SXTP 60 Degrees Pharmaceuticals Inc

 

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):

July 25, 2024

 

60 DEGREES PHARMACEUTICALS, INC.

(Exact name of registrant as specified in its charter)

 

Delaware		001-41719		45-2406880
(State or other jurisdiction of Incorporation)		(Commission File Number)		(IRS Employer Identification Number)

 

1025 Connecticut Avenue NW, Suite 1000 Washington, D.C.		20036
(Address of registrant’s principal executive office)		(Zip code)

 

(202) 327-5422

(Registrant’s telephone number, including area code)

 

Not Applicable

(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 the 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 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 symbol(s)		Name of each exchange on which registered
Common Stock, par value $0.0001		SXTP		The Nasdaq Stock Market LLC
Warrants, each warrant to purchase one share of Common Stock		SXTPW		The Nasdaq Stock Market LLC

 

Indicate by check mark whether the registrant is an emerging growth company as defined 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 check mark 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 8.01. Other Events.

 

On July 25, 2024, 60 Degrees Pharmaceuticals, Inc. (the “Company”) issued a press release announcing that it was awarded a contract, valued at $311,862, with the United States Army Medical Materiel Development Activity to facilitate commercial validation of a new bottle and replacement blister packaging of ARAKODA® (tafenoquine), the Company’s U.S. Food and Drug Administration-approved product indicated for malaria prevention. This initiative is critical for ensuring the continued procurement by the U.S. government.

 

The information set forth under this Item 8.01, including Exhibit 99.1, shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such a filing.

 

Item 9.01 Financial Statements and Exhibits.

 

(d) Exhibits.

 

The following exhibits are being filed herewith:

 

Exhibit No.		Description
99.1		Press Release of 60 Degrees Pharmaceuticals, Inc. dated as of July 25, 2024.
104		Cover Page Interactive Data File (embedded within the Inline XBRL document)

   

 

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.

 

Date: July 26, 2024	60 DEGREES PHARMACEUTICALS, INC.
	By:	/s/ Geoffrey Dow
	Name:	Geoffrey Dow
	Title:	Chief Executive Officer and President

 

 

Exhibit 99.1

 

 

60 Degrees Pharmaceuticals Awarded Contract with U.S. Army for ARAKODA^® Supply Chain Upgrade Support

 

·

60 Degrees Pharmaceuticals has been awarded a contract with the United States Army Medical Materiel Development Activity to facilitate commercial validation of new bottle and replacement blister packaging of ARAKODA® (tafenoquine), the Company’s FDA-approved product indicated for malaria prevention

·

Anticipating increasing ARAKODA sales volume in 2024, the Company increased the commercial batch size of ARAKODA in Q1 2024

·

Q1 2024 ARAKODA sales revenue increased 515% year-over-year to $105.7 thousand

 

WASHINGTON, D.C., July 25, 2024 – 60 Degrees Pharmaceuticals, Inc (NASDAQ: SXTP; SXTPW) (the “Company”), a pharmaceutical company focused on developing new medicines for infectious diseases, announced today that it has been awarded a fixed-price contract with the United States Army Medical Materiel Development Activity to support commercial validation of new bottle and replacement blister packaging of ARAKODA^® (tafenoquine), the Company’s malaria prevention product.

 

This follows the implementation of an increased tablet compression batch size in Q1 2024, planned in anticipation of increasing sales volume in 2024. Recently, 60 Degrees Pharmaceuticals announced that Q1 2024 ARAKODA net sales revenues increased 515% year-over-year to $105.7 thousand.

 

“Supply chain upgrade support from the United States Army Medical Materiel Development Activity is most welcome and important to our primary commercial goal of ensuring a sustainable supply of ARAKODA for our civilian and military customers in the U.S.,” said Chief Executive Officer of 60 Degrees Pharmaceuticals, Geoff Dow. “We are very proud of our uninterrupted supply of ARAKODA to the U.S. market, even in light of the earlier impact of the pandemic on international travel. We anticipate that, increasingly and over time, the U.S. healthcare provider community will recognize the advantages of using ARAKODA for malaria prevention. Also, the potential life-saving role the product may play in the treatment of all forms of babesiosis in the future is certainly very exciting.”

 

Babesiosis is a steadily emerging, tick-borne disease transmitted through the bite of the black-legged (deer) tick, the vector that spreads Lyme disease. An orphan disease, babesiosis may be life-threatening in elderly and immunosuppressed patients.

 

ARAKODA is indicated for the prophylaxis of malaria in patients aged 18 years and older. Tafenoquine is approved for malaria prophylaxis in the United States under the product name ARAKODA^®. The safety of the approved regimen of tafenoquine for malaria prophylaxis has been assessed in five separate randomized, double-blind, active comparator or placebo-controlled trials for durations of up to six months. Tafenoquine has not been proven to be effective for treatment or prevention of babesiosis and is not approved by the U.S. Food and Drug Administration for such an indication.

 

 

About ARAKODA® (tafenoquine)

Tafenoquine was discovered by Walter Reed Army Institute of Research with funding from the United States Army Medical Materiel Development Activity. Tafenoquine was approved for malaria prophylaxis in 2018 in the United States as ARAKODA® and in Australia as KODATEF®. Both were commercially launched in 2019 and are currently distributed through pharmaceutical wholesaler networks in each respective country. They are available at retail pharmacies as a prescription-only malaria prevention drug.

About 60 Degrees Pharmaceuticals, Inc.

60 Degrees Pharmaceuticals, Inc., founded in 2010, specializes in developing and marketing new medicines for the treatment and prevention of infectious diseases that affect the lives of millions of people. 60 Degrees Pharmaceuticals, Inc. achieved FDA approval of its lead product, ARAKODA® (tafenoquine), for malaria prevention, in 2018. 60 Degrees Pharmaceuticals, Inc. also collaborates with prominent research organizations in the U.S., Australia, and Singapore. The 60 Degrees Pharmaceuticals, Inc. mission has been supported through in-kind funding from the U.S. Department of Defense and private institutional investors including Knight Therapeutics Inc., a Canadian-based pan-American specialty pharmaceutical company. 60 Degrees Pharmaceuticals, Inc. is headquartered in Washington D.C., with a majority-owned subsidiary in Australia. Learn more at www.60degreespharma.com.

 

The statements contained herein may include prospects, statements of future expectations and other forward-looking statements that are based on management's current views and assumptions and involve known and unknown risks and uncertainties. Actual results, performance or events may differ materially from those expressed or implied in such forward-looking statements. The statements expressed herein are those of 60 Degrees Pharmaceuticals, Inc. and do not necessarily represent those of the U.S. Department of Defense.

Cautionary Note Regarding Forward-Looking Statements

This press release may contain “forward-looking statements” within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. Forward-looking statements reflect the current view about future events. When used in this press release, the words “anticipate,” “believe,” “estimate,” “expect,” “future,” “intend,” “plan,” or the negative of these terms and similar expressions, as they relate to us or our management, identify forward-looking statements. Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based only on our current beliefs, expectations and assumptions regarding the future of our business, future plans and strategies, projections, anticipated events and trends, the economy, activities of regulators and future regulations and other future conditions. Because forward-looking statements relate to the future, they are subject to inherent uncertainties, risks and changes in circumstances that are difficult to predict and many of which are outside of our control. Our actual results and financial condition may differ materially from those indicated in the forward-looking statements. Therefore, you should not rely on any of these forward-looking statements. Important factors that could cause our actual results and financial condition to differ materially from those indicated in the forward-looking statements include, among others, the following: there is substantial doubt as to our ability to continue on a going-concern basis; we might not be eligible for Australian government research and development tax rebates; if we are not able to successfully develop, obtain FDA approval for, and provide for the commercialization of non-malaria prevention indications for tafenoquine (ARAKODA® or other regimen) or Celgosivir in a timely manner, we may not be able to expand our business operations; we may not be able to successfully conduct planned clinical trials; and we have no manufacturing capacity which puts us at risk of lengthy and costly delays of bringing our products to market. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company’s filings with the Securities and Exchange Commission (“SEC”), including the information contained in our Annual Report on Form 10-K filed with the SEC on April 1, 2024, and our subsequent SEC filings. Investors and security holders are urged to read these documents free of charge on the SEC’s web site at www.sec.gov. As a result of these matters, changes in facts, assumptions not being realized or other circumstances, the Company’s actual results may differ materially from the expected results discussed in the forward-looking statements contained in this press release. Any forward-looking statement made by us in this press release is based only on information currently available to us and speaks only as of the date on which it is made. We undertake no obligation to publicly update any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise.

 

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Media Contact:

Sheila A. Burke

SheilaBurke-consultant@60degreespharma.com

(484) 667-6330

 

Investor Contact:

Patrick Gaynes

patrickgaynes@60degreespharma.com

(310) 989-5666

 

v3.24.2

Cover	Jul. 25, 2024
Document Type	8-K
Amendment Flag	false
Document Period End Date	Jul. 25, 2024
Entity File Number	001-41719
Entity Registrant Name	60 DEGREES PHARMACEUTICALS, INC.
Entity Central Index Key	0001946563
Entity Tax Identification Number	45-2406880
Entity Incorporation, State or Country Code	DE
Entity Address, Address Line One	1025 Connecticut Avenue NW
Entity Address, Address Line Two	Suite 1000
Entity Address, City or Town	Washington
Entity Address, State or Province	DC
Entity Address, Postal Zip Code	20036
City Area Code	(202)
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Pre-commencement Tender Offer	false
Pre-commencement Issuer Tender Offer	false
Entity Emerging Growth Company	true
Elected Not To Use the Extended Transition Period	false
Common Stock, par value $0.0001
Title of 12(b) Security	Common Stock, par value $0.0001
Trading Symbol	SXTP
Security Exchange Name	NASDAQ
Warrants, each warrant to purchase one share of Common Stock
Title of 12(b) Security	Warrants, each warrant to purchase one share of Common Stock
Trading Symbol	SXTPW
Security Exchange Name	NASDAQ

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