false
0001946563
DC
0001946563
2024-07-25
2024-07-25
0001946563
SXTP:CommonStockParValue0.0001Member
2024-07-25
2024-07-25
0001946563
SXTP:WarrantsEachWarrantToPurchaseOneShareOfCommonStockMember
2024-07-25
2024-07-25
iso4217:USD
xbrli:shares
iso4217:USD
xbrli:shares
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:
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.
###
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)
|
Local Phone Number |
327-5422
|
Written Communications |
false
|
Soliciting Material |
false
|
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
|
X |
- DefinitionBoolean flag that is true when the XBRL content amends previously-filed or accepted submission.
+ References
+ Details
Name: |
dei_AmendmentFlag |
Namespace Prefix: |
dei_ |
Data Type: |
xbrli:booleanItemType |
Balance Type: |
na |
Period Type: |
duration |
|
X |
- DefinitionFor the EDGAR submission types of Form 8-K: the date of the report, the date of the earliest event reported; for the EDGAR submission types of Form N-1A: the filing date; for all other submission types: the end of the reporting or transition period. The format of the date is YYYY-MM-DD.
+ References
+ Details
Name: |
dei_DocumentPeriodEndDate |
Namespace Prefix: |
dei_ |
Data Type: |
xbrli:dateItemType |
Balance Type: |
na |
Period Type: |
duration |
|
X |
- DefinitionThe type of document being provided (such as 10-K, 10-Q, 485BPOS, etc). The document type is limited to the same value as the supporting SEC submission type, or the word 'Other'.
+ References
+ Details
Name: |
dei_DocumentType |
Namespace Prefix: |
dei_ |
Data Type: |
dei:submissionTypeItemType |
Balance Type: |
na |
Period Type: |
duration |
|
X |
- DefinitionAddress Line 1 such as Attn, Building Name, Street Name
+ References
+ Details
Name: |
dei_EntityAddressAddressLine1 |
Namespace Prefix: |
dei_ |
Data Type: |
xbrli:normalizedStringItemType |
Balance Type: |
na |
Period Type: |
duration |
|
X |
- DefinitionAddress Line 2 such as Street or Suite number
+ References
+ Details
Name: |
dei_EntityAddressAddressLine2 |
Namespace Prefix: |
dei_ |
Data Type: |
xbrli:normalizedStringItemType |
Balance Type: |
na |
Period Type: |
duration |
|
X |
- Definition
+ References
+ Details
Name: |
dei_EntityAddressCityOrTown |
Namespace Prefix: |
dei_ |
Data Type: |
xbrli:normalizedStringItemType |
Balance Type: |
na |
Period Type: |
duration |
|
X |
- DefinitionCode for the postal or zip code
+ References
+ Details
Name: |
dei_EntityAddressPostalZipCode |
Namespace Prefix: |
dei_ |
Data Type: |
xbrli:normalizedStringItemType |
Balance Type: |
na |
Period Type: |
duration |
|
X |
- DefinitionName of the state or province.
+ References
+ Details
Name: |
dei_EntityAddressStateOrProvince |
Namespace Prefix: |
dei_ |
Data Type: |
dei:stateOrProvinceItemType |
Balance Type: |
na |
Period Type: |
duration |
|
X |
- DefinitionA unique 10-digit SEC-issued value to identify entities that have filed disclosures with the SEC. It is commonly abbreviated as CIK.
+ ReferencesReference 1: http://www.xbrl.org/2003/role/presentationRef -Publisher SEC -Name Exchange Act -Number 240 -Section 12 -Subsection b-2
+ Details
Name: |
dei_EntityCentralIndexKey |
Namespace Prefix: |
dei_ |
Data Type: |
dei:centralIndexKeyItemType |
Balance Type: |
na |
Period Type: |
duration |
|
X |
- DefinitionIndicate if registrant meets the emerging growth company criteria.
+ ReferencesReference 1: http://www.xbrl.org/2003/role/presentationRef -Publisher SEC -Name Exchange Act -Number 240 -Section 12 -Subsection b-2
+ Details
Name: |
dei_EntityEmergingGrowthCompany |
Namespace Prefix: |
dei_ |
Data Type: |
xbrli:booleanItemType |
Balance Type: |
na |
Period Type: |
duration |
|
X |
- DefinitionCommission file number. The field allows up to 17 characters. The prefix may contain 1-3 digits, the sequence number may contain 1-8 digits, the optional suffix may contain 1-4 characters, and the fields are separated with a hyphen.
+ References
+ Details
Name: |
dei_EntityFileNumber |
Namespace Prefix: |
dei_ |
Data Type: |
dei:fileNumberItemType |
Balance Type: |
na |
Period Type: |
duration |
|
X |
- DefinitionTwo-character EDGAR code representing the state or country of incorporation.
+ References
+ Details
Name: |
dei_EntityIncorporationStateCountryCode |
Namespace Prefix: |
dei_ |
Data Type: |
dei:edgarStateCountryItemType |
Balance Type: |
na |
Period Type: |
duration |
|
X |
- DefinitionThe exact name of the entity filing the report as specified in its charter, which is required by forms filed with the SEC.
+ ReferencesReference 1: http://www.xbrl.org/2003/role/presentationRef -Publisher SEC -Name Exchange Act -Number 240 -Section 12 -Subsection b-2
+ Details
Name: |
dei_EntityRegistrantName |
Namespace Prefix: |
dei_ |
Data Type: |
xbrli:normalizedStringItemType |
Balance Type: |
na |
Period Type: |
duration |
|
X |
- DefinitionThe Tax Identification Number (TIN), also known as an Employer Identification Number (EIN), is a unique 9-digit value assigned by the IRS.
+ ReferencesReference 1: http://www.xbrl.org/2003/role/presentationRef -Publisher SEC -Name Exchange Act -Number 240 -Section 12 -Subsection b-2
+ Details
Name: |
dei_EntityTaxIdentificationNumber |
Namespace Prefix: |
dei_ |
Data Type: |
dei:employerIdItemType |
Balance Type: |
na |
Period Type: |
duration |
|
X |
- DefinitionLocal phone number for entity.
+ References
+ Details
Name: |
dei_LocalPhoneNumber |
Namespace Prefix: |
dei_ |
Data Type: |
xbrli:normalizedStringItemType |
Balance Type: |
na |
Period Type: |
duration |
|
X |
- DefinitionBoolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act.
+ ReferencesReference 1: http://www.xbrl.org/2003/role/presentationRef -Publisher SEC -Name Exchange Act -Number 240 -Section 13e -Subsection 4c
+ Details
Name: |
dei_PreCommencementIssuerTenderOffer |
Namespace Prefix: |
dei_ |
Data Type: |
xbrli:booleanItemType |
Balance Type: |
na |
Period Type: |
duration |
|
X |
- DefinitionBoolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act.
+ ReferencesReference 1: http://www.xbrl.org/2003/role/presentationRef -Publisher SEC -Name Exchange Act -Number 240 -Section 14d -Subsection 2b
+ Details
Name: |
dei_PreCommencementTenderOffer |
Namespace Prefix: |
dei_ |
Data Type: |
xbrli:booleanItemType |
Balance Type: |
na |
Period Type: |
duration |
|
X |
- DefinitionTitle of a 12(b) registered security.
+ ReferencesReference 1: http://www.xbrl.org/2003/role/presentationRef -Publisher SEC -Name Exchange Act -Number 240 -Section 12 -Subsection b
+ Details
Name: |
dei_Security12bTitle |
Namespace Prefix: |
dei_ |
Data Type: |
dei:securityTitleItemType |
Balance Type: |
na |
Period Type: |
duration |
|
X |
- DefinitionName of the Exchange on which a security is registered.
+ ReferencesReference 1: http://www.xbrl.org/2003/role/presentationRef -Publisher SEC -Name Exchange Act -Number 240 -Section 12 -Subsection d1-1
+ Details
Name: |
dei_SecurityExchangeName |
Namespace Prefix: |
dei_ |
Data Type: |
dei:edgarExchangeCodeItemType |
Balance Type: |
na |
Period Type: |
duration |
|
X |
- DefinitionBoolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as soliciting material pursuant to Rule 14a-12 under the Exchange Act.
+ ReferencesReference 1: http://www.xbrl.org/2003/role/presentationRef -Publisher SEC -Name Exchange Act -Number 240 -Section 14a -Subsection 12
+ Details
Name: |
dei_SolicitingMaterial |
Namespace Prefix: |
dei_ |
Data Type: |
xbrli:booleanItemType |
Balance Type: |
na |
Period Type: |
duration |
|
X |
- DefinitionTrading symbol of an instrument as listed on an exchange.
+ References
+ Details
Name: |
dei_TradingSymbol |
Namespace Prefix: |
dei_ |
Data Type: |
dei:tradingSymbolItemType |
Balance Type: |
na |
Period Type: |
duration |
|
X |
- DefinitionBoolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as written communications pursuant to Rule 425 under the Securities Act.
+ ReferencesReference 1: http://www.xbrl.org/2003/role/presentationRef -Publisher SEC -Name Securities Act -Number 230 -Section 425
+ Details
Name: |
dei_WrittenCommunications |
Namespace Prefix: |
dei_ |
Data Type: |
xbrli:booleanItemType |
Balance Type: |
na |
Period Type: |
duration |
|
X |
- Details
Name: |
us-gaap_StatementClassOfStockAxis=SXTP_CommonStockParValue0.0001Member |
Namespace Prefix: |
|
Data Type: |
na |
Balance Type: |
|
Period Type: |
|
|
X |
- Details
Name: |
us-gaap_StatementClassOfStockAxis=SXTP_WarrantsEachWarrantToPurchaseOneShareOfCommonStockMember |
Namespace Prefix: |
|
Data Type: |
na |
Balance Type: |
|
Period Type: |
|
|
60 Degrees Pharmaceuticals (NASDAQ:SXTP)
Historical Stock Chart
From Oct 2024 to Nov 2024
60 Degrees Pharmaceuticals (NASDAQ:SXTP)
Historical Stock Chart
From Nov 2023 to Nov 2024