decided to reboot the development program of its lead candidate, tarcocimab (a novel anti-VEGF ABC), after witnessing positive top-line results from its phase III GLOW study evaluating the same in moderately severe to severe non-proliferative diabetic retinopathy (NPDR).
The company had previously reported the success of its phase III DAYLIGHT and BEACON studies evaluating tarcocimab in patients with wet AMD and retinal vein occlusion (RVO), respectively.The positive data readouts from DAYLIGHT, BEACON and GLOW studies give the company three successful phase III pivotal studies with the candidate across three different retinal vascular and exudative diseases, such as wet AMD, RVO and NPDR.
Based on feedback from the FDA, Kodiak Sciences believes that it requires one additional pivotal study to support a regulatory filing of tarcocimab for all three indications.
Building on the success of the GLOW1 study, KOD initiated the pivotal phase III GLOW2 study evaluating tarcocimab in diabetic retinopathy, which is actively enrolling patients, during the fourth quarter of 2023. Kodiak Sciences recently reported that it has dosed the first patients in the GLOW2 study. Enrollment in the study is expected to be completed by the end of 2024.
The success of the GLOW2 study is expected to serve as the basis for a single biologics license application submission for tarcocimab, seeking its approval.
This positive development brought back the late-stage candidate in Kodiak Sciences’ pipeline, the development program for which, was abandoned earlier in 2023 after facing a major setback. The comeback of the tarcocimab problem has also reinstilled faith in the stakeholders of the company regarding the potential of the candidate in treating retinal diseases.
Year to date, shares of KOD have plunged 14.1% compared with the industry’s 7.9% decline.
Image Source: Zacks Investment Research
The company’s second clinical candidate, KSI-501, a dual inhibitor Trap-Antibody-Fusion bioconjugate molecule, is designed to target concurrent inflammation and abnormal angiogenesis observed in the pathogenesis of retinal vascular diseases.
Based on the success of the phase I study, KOD is currently planning to advance KSI-501 into a phase III study — DAYBREAK — to evaluate its efficacy, durability and safety in wet AMD. The company also plans to study tarcocimab as a second investigational arm in the DAYBREAK study in wet AMD, with KSI-501 being the first investigational arm. Pending discussion with the FDA, the company plans to initiate the DAYBREAK study as soon as regulatory alignment is completed.
The initiation of a second phase III study will give Kodiak Sciences two late-stage candidates, which is expected to provide some security to the company in terms of a fallback option in case one of the programs faces a setback.
Kodiak Sciences also expects to develop the unconjugated protein portion of KSI-501, KSI-101 (formerly known as KSI-501P), for patients who have retinal fluid and inflammation. It is a novel, potent and high-strength bispecific protein targeting IL-6 and VEGF. At present, there are no available intravitreal biologic therapies addressing the spectrum of inflammatory conditions of the retina, which represents a huge new market opportunity separate from the established anti-VEGF market.
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.
Kodiak Sciences anticipates beginning enrolment in the APEX study by the end of this month to evaluate the safety and tolerability and identify two dose levels of KSI-101 to progress into late-stage development. The pivotal phase IIb/III studies are expected to be initiated later in 2024.
The company also enjoys a comfortable cash position. It had cash, cash equivalents and marketable securities worth $245.9 million as of March-end, which Kodiak Sciences believes is enough to support its present and planned operations into 2026.
However, we cannot overlook the fact that clinical studies involve a high degree of risk and are prone to setbacks. The developmental timeline of tarcocimab has already been delayed significantly. Moreover, KOD’s portfolio is devoid of collaboration contracts for product development/commercialization, which is a concern.
Despite the drawbacks, the above-discussed factors indicate that Kodiak Sciences is a good stock to hold on to. In fact, any dip in stock price can be used as an opportunity to buy the stock. This could drive significant growth for investors’ portfolios as the company’s tarcocimab program has the potential for success based on the positive data readouts from the three prior pivotal studies. If approved, the company will have the first product in its commercial portfolio and start generating revenues. The clinical development programs of Kodiak Sciences’ other pipeline candidates are also progressing well which ensures that the company does not put all its eggs in one basket.
In the past 30 days, the Zacks Consensus Estimate for ALX Oncology’s 2024 loss per share has remained constant at $2.89. During the same period, the consensus estimate for 2025 loss per share has remained constant at $2.73. Year to date, shares of ALXO have plunged 53.5%.
ALX Oncology beat estimates in two of the trailing four quarters and missed twice, delivering an average negative surprise of 8.83%.
In the past 30 days, the Zacks Consensus Estimate for Annovis’ 2024 loss per share has remained constant at $2.46. During the same period, the consensus estimate for 2025 loss per share has remained constant at $1.95. Year to date, shares of ANVS have plunged 71.6%.
ANVS beat estimates in three of the trailing four quarters and missed once, delivering an average negative surprise of 1.39%.
In the past 30 days, the Zacks Consensus Estimate for Compugen’s 2024 earnings per share has increased from 2 cents to 5 cents. The consensus estimate for 2025 loss per share is currently pegged at 11 cents. Year to date, shares of CGEN have lost 6.1%.
CGEN’s earnings beat estimates in three of the trailing four quarters and missed once, delivering an average surprise of 5.79%.
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Should You Hold Kodiak Sciences (KOD) Stock in Your Portfolio?
Kodiak Sciences (KOD - Free Report) , a clinical-stage company, is focused on developing novel therapeutics to treat chronic, high-prevalence retinal diseases, which are the major causes of blindness. The company’s proprietary antibody biopolymer conjugate (ABC) platform is designed to maintain potent and effective drug levels in ocular tissues longer than the currently marketed biologic medicines for treating retinal diseases.
Toward the end of last year, Kodiak Sciences decided to reboot the development program of its lead candidate, tarcocimab (a novel anti-VEGF ABC), after witnessing positive top-line results from its phase III GLOW study evaluating the same in moderately severe to severe non-proliferative diabetic retinopathy (NPDR).
The company had previously reported the success of its phase III DAYLIGHT and BEACON studies evaluating tarcocimab in patients with wet AMD and retinal vein occlusion (RVO), respectively.The positive data readouts from DAYLIGHT, BEACON and GLOW studies give the company three successful phase III pivotal studies with the candidate across three different retinal vascular and exudative diseases, such as wet AMD, RVO and NPDR.
Based on feedback from the FDA, Kodiak Sciences believes that it requires one additional pivotal study to support a regulatory filing of tarcocimab for all three indications.
Building on the success of the GLOW1 study, KOD initiated the pivotal phase III GLOW2 study evaluating tarcocimab in diabetic retinopathy, which is actively enrolling patients, during the fourth quarter of 2023. Kodiak Sciences recently reported that it has dosed the first patients in the GLOW2 study. Enrollment in the study is expected to be completed by the end of 2024.
The success of the GLOW2 study is expected to serve as the basis for a single biologics license application submission for tarcocimab, seeking its approval.
This positive development brought back the late-stage candidate in Kodiak Sciences’ pipeline, the development program for which, was abandoned earlier in 2023 after facing a major setback. The comeback of the tarcocimab problem has also reinstilled faith in the stakeholders of the company regarding the potential of the candidate in treating retinal diseases.
Year to date, shares of KOD have plunged 14.1% compared with the industry’s 7.9% decline.
Image Source: Zacks Investment Research
The company’s second clinical candidate, KSI-501, a dual inhibitor Trap-Antibody-Fusion bioconjugate molecule, is designed to target concurrent inflammation and abnormal angiogenesis observed in the pathogenesis of retinal vascular diseases.
Based on the success of the phase I study, KOD is currently planning to advance KSI-501 into a phase III study — DAYBREAK — to evaluate its efficacy, durability and safety in wet AMD. The company also plans to study tarcocimab as a second investigational arm in the DAYBREAK study in wet AMD, with KSI-501 being the first investigational arm. Pending discussion with the FDA, the company plans to initiate the DAYBREAK study as soon as regulatory alignment is completed.
The initiation of a second phase III study will give Kodiak Sciences two late-stage candidates, which is expected to provide some security to the company in terms of a fallback option in case one of the programs faces a setback.
Kodiak Sciences also expects to develop the unconjugated protein portion of KSI-501, KSI-101 (formerly known as KSI-501P), for patients who have retinal fluid and inflammation. It is a novel, potent and high-strength bispecific protein targeting IL-6 and VEGF. At present, there are no available intravitreal biologic therapies addressing the spectrum of inflammatory conditions of the retina, which represents a huge new market opportunity separate from the established anti-VEGF market.
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.
Kodiak Sciences anticipates beginning enrolment in the APEX study by the end of this month to evaluate the safety and tolerability and identify two dose levels of KSI-101 to progress into late-stage development. The pivotal phase IIb/III studies are expected to be initiated later in 2024.
The company also enjoys a comfortable cash position. It had cash, cash equivalents and marketable securities worth $245.9 million as of March-end, which Kodiak Sciences believes is enough to support its present and planned operations into 2026.
However, we cannot overlook the fact that clinical studies involve a high degree of risk and are prone to setbacks. The developmental timeline of tarcocimab has already been delayed significantly. Moreover, KOD’s portfolio is devoid of collaboration contracts for product development/commercialization, which is a concern.
Despite the drawbacks, the above-discussed factors indicate that Kodiak Sciences is a good stock to hold on to. In fact, any dip in stock price can be used as an opportunity to buy the stock. This could drive significant growth for investors’ portfolios as the company’s tarcocimab program has the potential for success based on the positive data readouts from the three prior pivotal studies. If approved, the company will have the first product in its commercial portfolio and start generating revenues. The clinical development programs of Kodiak Sciences’ other pipeline candidates are also progressing well which ensures that the company does not put all its eggs in one basket.
Kodiak Sciences Inc. Price and Consensus
Kodiak Sciences Inc. price-consensus-chart | Kodiak Sciences Inc. Quote
Zacks Rank and Stocks to Consider
Kodiak Sciences currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks from the drug/biotech industry are ALX Oncology Holdings (ALXO - Free Report) , Annovis Bio (ANVS - Free Report) and Compugen (CGEN - Free Report) , each carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
In the past 30 days, the Zacks Consensus Estimate for ALX Oncology’s 2024 loss per share has remained constant at $2.89. During the same period, the consensus estimate for 2025 loss per share has remained constant at $2.73. Year to date, shares of ALXO have plunged 53.5%.
ALX Oncology beat estimates in two of the trailing four quarters and missed twice, delivering an average negative surprise of 8.83%.
In the past 30 days, the Zacks Consensus Estimate for Annovis’ 2024 loss per share has remained constant at $2.46. During the same period, the consensus estimate for 2025 loss per share has remained constant at $1.95. Year to date, shares of ANVS have plunged 71.6%.
ANVS beat estimates in three of the trailing four quarters and missed once, delivering an average negative surprise of 1.39%.
In the past 30 days, the Zacks Consensus Estimate for Compugen’s 2024 earnings per share has increased from 2 cents to 5 cents. The consensus estimate for 2025 loss per share is currently pegged at 11 cents. Year to date, shares of CGEN have lost 6.1%.
CGEN’s earnings beat estimates in three of the trailing four quarters and missed once, delivering an average surprise of 5.79%.