Tag: Cadrenal Therapeutics

Cadrenal Therapeutics (CVKD) – FY2023 Reported With Continued Progress Toward The Phase 3 Tecarfarin Trial

Posted on by cpereira@noblefcm.com


Wednesday, March 13, 2024

Robert LeBoyer, Senior Vice President, Equity Research Analyst, Biotechnology, Noble Capital Markets, Inc.

Refer to the full report for the price target, fundamental analysis, and rating.

Cadrenal Therapeutics Reported FYQ2023. Cadrenal announced a loss of $8.4 million or $(0.62) per share for FY2023 and $1.1 million or $(0.07) per share for 4Q23. The full-year loss consisted of Research and Development expense of $4.1 and General and Administrative Expense of $3.6 million, close to our estimates. Cash on December 31 was $8.5 million.

Tecarfarin IND Is Expected During 1H24. Cadrenal continues to work toward finalizing the trial protocols for the tecarfarin Phase 3 study, its oral anticoagulant for prevention of systemic thromboembolism in end-stage kidney disease (ESKD) patients with atrial fibrillation (irregular heartbeat, AFib). This is an Orphan population that can not use the commonly prescribed direct oral anticoagulants (DOAC) drugs.


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This Company Sponsored Research is provided by Noble Capital Markets, Inc., a FINRA and S.E.C. registered broker-dealer (B/D).

*Analyst certification and important disclosures included in the full report. NOTE: investment decisions should not be based upon the content of this research summary. Proper due diligence is required before making any investment decision. 

Release – Cadrenal Therapeutics Provides Fourth Quarter 2023 Corporate Update

Posted on by aweinsoff@channelchek.com

Research News and Market Data on CVKD

PONTE VEDRA, Fla., March 11, 2024 — 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 rare cardiovascular conditions, today provided a corporate update in connection with the filing of its Annual Report on Form 10-K for the year ended December 31, 2023.

Recent Highlights

  • Expanded focus for tecarfarin development beyond end-stage kidney disease (ESKD) with atrial fibrillation (AFib), to include patients with implanted medical devices such as left ventricular assist devices (LVADs) for heart failure as well as for the treatment of patients with antiphospholipid syndrome (APS) who require chronic anticoagulation. These two new potential rare medical conditions increase the total addressable market for tecarfarin in excess of $2 billion in the U.S. annually.
  • Engaged The Sage Group to assist the company in exploring strategic partnerships, co-development, and licensing agreements for tecarfarin.
  • Appointed Jeff Cole to the newly created position of Chief Operating Officer, responsible for the Company’s manufacturing and supply chain operations, intellectual property, commercialization strategies, and supporting partnering activities for tecarfarin.
  • Engaged pharmaceutical contract development and manufacturing organizations (CDMOs) to supply active pharmaceutical ingredients (API) and clinical trial materials.
  • Highlighted recent peer-reviewed article in the Journal of the American College of Cardiology (JACC) titled, “When Direct Oral Anticoagulants Should Not Be Standard Treatment” by Antoine Bejjani, MD, et.al examined the numerous medical conditions where direct oral anticoagulants (DOACs), such as Eliquis, Xarelto, Pradaxa, and Savaysa, should not be prescribed.
    • The article is consistent with the evolving evidence documenting the need for improved VKA-based anticoagulant therapy. Tecarfarin is the only new molecular entity (NME) that has been developed specifically to address this need.
  • Q4 2023 operating expenses (excluding non-cash items) totaled $1,160,000.
  • Cash used in operating activities totaled $694,000 during Q4 2023.
  • As of December 31, 2023, cash balances were $8.5 million.

Recent Reports and Presentations

  • Noble Capital Markets initiated equity research coverage on the Company with an “Outperform” rating and a price target of US$4.00 per share. The full report by Noble Capital Markets Senior Life Sciences Analyst Robert LeBoyer can be obtained from https://www.channelchek.com/research-reports/26351.
  • Douglas Losordo, M.D., Chief Medical Officer of Cadrenal, participated in a fireside chat moderated by Joe Pantginis, Ph.D., Managing Director of Research at H.C. Wainwright & Co., at the Lytham Partners 2024 Investor Select Conference. The webcast can be accessed HERE.
  • Company presented at Biotech Showcase™ 2024, alongside the J.P. Morgan 42nd Annual Healthcare Conference.
  • Participated in the Technology and Heart Failure Therapeutics Conference (THT 2024), which is produced by the Cardiovascular Research Foundation (CRF).
  • Filed updated corporate slide presentation in January 2024 highlighting the opportunity for tecarfarin.

Quang Pham, Founder, Chairman and Chief Executive Officer of Cadrenal Therapeutics, commented, “We believe there is a significant unmet need and market opportunity for tecarfarin in patients with rare cardiovascular conditions requiring chronic anticoagulation. Specifically, there is a lack of approved anticoagulation therapies for patients with left ventricular assist devices (LVADs), patients with end-stage kidney disease (ESKD) and atrial fibrillation (AFib), and patients with thrombotic anti-phospholipid syndrome (APS).”

“During the past year, an increasing number of industry articles and presentations have concurred with our positioning, which we believe enhances our opportunity from both a regulatory and commercial perspective. We have enhanced our intellectual property protection through the application and receipt of orphan drug designations, which provides for 7 years of market exclusivity, engaged industry leaders to explore strategic partnerships, co-development and licensing agreements for tecarfarin, and have expanded our manufacturing and supply chain capabilities in preparation of an expected pivotal trial. These activities pave the way for what we believe will be an exciting year for Cadrenal.”

ABOUT CADRENAL THERAPEUTICS, INC.

Cadrenal Therapeutics is developing tecarfarin for unmet needs in anticoagulation therapy. Tecarfarin is a late-stage novel oral and reversible anticoagulant (blood thinner) to prevent heart attacks, strokes, and deaths due to blood clots in patients with rare cardiovascular conditions. Tecarfarin has orphan drug and fast track designations from the FDA for the prevention of systemic thromboembolism (blood clots) of cardiac origin in patients with end-stage kidney disease (ESKD) and atrial fibrillation (AFib). Cadrenal is also pursuing additional regulatory strategies for unmet needs in anticoagulation therapy for patients with left ventricular assist devices (LVADs) and those with thrombotic antiphospholipid syndrome (APS). Tecarfarin is specifically designed to leverage a different metabolism pathway than the oldest and most commonly prescribed Vitamin K Antagonist (warfarin). Tecarfarin has been evaluated in eleven (11) human clinical trials and more than 1,000 individuals. In Phase 1, Phase 2, and Phase 2/3 clinical trials, tecarfarin has generally been well-tolerated in both healthy adult subjects and patients with chronic kidney disease. For more information, please visit: www.cadrenal.com.

Safe Harbor Statement

Any statements contained in this press release about future expectations, plans, and prospects, as well as any other statements regarding matters that are not historical facts, may constitute “forward-looking statements.” These statements include statements regarding the two new potential rare medical conditions increasing the total addressable market for tecarfarin to in excess of $2 billion in the U.S. annually, exploring strategic partnerships, co-development, and licensing agreements for tecarfarin, there being a significant unmet need and market opportunity for tecarfarin in patients with rare cardiovascular conditions requiring chronic anticoagulation, the increasing number of industry articles and presentations having concurred with the Company’s positioning, enhancing the Company’s opportunity from both a regulatory and commercial perspective, engaging industry leaders to explore strategic partnerships, co-development and licensing agreements for tecarfarin, 2024 being an exciting year . The words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” “would” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, the ability to enter into strategic partnerships, the ability to treat patients with rare cardiovascular conditions requiring chronic anticoagulation with tecarfarin, the ability to enhance the Company’s opportunity from both a regulatory and commercial perspective and the other risk factors described in the Company’s Annual Report on Form 10-K for the year ended December 31, 2023, and the Company’s subsequent filings with the SEC, including subsequent periodic reports on Quarterly Reports on Form 10-Q and Current Reports on Form 8-K. Any forward-looking statements contained in this press release speak only as of the date hereof and, except as required by federal securities laws, the Company specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events, or otherwise.

For more information, please contact:

Cadrenal Therapeutics:
Matthew Szot, CFO
858-337-0766
press@cadrenal.com

Investors:
Lytham Partners, LLC
Robert Blum, Managing Partner
602-889-9700
CVKD@lythampartners.com

View original content to download multimedia:https://www.prnewswire.com/news-releases/cadrenal-therapeutics-provides-fourth-quarter-2023-corporate-update-302084864.html

SOURCE

Release – Cadrenal Therapeutics Appoints Jeff Cole as Chief Operating Officer In Advance Of Tecarfarin Phase 3 Pivotal Trial

Posted on by aweinsoff@channelchek.com

Research News and Market Data on CVKD

PONTE VEDRA, Fla., Feb. 8, 2024 — Cadrenal Therapeutics, Inc. (Nasdaq: CVKD), a biopharmaceutical company developing tecarfarin, a novel Vitamin K Antagonist (VKA) for unmet needs in anticoagulation (blood thinning) therapy, today announced the appointment of Jeff Cole to the newly created position of Chief Operating Officer. In this role, Mr. Cole will be responsible for the Company’s manufacturing and supply chain operations, intellectual property, commercialization strategies, and supporting partnering activities for tecarfarin.

Mr. Cole brings over 25 years of experience in global pharmaceutical manufacturing and commercial operations, finance, and corporate development to the Company. This includes senior executive roles at both private and publicly-traded companies such as Espero BioPharma, Valeant Pharmaceuticals International (now Bausch Health Companies), and Legacy Pharmaceuticals. Mr. Cole co-founded Espero, a biopharmaceutical company focusing on the late-stage development and commercialization of medicines to treat cardiovascular diseases, and served as Board Director, President, and Chief Financial Officer where he was responsible for the company’s supply chain, commercialization, and multiple licensing and M&A transactions.

“Jeff is an extremely accomplished pharmaceutical operations executive with a deep understanding of product development, manufacturing, and commercialization. His experience will serve Cadrenal well as we advance our tecarfarin clinical program and evaluate partnering opportunities,” commented Quang Pham, Founder, Chairman and Chief Executive Officer of Cadrenal Therapeutics.

While at Valeant, Mr. Cole held roles of increasing responsibility, including as General Manager, Vice President of Corporate Development, and Chief Financial Officer of North America, where revenue more than tripled during his tenure. As General Manager at Valeant, Mr. Cole managed a division of U.S. prescription and OTC products across multiple therapeutic areas with responsibility for product development, supply, and commercial operations. Prior to the pharmaceutical industry, Mr. Cole served as Principal in the Financial Management Consulting practice at PricewaterhouseCoopers.

“I am excited to be joining the team at Cadrenal at a pivotal time when demand is increasing for a new anticoagulation therapy to address the unmet needs for patients with left ventricular assist devices (LVADs), antiphospholipid syndrome (APS), and those with end-stage kidney disease (ESKD) and atrial fibrillation (AFib),” added Jeff Cole. “I look forward to leveraging my experience to advance tecarfarin to the market and help those underserved patient groups.”

Mr. Cole holds an MBA with honors from the University of Michigan and a BS in accounting from the University of Southern California.

ABOUT CADRENAL THERAPEUTICS, INC.

Cadrenal Therapeutics is developing tecarfarin for unmet needs in anticoagulation therapy. Tecarfarin is 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 medical conditions. Tecarfarin has orphan drug and fast track designations from the FDA for the prevention of systemic thromboembolism (blood clots) of cardiac origin in patients with end-stage kidney disease (ESKD) and atrial fibrillation (AFib). Cadrenal is also pursuing additional regulatory strategies for unmet needs in anticoagulation therapy for patients with left ventricular assist devices (LVADs) and those with thrombotic antiphospholipid syndrome (APS). Tecarfarin is specifically designed to leverage a different metabolism pathway than the oldest and most commonly prescribed Vitamin K Antagonist (warfarin). Tecarfarin has been evaluated in eleven (11) human clinical trials and more than 1,000 individuals. In Phase 1, Phase 2, and Phase 2/3 clinical trials, tecarfarin has generally been well-tolerated in both healthy adult subjects and patients with chronic kidney disease. For more information, please visit: www.cadrenal.com.

Safe Harbor Statement

Any statements contained in this press release about future expectations, plans, and prospects, as well as any other statements regarding matters that are not historical facts, may constitute “forward-looking statements.” These statements include statements regarding the Mr. Cole’s experience serving the Company well as it advances its tecarfarin clinical program and evaluates partnering opportunities and leveraging Mr. Cole’s experience to advance tecarfarin to the market and help underserved patient groups. The words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” “would” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including the expected contribution from Mr. Cole and the ability to advance tecarfarin with patients with left ventricular assist devices (LVADs), thrombotic APS, and those with AFib and ESKD and the other risk factors described in the Company’s Annual Report on Form 10-K for the year ended December 31, 2022, and the Company’s subsequent filings with the SEC, including subsequent periodic reports on Quarterly Reports on Form 10-Q and Current Reports on Form 8-K. Any forward-looking statements contained in this press release speak only as of the date hereof and, except as required by federal securities laws, the Company specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events, or otherwise.

For more information, please contact:

Cadrenal Therapeutics:
Matthew Szot, CFO
858-337-0766
press@cadrenal.com

Investors:
Lytham Partners, LLC
Robert Blum, Managing Partner
602-889-9700
CVKD@lythampartners.com

View original content to download multimedia:https://www.prnewswire.com/news-releases/cadrenal-therapeutics-appoints-jeff-cole-as-chief-operating-officer-in-advance-of-tecarfarin-phase-3-pivotal-trial-302057004.html

SOURCE Cadrenal Therapeutics, Inc.

Cadrenal Therapeutics (CVKD) – Peer-Reviewed Journal Reviews Uses of DOAC Drugs, Pointing To The Need For Tecarfarin

Posted on by cpereira@noblefcm.com


Thursday, February 01, 2024

Robert LeBoyer, Senior Vice President, Equity Research Analyst, Biotechnology, Noble Capital Markets, Inc.

Refer to the full report for the price target, fundamental analysis, and rating.

New Article Discusses Uses and Contraindicated Patient Groups. An article in the Journal of the American College of Cardiology titled “When Direct Oral Anticoagulants Should Not Be Standard Treatment: JACC State-of-the-Art Review” summarized indications where DOAC drugs are commonly used, indications where they should not be used, and indications where efficacy is uncertain. The paper identifies conditions that tecarfarin is being developed to treat and supports the need we see for the drug.

DOAC Drugs Are Not For All Patients. The Direct Oral Anticoagulants (DOAC) drugs are anticoagulants that act on one specific protein in the clotting cascade. The class includes Eliquis (apixaban), Xarelto (rivaroxaban), Savaysa (edoxaban), and Pradaxa (dabigatran). Although these are effective in many conditions, some clinical trials have shown adverse findings and conditions where they should not be used.


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Equity Research is available at no cost to Registered users of Channelchek. Not a Member? Click ‘Join’ to join the Channelchek Community. There is no cost to register, and we never collect credit card information.

This Company Sponsored Research is provided by Noble Capital Markets, Inc., a FINRA and S.E.C. registered broker-dealer (B/D).

*Analyst certification and important disclosures included in the full report. NOTE: investment decisions should not be based upon the content of this research summary. Proper due diligence is required before making any investment decision. 

Release – Cadrenal Therapeutics Highlights Publication of Peer-Reviewed Article Supporting Need for New Anticoagulation Therapy for Patients with Certain Medical Conditions

Posted on by aweinsoff@channelchek.com

Research News and Market Data on CVKD

31 Jan, 2024, 09:00 ET

PONTE VEDRA, Fla., Jan. 31, 2024 /PRNewswire/ — Cadrenal Therapeutics, Inc., (Nasdaq: CVKD), a biopharmaceutical company developing tecarfarin, a novel Vitamin K Antagonist (VKA) for unmet needs in anticoagulation (blood thinning) therapy, cited today a recent peer-reviewed article in the Journal of the American College of Cardiology (JACC) titled, “When Direct Oral Anticoagulants Should Not Be Standard Treatment” by Antoine Bejjani, MD, et.al. The article examines the numerous medical conditions where direct oral anticoagulants (DOACs), such as Eliquis, Xarelto, Pradaxa, and Savaysa, should not be prescribed.

Consistent with the evolving evidence documenting the need for VKA-based anticoagulant therapy, while simultaneously recognizing the deficiencies of the available VKA anticoagulants (such as warfarin), this latest peer-reviewed journal publication highlights:

  • For most patients, DOACs are preferred over existing Vitamin K Antagonists [warfarin] for stroke prevention in atrial fibrillation (AFib) and venous thromboembolism treatment.
  • However, randomized controlled trials indicate that DOACs may not be as efficacious or as safe in conditions such as mechanical heart valves, thrombotic antiphospholipid syndrome (APS), and AFib associated with end-stage kidney disease (ESKD).
  • Their [DOACs] efficacy is uncertain for conditions such as left ventricular thrombus, and for patients with AFib or venous thrombosis who have ESKD.

“This expert review provides an assessment of the available evidence regarding DOACs, detailing not only when they have demonstrated efficacy and safety, but also when the DOACs have failed and therefore should not be the standard of care,” commented Quang Pham, Founder, Chairman and Chief Executive Officer of Cadrenal Therapeutics. “These critical gaps in anticoagulation therapy, such as for patients with left ventricular assist devices (LVADs), thrombotic APS, and those with AFib and ESKD, highlight and support the need for the advancement of our tecarfarin development program to serve these patients.”

Further information on the article is available at https://www.jacc.org/doi/epdf/10.1016/j.jacc.2023.10.038.

ABOUT CADRENAL THERAPEUTICS, INC.
Cadrenal Therapeutics is developing tecarfarin for unmet needs in anticoagulation therapy. Tecarfarin is 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 medical conditions. Tecarfarin has orphan drug and fast track designations from the FDA for the prevention of systemic thromboembolism (blood clots) of cardiac origin in patients with end-stage kidney disease (ESKD) and atrial fibrillation (AFib). Cadrenal is also pursuing additional regulatory strategies for unmet needs in anticoagulation therapy for patients with left ventricular assist devices (LVADs) and those with thrombotic antiphospholipid syndrome (APS). Tecarfarin is specifically designed to leverage a different metabolism pathway than the oldest and most commonly prescribed Vitamin K Antagonist (warfarin). Tecarfarin has been evaluated in eleven (11) human clinical trials and more than 1,000 individuals. In Phase 1, Phase 2, and Phase 2/3 clinical trials, tecarfarin has generally been well-tolerated in both healthy adult subjects and patients with chronic kidney disease. For more information, please visit: www.cadrenal.com.  

Safe Harbor Statement

Any statements contained in this press release about future expectations, plans, and prospects, as well as any other statements regarding matters that are not historical facts, may constitute “forward-looking statements.” These statements include statements regarding the critical gaps in anticoagulation therapy, such as for patients with left ventricular assist devices (LVADs), thrombotic APS, and those with AFib and ESKD, highlighting and supporting the need for the advancement of our tecarfarin development program to serve these patients.The words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” “would” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including the ability to advance tecarfarin with patients with left ventricular assist devices (LVADs), thrombotic APS, and those with AFib and ESKD and the other risk factors described in the Company’s Annual Report on Form 10-K for the year ended December 31, 2022, and the Company’s subsequent filings with the SEC, including subsequent periodic reports on Quarterly Reports on Form 10-Q and Current Reports on Form 8-K. Any forward-looking statements contained in this press release speak only as of the date hereof and, except as required by federal securities laws, the Company specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events, or otherwise.

For more information, please contact:

Cadrenal Therapeutics:
Matthew Szot, CFO
858-337-0766
press@cadrenal.com 

Investors:
Lytham Partners, LLC
Robert Blum, Managing Partner
602-889-9700
CVKD@lythampartners.com 

SOURCE

Cadrenal Therapeutics (CVKD) – Addressing Unmet Anticoagulation Needs In Orphan Populations

Posted on by cpereira@noblefcm.com


Monday, December 18, 2023

Robert LeBoyer, Senior Vice President, Equity Research Analyst, Biotechnology, Noble Capital Markets, Inc.

Refer to the full report for the price target, fundamental analysis, and rating.

Initiating Coverage Of CVKD.  Cadrenal Therapeutics is developing tecarfarin, an oral anticoagulant for prevention of systemic thromboembolism (blood clots) in rare medical conditions where patients cannot take the commonly prescribed oral anticoagulants. The only available therapy is warfarin, a drug with wide variations in bloodstream levels that requires frequent monitoring to prevent side effects including excessive bleeding risk.

Phase 3 Trial Is Expected In 2024. The lead orphan indication for tecarfarin is in patients with end-stage kidney disease (ESKD) with atrial fibrillation (AFib, irregular heartbeat). The ACTOR-AF Phase 3 trial has been designed as a randomized, double-blind, placebo-controlled study testing tecarfarin against placebo. The amended protocol is expected to be submitted in 1H24 to allow patient treatment to begin in 2H24.


Get the Full Report

Equity Research is available at no cost to Registered users of Channelchek. Not a Member? Click ‘Join’ to join the Channelchek Community. There is no cost to register, and we never collect credit card information.

This Company Sponsored Research is provided by Noble Capital Markets, Inc., a FINRA and S.E.C. registered broker-dealer (B/D).

*Analyst certification and important disclosures included in the full report. NOTE: investment decisions should not be based upon the content of this research summary. Proper due diligence is required before making any investment decision.