On this page of StockholderLetter.com we present the latest annual shareholder letter from Cadrenal Therapeutics, Inc. — ticker symbol CVKD. Reading current and past CVKD letters to shareholders can bring important insights into the investment thesis.
NA SDAQ: CVKD

ANNUAL
REPORT
DEAR SHAREHOLDERS
In 2023, Cadrenal embarked on our exciting journey as a publicly traded company. We set our unwavering mission: bring to market
our next-generation Vitamin K Antagonist (VKA), tecarfarin, for patients in need. Tecarfarin is our late-stage novel oral and
reversible anticoagulant (more commonly referred to as a blood thinner) to prevent heart attacks, strokes, and deaths due to blood
clots in patients with rare cardiovascular conditions who require lifelong anticoagulation.
While the anticoagulant market is extremely large, our focus is to develop tecarfarin as a therapy for patients with certain unmet
needs where the only drug used, warfarin, has failed to achieve reliable results, and the newer class of medications commonly
called DOACs (Eliquis, Xarelto, Pradaxa, and Savaysa) have not shown clinical benefit. This unmet sector of the anticoagulant
market presents a significant commercial opportunity that is estimated to be at $2 billion per year.
Specifically, we have identified three areas where we believe tecarfarin can be the lead therapy for patients requiring lifelong
anticoagulation. These include patients with:
Implanted mechanical circulatory support devices, which include the left ventricular assist device (LVAD);
End-stage kidney disease (ESKD) with Atrial Fibrillation (AFib); and
Thrombotic Antiphospholipid Syndrome (APS).
We have received orphan drug designation from the U.S. Food and Drug Administration (FDA) for the first two indications
mentioned above (LVADs and ESKD + AFib), and have submitted our orphan drug application to the FDA for APS. These are critical
designations as they provide potential seven-year marketing exclusivities after approval, and clarity regarding the pathway to
approval. We also received a Fast Track designation for ESKD + AFib.
During the past year, an increasing number of scientific articles and medical meeting presentations underscore the deficiencies
of warfarin and the need for a new VKA therapy for patients with rare cardiovascular conditions. For example, in April 2024, a
groundbreaking presentation was made discussing an analysis of the Abbott-sponsored ARIES-HM3 trial data. One key point from
the data was the importance of LVAD patients maintaining targeted time in therapeutic range (TTR), a quality measure for VKAs.
Dr. Mandeep Mehra, who chaired the ARIES-HM3 study, holds the William Harvey Distinguished Chair in Advanced Cardiovascular
Medicine and is Executive Director of the Center for Advanced Heart Disease at Brigham and Women   s Hospital, recently
commented,       Tecarfarin could potentially be an important therapy for patients with LVADs who all require chronic
anticoagulation since it does not get affected by drug-drug interactions or changes in kidney function like warfarin and deserves
further study." We believe our VKA tecarfarin, with its unique retrometabolic design that provides for more stable anticoagulation
than warfarin, is the much-needed replacement therapy for this patient population.
As we look to the rest of 2024 and beyond, we intend to pursue a pivotal trial to evaluate tecarfarin   s effectiveness for LVAD
patients. To prepare for this trial, we are simultaneously advancing our pharmaceutical contract development and manufacturing
organizations to supply active pharmaceutical ingredients, drug products, and clinical trial materials while exploring strategic
partnerships, co-development, and licensing agreements for tecarfarin to help us accelerate clinical development.
While we are proud of our progress, the Cadrenal team is working hard to advance these critical clinical imperatives and continue to
build value for our shareholders. Thank you for your continued patience and support of Cadrenal. We are excited about our future as
we look to bring a much-needed blood thinner solution to these underserved patients.
Respectfully,
 1 *#  h  $ )

Chairman & Chief Executive Officer
 • shareholder letter icon 6/11/2024 Letter Continued (Full PDF)
 • stockholder letter icon 8/28/2023 CVKD Stockholder Letter
 • stockholder letter icon More "Biotechnology" Category Stockholder Letters
 • Benford's Law Stocks icon CVKD Benford's Law Stock Score = 52


CVKD Shareholder/Stockholder Letter Transcript:

NA SDAQ: CVKD

ANNUAL
REPORT

DEAR SHAREHOLDERS
In 2023, Cadrenal embarked on our exciting journey as a publicly traded company. We set our unwavering mission: bring to market
our next-generation Vitamin K Antagonist (VKA), tecarfarin, for patients in need. Tecarfarin is our late-stage novel oral and
reversible anticoagulant (more commonly referred to as a blood thinner) to prevent heart attacks, strokes, and deaths due to blood
clots in patients with rare cardiovascular conditions who require lifelong anticoagulation.
While the anticoagulant market is extremely large, our focus is to develop tecarfarin as a therapy for patients with certain unmet
needs where the only drug used, warfarin, has failed to achieve reliable results, and the newer class of medications commonly
called DOACs (Eliquis, Xarelto, Pradaxa, and Savaysa) have not shown clinical benefit. This unmet sector of the anticoagulant
market presents a significant commercial opportunity that is estimated to be at $2 billion per year.
Specifically, we have identified three areas where we believe tecarfarin can be the lead therapy for patients requiring lifelong
anticoagulation. These include patients with:
Implanted mechanical circulatory support devices, which include the left ventricular assist device (LVAD);
End-stage kidney disease (ESKD) with Atrial Fibrillation (AFib); and
Thrombotic Antiphospholipid Syndrome (APS).
We have received orphan drug designation from the U.S. Food and Drug Administration (FDA) for the first two indications
mentioned above (LVADs and ESKD + AFib), and have submitted our orphan drug application to the FDA for APS. These are critical
designations as they provide potential seven-year marketing exclusivities after approval, and clarity regarding the pathway to
approval. We also received a Fast Track designation for ESKD + AFib.
During the past year, an increasing number of scientific articles and medical meeting presentations underscore the deficiencies
of warfarin and the need for a new VKA therapy for patients with rare cardiovascular conditions. For example, in April 2024, a
groundbreaking presentation was made discussing an analysis of the Abbott-sponsored ARIES-HM3 trial data. One key point from
the data was the importance of LVAD patients maintaining targeted time in therapeutic range (TTR), a quality measure for VKAs.
Dr. Mandeep Mehra, who chaired the ARIES-HM3 study, holds the William Harvey Distinguished Chair in Advanced Cardiovascular
Medicine and is Executive Director of the Center for Advanced Heart Disease at Brigham and Women   s Hospital, recently
commented,       Tecarfarin could potentially be an important therapy for patients with LVADs who all require chronic
anticoagulation since it does not get affected by drug-drug interactions or changes in kidney function like warfarin and deserves
further study." We believe our VKA tecarfarin, with its unique retrometabolic design that provides for more stable anticoagulation
than warfarin, is the much-needed replacement therapy for this patient population.
As we look to the rest of 2024 and beyond, we intend to pursue a pivotal trial to evaluate tecarfarin   s effectiveness for LVAD
patients. To prepare for this trial, we are simultaneously advancing our pharmaceutical contract development and manufacturing
organizations to supply active pharmaceutical ingredients, drug products, and clinical trial materials while exploring strategic
partnerships, co-development, and licensing agreements for tecarfarin to help us accelerate clinical development.
While we are proud of our progress, the Cadrenal team is working hard to advance these critical clinical imperatives and continue to
build value for our shareholders. Thank you for your continued patience and support of Cadrenal. We are excited about our future as
we look to bring a much-needed blood thinner solution to these underserved patients.
Respectfully,
 1 *#  h  $ )

Chairman & Chief Executive Officer



shareholder letter icon 6/11/2024 Letter Continued (Full PDF)
 

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