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UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
WASHINGTON,
D.C. 20549
FORM
8-K
CURRENT
REPORT
Pursuant
to Section 13 or 15(d) of the Securities Exchange Act of 1934
Date
of Report (date of earliest event reported): March 11, 2024
Cadrenal Therapeutics, Inc.
(Exact
name of registrant as specified in charter)
Delaware |
|
001-41596 |
|
88-0860746 |
(State or other jurisdiction
of incorporation) |
|
(Commission File
Number) |
|
(IRS Employer
Identification No.) |
822 A1A North, Suite 306
Ponte Vedra, Florida 32082
(Address
of principal executive offices and zip code)
(904)
300-0701
(Registrant’s
telephone number including area code)
N/A
(Former
name or former address, if changed since last report)
Check
the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of registrant under any
of the following provisions (see General Instruction A.2. below):
☐ | Written
communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
☐ | Soliciting
material pursuant to Rule 14a-12(b) under the Exchange Act (17 CFR 240.14a-12) |
☐ | Pre-commencement
communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
☐ | Pre-commencement
communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Securities
registered pursuant to Section 12(b) of the Act:
Title
of each class |
|
Trading
Symbols |
|
Name
of each exchange on which registered |
Common Stock, par value $0.001 per share |
|
CVKD |
|
The
Nasdaq Stock Market LLC (Nasdaq Capital
Market) |
Indicate
by check mark whether the registrant is an emerging growth company as defined in in Rule 405 of the Securities Act of 1933 (§230.405
of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging
growth company ☒
If
an emerging growth company, indicate by checkmark if the registrant has elected not to use the extended transition period for complying
with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.
Item
2.02 Results of Operations and Financial Condition.
On
March 11, 2024, Cadrenal Therapeutics, Inc., a Delaware corporation (the “Company”), issued a press release that included
financial information for the fiscal year ended December 31, 2023. A copy of the press release is attached as Exhibit 99.1 to this Current
Report on Form 8-K.
The
information in this Item 2.02 and in the press release attached as Exhibit 99.1 to this Current Report on Form 8-K shall not be deemed
to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the
liabilities of that section or Sections 11 and 12(a)(2) of the Securities Act of 1933, as amended. The information contained in this
Item 2.02 and in the press release attached as Exhibit 99.1 to this Current Report on Form 8-K shall not be incorporated by reference
into any filing with the U.S. Securities and Exchange Commission made by the Company, whether made before or after the date hereof, regardless
of any general incorporation language in such filing.
Item
9.01 Financial Statements and Exhibits.
(d)
Exhibits
The
following exhibits are furnished with this Current Report on Form 8-K:
SIGNATURES
Pursuant
to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by
the undersigned hereunto duly authorized.
Dated: March 11, 2024 |
CADRENAL THERAPEUTICS, INC. |
|
|
|
By: |
/s/
Quang Pham |
|
Name: |
Quang Pham |
|
Title: |
Chairman and Chief Executive Officer |
2
Exhibit 99.1
Cadrenal Therapeutics Provides Fourth Quarter
2023 Corporate Update
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. |
| o | 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
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