CVKD comes out stomping early and could start testing the $1.00 level early.

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Here We Go? Low Float (CVKD) Could Start Testing The $1.00 Level On Huge Breaking News

September 5th

Greetings Readers,

CVKD comes out stomping early and could start testing the $1.00 level early.

Part of today's green push could be attributed to the company's huge breaking news this morning.

Check it out:

Cadrenal Therapeutics Highlights Additional Need for a New Vitamin K Antagonist (Tecarfarin) Following Updates from the Recent European Society of Cardiology Congress

Tecarfarin is the only known Novel Vitamin K Antagonist in Development

PONTE VEDRA, Fla., Sept. 5, 2023 /PRNewswire/ -- Cadrenal Therapeutics, Inc., (Nasdaq: CVKD) a biopharmaceutical company developing tecarfarin, a late-stage novel oral and reversible anticoagulant (blood thinner) designed to prevent heart attacks, strokes and deaths due to blood clots in patients with certain rare medical conditions, today cited recent data that underscores additional need for an improved Vitamin K Antagonist (VKA). The Company believes tecarfarin is the solution for this unmet need.

At the recent European Society of Cardiology Congress (ESC) in Amsterdam, The Netherlands, the open-label "FRAIL-AF" trial was presented, revealing that switching International Normalized Ratio (INR)-guided VKA treatment to direct oral anticoagulants (DOACs aka NOACs) in frail older patients with Atrial Fibrillation (AFib) was associated with more bleeding complications compared to continuing VKA treatment, without an associated reduction in thromboembolic complications. Reports indicate that this unique trial was stopped early for futility in seeking superiority for the direct oral anticoagulant (DOAC) strategy. FRAIL-AF was deemed the most important study from ESC, according to Medscape.

In the report, study author Geert-Jan Geersing, MD, PhD, of the University Medical Center Utrecht in the Netherlands, at the ESC Congress concluded that "Switching from a VKA to a NOAC should not be considered without a clear indication in frail older patients with AFib."

Cadrenal is developing tecarfarin, a novel Vitamin K Antagonist, targeted for indications where existing VKAs fail to achieve sufficiently stable anticoagulation and DOACs (Eliquis-class drugs) are not widely prescribed.

"The findings of the FRAIL-AF study highlight the benefits of VKAs compared to DOACs in an additional unique patient population," commented Quang Pham, CEO of Cadrenal Therapeutics. "Tecarfarin, an enhanced VKA, avoids the existing metabolism problems of currently available VKAs by using an alternate metabolic pathway. We believe tecarfarin will provide improved outcomes for patients with certain rare medical conditions. Cadrenal has identified three such rare medical conditions: End-Stage Kidney Disease (ESKD) with Atrial Fibrillation (AFib); Left Ventricular Assist Devices (LVADs); and Antiphospholipid Syndrome (APS)."

Currently, tecarfarin has orphan drug and Fast Track designations for the prevention of systemic thromboembolism (blood clots) of cardiac origin in patients with ESKD and AFib, providing for 7-year marketing exclusivity.

Based on management's market analysis studies and expected adoption rates, these three rare medical conditions present a U.S. market opportunity in excess of $2Bn per year.

Read the full article here.

Remember, this is a low float profile which means volatility can take hold in a second.

With Yahoo Finance reporting a float of fewer than 5Mn shares and today's big news, CVKD needs to be on radar now.

Read my initial report below and get CVKD pulled up quickly.

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It's crystal clear why anyone should aggressively follow a biopharmaceutical company on the brink of releasing a groundbreaking anticoagulant.

Lives are at stake, and we're talking about preventing heart attacks, strokes, and deaths here!

For patients with rare medical conditions that make them prone to blood clots, this could be their lifeline.

The existing treatments are archaic, demanding constant monitoring, dietary restrictions, and they still come with significant risks.

Right now, one company's progress towards a better-functioning anticoagulant treatment could lead to a revolutionary shift in healthcare.

Imagine a world where these patients no longer have to endure the hardships of older anticoagulants, where they can have a safer, more convenient option right at their fingertips.

This is more than just a medical development; it's a beacon of hope for countless individuals living with the constant fear of life-threatening clots.

And let's not forget, pushing for such innovations can lead to reduced healthcare costs, improved patient well-being, and even economic growth.

That's why with a flagship therapy that's Phase 3-ready, a low float of fewer than 4Mn shares, huge August news regarding new addressable markets, a 2023 addition to the Nasdaq CM, and a 2023 Fast Track designation, this biopharma company could start gaining traction way ahead of 2024.

Drop everything and pull up this Nasdaq breakout idea:

*Cadrenal Therapeutics, Inc. (CVKD)*

Cadrenal Therapeutics is developing tecarfarin, a late-stage novel oral and reversible anticoagulant (blood thinner), to prevent heart attacks, strokes, and deaths due to blood clots in patients with certain rare medical conditions.

Tecarfarin has orphan drug and Fast Track designations for the prevention of systemic thromboembolism (blood clots) of cardiac origin in patients with end-stage renal disease, and atrial fibrillation.

And based on several potential breakout catalysts, CVKD needs to be on your radar this second. Check 'em out:

No. 1 - Volatility Could Be Significant Based On CVKD's Low Float Size

No. 2 - Huge August News Brings In New Addressable Market Potential

No. 3 - 2023's Bombshell News (U.S. FDA Grants Fast Track Designation To Tecarfarin)

No. 4 - Exposure Could Be Growing As CVKD Joins The Nasdaq CM In 2023

No. 5 - Company Strengthens Board With Industry Leader (Former CCO Of Arena Pharmaceuticals)

But more on those in a second...

CVKD's Focus: End-Stage Renal Disease and Atrial Fibrillation (ESRD + AFib)

Patients with end-stage renal disease and AFib represent a spectrum of disorders involving both the heart and kidneys (known as cardiorenal syndrome or CRS) in which acute or chronic dysfunction in one organ may induce acute or chronic dysfunction in the other organ.

The Problem

There are currently no effective treatment options for patients with end-stage renal disease and AFib.

Commonly prescribed treatments, such as warfarin and apixaban, may cause substantial harm, leading to outcomes such as stroke, systemic embolism, major bleeding, or death. Yet most trials of anticoagulant therapy to reduce the risk of such events have excluded these patients.

These patients have typically been excluded from randomized clinical trials because approved therapies for AFib have metabolic profiles that may increase drug exposures in patients thereby increasing known risks and challenges in managing patients with ESRD + AFib.

Prevalence

AFib is the most common arrhythmia, with its incidence and prevalence increasing over the last 20 years.

There are more than 809,000 Americans with ESRD, with approximately 70% on dialysis. Approximately 150,000 ESRD patients also have AFib.

AFib nearly doubles the anticipated mortality and increases the stroke risk by approximately five-fold in these patients.

CVKD's Solution

Their lead drug candidate, tecarfarin, targets a different metabolic pathway than the most commonly prescribed drugs for the treatment of thrombosis and AFib in order to potentially eliminate specific side effects while maintaining or improving effectiveness.

Tecarfarin has been evaluated in 11 human clinical trials in over a thousand individuals.

In Phase 1, Phase 2 and Phase 2/3 clinical trials that have been conducted thus far, tecarfarin has generally been well-tolerated in both healthy adult patients and patients with ESRD and chronic kidney disease.

Tecarfarin Looks to Solve Warfarin’s Major Problems

Tecarfarin potentially provides a more stable anticoagulation than warfarin due to its metabolism, thereby decreasing the risk of stroke and bleeding

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Tecarfarin Clinical Development Pipeline

Late-stage drug with orphan drug and Fast track designations

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Large Addressable Market Opportunities for Rare Medical Conditions*

U.S. market potential estimated in excess of $2Bn for three focused rare medical condition indications

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* Based on management’s market analysis studies and expected adoption rates.

Sources And More Key Details: Company Website. Company Presentation.

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As mentioned above, CVKD has several potential breakout catalysts to focus in on right now. Check them out:

No. 1 CVKD Potential Catalyst - Volatility Could Be Significant Based On CVKD's Low Float Size

According to the Yahoo Finance website, CVKD has a very low float.

The website reports this profile to have approximately 3.74Mn shares in its float.

Why is that important? It's important on one crucial level. Volatility.

Could positive company news before the end of this year help provide a near term spark?

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No. 2 CVKD Potential Catalyst - Huge August News Brings In New Addressable Market Potential

On two separate occasions this past month, CVKD announced different health issues that the company's flagship drug candidate, tecarfarin, could replace warfarin as the preferred treatment.

8/30/23 - Cadrenal Therapeutics Expands Evaluation of Tecarfarin for Patients with Antiphospholipid Syndrome (APS)

"Antiphospholipid syndrome is a rare medical condition and blood clotting disorder affecting approximately 167k patients in the United States which currently has no cure. Effective anticoagulation (with blood thinners) should prevent health problems caused by the condition with the goal of treatment to prevent blood clots from forming and to keep existing clots from getting larger," commented Douglas Losordo, Chief Medical Officer of Cadrenal Therapeutics. "However, the only widely prescribed anticoagulant approved for this patient population is warfarin, a 70-year-old drug, which fails to achieve sufficiently reliable anticoagulation due to the way in which it is metabolized. We believe tecarfarin, which is specifically designed to solve warfarin's metabolism problem by using an alternate pathway, could provide improved outcomes for this patient population. Tecarfarin's metabolic pathway is abundant and essentially insaturable, which results in a reliable, stable pharmacokinetic profile."

8/1/23 - Cadrenal Therapeutics Expands Focus for Tecarfarin to Patients with Implanted Medical Devices for Heart Diseases

"The goal for Cadrenal is to advance tecarfarin in targeted indications where Vitamin K antagonists (warfarin) are prescribed yet have failed to achieve sufficiently reliable anticoagulation," commented Quang Pham, CEO of Cadrenal Therapeutics. "Patients with implanted medical devices such as left ventricular assist devices (LVADs) struggle with warfarin due to the way in which it is metabolized, resulting in suboptimal anticoagulation. Tecarfarin is specifically designed to solve warfarin's metabolism problem via an alternate pathway that is abundant and essentially insaturable, providing a much more reliable pharmacokinetic profile. We look forward to expanding our focus for tecarfarin within this patient population."

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No. 3 CVKD Potential Catalyst - 2023's Bombshell News (U.S. FDA Grants Fast Track Designation To Tecarfarin)

Cadrenal Therapeutics (Nasdaq: CVKD) Granted FDA Fast Track Designation for Tecarfarin for Prevention of Systemic Thromboembolism of Cardiac Origin in Patients with End-Stage Renal Disease and Atrial Fibrillation

PONTE VEDRA, Fla., Jan. 23, 2023 /PRNewswire/ — Cadrenal Therapeutics (Nasdaq: CVKD), a biopharmaceutical company focused on developing tecarfarin, a clinical-stage novel cardiorenal therapy with orphan drug designation, announced today that the U.S. Food and Drug Administration (FDA) has granted a Fast Track designation to tecarfarin for the prevention of systemic thromboembolism, more commonly referred to as blood clots, of cardiac origin in patients with end-stage renal disease (ESRD) and atrial fibrillation (AFib).

...

"The Fast Track designation for tecarfarin is an important milestone in the development of this therapy and highlights the importance of finding an effective treatment for the prevention of blood clots of cardiac origin in patients with ESRD and AFib," said Quang Pham, Chief Executive Officer of Cadrenal. "We look forward to working closely with the FDA to evaluate this therapy as a potential new treatment option for this underserved patient population."

...

Read the full article here.

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No. 4 CVKD Potential Catalyst - Exposure Could Be Growing As CVKD Joins The Nasdaq CM In 2023

Cadrenal Therapeutics (Nasdaq: CVKD) Announces Closing of Initial Public Offering

PONTE VEDRA, Fla., Jan. 24, 2023 /PRNewswire/ — Cadrenal Therapeutics, Inc. (Nasdaq: CVKD), a biopharmaceutical company focused on developing tecarfarin, a clinical-stage novel cardiorenal therapy with orphan drug indication, today announced the closing of its initial public offering of 14Mn shares of common st-ock at a public offering price of $5.00 per share for gross proceeds of $7Mn, before deducting underwriting discounts and estimated offering expenses. ...

The Company's common st-ock began trading on the Nasdaq Capital Market on January 20, 2023, under the symbol "CVKD."

...

Read the full article here.

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No. 5 CVKD Potential Catalyst - Company Strengthens Board With Industry Leader (Former CCO Of Arena Pharmaceuticals)

Cadrenal Therapeutics Announces Appointment of Robert Lisicki to Board of Directors

PONTE VEDRA, Fla., July 24, 2023 /PRNewswire/ -- Cadrenal Therapeutics, Inc., ("Cadrenal" or the "Company") (Nasdaq: CVKD), a biopharmaceutical company developing tecarfarin, a late-stage novel oral and reversible anticoagulant (blood thinner) for certain rare medical conditions, today announced the appointment of Robert Lisicki to its Board of Directors and Compensation and Nomination/Governance Committees. Lisicki brings over 25 years of experience in the pharma/biotech sector, including as the Chief Commercial Officer of Arena Pharmaceuticals, where he provided global visionary leadership for the $6.7Bn growth-stage biopharmaceutical company through their acquisition by Pfizer in March 2022.

"Robert is a highly accomplished executive with a proven track record leading rapidly growing clinical-stage public companies, including successes with cardiovascular therapeutics and strong relationships with life sciences investors. His experience in developing collaborative research agreements with large pharma across multiple therapeutic areas will be a valuable asset as we look to advance tecarfarin," said Quang Pham, Chairman and CEO of Cadrenal. "I look forward to leaning on his executive experience and commercial vision as a member of the Cadrenal board."

During his time as Chief Commercial Officer at Arena Pharmaceuticals, Lisicki had a leadership role in more than $8Bn in M&A activities. He regularly interacted with FDA, EMA, and PDMA on study and protocol designs.

...

"I believe Cadrenal Therapeutics is developing a novel and potentially paradigm-changing therapeutic," said Robert Lisicki. "I look forward to working with the team to advance the development and value that Tecarfarin may bring to serious and life-threatening diseases."

Lisicki will occupy a newly created seat on the Cadrenal Board of Directors.

Read the full article here.

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CVKD Recap - 5 Must-See Potential Breakout Catalysts Right Now

No. 1 - Volatility Could Be Significant Based On CVKD's Low Float Size

No. 2 - Huge August News Brings In New Addressable Market Potential

No. 3 - 2023's Bombshell News (U.S. FDA Grants Fast Track Designation To Tecarfarin)

No. 4 - Exposure Could Be Growing As CVKD Joins The Nasdaq CM In 2023

No. 5 - Company Strengthens Board With Industry Leader (Former CCO Of Arena Pharmaceuticals)

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Coverage is officially initiated on CVKD. When time allows, do this:

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Hang tight. The full report arrives soon.

Sincerely,

Kai Parker

StockWireNews


(Always Remember The Stock Prices Could Be Significantly Lower Now From The Dates I Provided.)

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