Form 8-K - Current report

 

 

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): August 10, 2023

 

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)

 

[phone]

(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 August 10, 2023, Cadrenal Therapeutics, Inc., a Delaware corporation (the “Company”), issued a press release that included financial information for the fiscal quarter ended June 30, 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:

 

Exhibit Number		Exhibit Description
99.1		Press Release, issued by Cadrenal Therapeutics, Inc. on August 10, 2023
104		Cover Page Interactive Data File (the cover page XBRL tags are embedded within in the inline XBRL document)

 

1

 

 

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: August 10, 2023	CADRENAL THERAPEUTICS, INC.
	By:	/s/ Quang Pham
	Name:	Quang Pham
	Title:	Chairman and Chief Executive Officer

 

 

2

 

 

Exhibit 99.1

 

Cadrenal Therapeutics Provides Second Quarter 2023 Corporate Update

 

PONTE VEDRA, Fla., Aug. 10, 2023 /PRNewswire/ -- Cadrenal Therapeutics, Inc., (Nasdaq: CVKD) a biopharmaceutical company 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, today provided a corporate update in connection with the filing of its Quarterly Report on Form 10-Q for the quarter ended June 30, 2023. 

Recent Highlights

 

·

Expanded focus for tecarfarin development for patients with implanted medical devices such as left ventricular assist devices (LVADs) for heart diseases, an addressable market opportunity of approximately $600 million per year in the U.S.

  

·

Completed a $7.5 million private placement priced at-the-market under Nasdaq rules at a purchase price of $1.75 per share.

 

·

Appointed accomplished cardiovascular pharmaceutical executive Robert Lisicki to the board of directors.

 

·

Q2 2023 operating expenses (excluding non-cash items) totaled $835,000.

 

·

As of August 14, 2023, cash balances were $9.6 million.

 

“Over the past few months, it has become increasingly clear that the opportunity for tecarfarin reaches beyond patients with end-stage kidney disease (ESKD) and atrial fibrillation (AFib). A much larger opportunity exists where Vitamin K antagonists (warfarin) are prescribed, yet are unreliable and have failed to achieve sufficient anticoagulation,” commented Quang Pham, CEO of Cadrenal Therapeutics. “Based on our clinical data, extensive market research, and insights from key industry experts, we believe implanted medical devices for heart diseases, such as LVADs, could be a potential additional indication for tecarfarin.”

 

There are estimated to be over 14,000 patients in the U.S. with LVADs who struggle with stable anticoagulation provided by warfarin. Based on Company estimates, this is a potential addressable market opportunity of approximately $600 million per year in the U.S. The direct-acting oral anticoagulants such as Eliquis and Xarelto are not prescribed for these patients. Management estimates that the addressable market opportunity for ESKD and AFib is an additional $1 billion per year in the U.S.

 

Mr. Pham expanded, “Tecarfarin is specifically designed to solve warfarin’s metabolism problem via the cytochrome p450 pathway. Tecarfarin is metabolized via an alternate pathway that is abundant and essentially insaturable, providing a much more reliable pharmacokinetic profile. Key patient groups that incur irregular blood clotting could benefit from a new, and potentially more effective and safer, blood thinner like tecarfarin. Unlike other drug categories, such as cholesterol-lowering and high blood pressure, there have been no other blood thinners on the market since warfarin was approved in 1954. We look forward to advancing tecarfarin to fill what we believe is an important void in the market.”

 

Matthew Szot, CFO of Cadrenal Therapeutics, commented, “We successfully completed an important private placement financing, which was priced at the market under Nasdaq rules, with an institutional investor. As of August 14, 2023, our cash and cash equivalents totaled $9.6 million. This raise, coupled with our highly efficient expense management, has strengthened our balance sheet and provides capital and flexibility to continue to progress our path to regulatory approval and commercialization.”

 

 

 

 

ABOUT CADRENAL THERAPEUTICS, INC.

 

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 kidney disease, or ESKD, and atrial fibrillation, or AFib. Tecarfarin is specifically designed to leverage a different metabolism pathway than the oldest and most commonly prescribed Vitamin K antagonist (warfarin) used in the prevention of thrombosis. 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 approach that LVAD patients are a potential additional indication for tecarfarin, expanding the Company’s focus for tecarfarin within patients with implanted medical devices for heart diseases, the estimated 14,000 patients in the U.S. with LVADs who struggle with stable anticoagulation with warfarin, the estimated addressable market opportunity of approximately $600 million per year in the U.S., the estimated addressable market opportunity for ESKD and AFib of approximately $1 billion per year in the U.S. and advancing tecarfarin to fill an important void in the market.

 

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 within patients with implanted medical devices for heart diseases, the ability to penetrate the U.S. market for patients with LVADs who struggle with stable anticoagulation with warfarin, the ability to advance patient care in cardiorenal diseases 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

[e-mail]

 

Investors:

Lytham Partners, LLC

Robert Blum, Managing Partner

602-889-9700,

[e-mail]

 

 

 

Cover	Aug. 10, 2023
Cover [Abstract]
Document Type	8-K
Amendment Flag	false
Document Period End Date	Aug. 10, 2023
Entity File Number	001-41596
Entity Registrant Name	Cadrenal Therapeutics, Inc.
Entity Central Index Key	0001937993
Entity Tax Identification Number	88-0860746
Entity Incorporation, State or Country Code	DE
Entity Address, Address Line One	822 A1A North
Entity Address, Address Line Two	Suite 306
Entity Address, City or Town	Ponte Vedra
Entity Address, State or Province	FL
Entity Address, Postal Zip Code	32082
City Area Code	904
Local Phone Number	300-0701
Written Communications	false
Soliciting Material	false
Pre-commencement Tender Offer	false
Pre-commencement Issuer Tender Offer	false
Title of 12(b) Security	Common Stock, par value $0.001 per share
Trading Symbol	CVKD
Security Exchange Name	NASDAQ
Entity Emerging Growth Company	true
Elected Not To Use the Extended Transition Period	false

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