The efficacy and safety of tafenoquine in treating human babesiosis will be evaluated in a randomized, double-blind, placebo-controlled trial conducted at Tufts Medical Center in Boston.Endpoints are time to sustained clinical resolution of symptoms of babesiosis, and molecular cure as determined by an FDA-approved nucleic acid test (NAT).Study is the world's first and only clinical trial evaluating tafenoquine in human babesiosis patients. WASHINGTON, June 27, 2024 (GLOBE NEWSWIRE) -- 60 Degrees Pharmaceuticals, Inc. (NASDAQ:SXTP, SXTPW))) (the "Company" or 60 Degrees Pharmaceuticals), a pharmaceutical company focused on developing new medicines for infectious diseases, announced that th
With the tafenoquine for acute babesiosis orphan drug designation, 60 Degrees Pharmaceuticals now qualifies for certain incentives, including market exclusivity, tax credits, and exemption from certain FDA filing fees.60 Degrees Pharmaceuticals recently announced it has entered into an agreement with Tufts Medical Center in Boston to conduct the world's first clinical trial evaluating the efficacy and safety of tafenoquine in treating human babesiosis patients.FDA orphan drug designation is granted for therapeutic candidates that may prevent or treat a rare disease or condition, such as acute babesiosis. WASHINGTON, June 11, 2024 (GLOBE NEWSWIRE) -- 60 Degrees Pharmaceuticals, Inc. (NAS
60 Degrees Pharmaceuticals has entered an agreement with Tufts Medical Center to conduct a clinical trial that will evaluate the safety and efficacy of tafenoquine for the treatment of babesiosis in humansThe study will be the world's first clinical trial to evaluate tafenoquine in human babesiosis patientsEnrollment will begin after a site initiation visit in Boston on June 13, 2024Agreements are being negotiated with two other prominent university hospitals to expand recruitment in the Northeast U.S. where the incidence of babesiosis has been increasing; babesiosis, a tick-borne and potentially life-threatening illness, is an orphan diseaseCase studies in the medical literature suggest tha
Long-term chronic fatigue syndrome (CFS) symptoms can be triggered by certain prior acute infectionsProminent researchers/clinicians in the tick-borne disease scientific community postulate that latent Babesia spp infections may trigger CFS symptomsPlanned study at North Carolina State College of Veterinary Medicine will assess whether Babesia spp parasites are present in samples from patients with chronic fatigue/neurologic symptoms by PCRCDC estimates CFS affects 3.3 million Americans WASHINGTON, May 20, 2024 (GLOBE NEWSWIRE) -- 60 Degrees Pharmaceuticals, Inc. (NASDAQ:SXTP, SXTPW))) (the "Company"), a pharmaceutical company focused on developing new medicines for infectious diseases,
Q1 2024 net product revenues increased 515% year-over-year to $105.7 thousand.Gross profit increased from ($55.9 thousand) to $51.0 thousand. WASHINGTON, May 15, 2024 (GLOBE NEWSWIRE) -- 60 Degrees Pharmaceuticals, Inc. (NASDAQ:SXTP, SXTPW))) (the "Company"), a pharmaceutical company focused on developing new medicines for infectious diseases, reported today their financial results for the first fiscal quarter of the 2024 year, ended March 31, 2024. Financial Highlights for the Quarter Ended March 31, 2024: Net product revenues increased approximately 515% from $17.17 thousand for the first quarter of 2023 to approximately $105.7 thousand for first quarter of 2024; the Company credits g
The U.S. medical scientific community is calling for clinical studies to expand shared understanding of babesiosis, an emerging tick-borne illness.The upcoming 60 Degrees Pharma clinical trial of tafenoquine in treating babesiosis will be the first and only such study to date.Enrollment is planned to begin in summer 2024.The Journal of Infectious Diseases has published a letter outlining the planned trial protocol. WASHINGTON, May 08, 2024 (GLOBE NEWSWIRE) -- 60 Degrees Pharmaceuticals, Inc. (NASDAQ:SXTP, SXTPW))) (the "Company"), a pharmaceutical company focused on developing new medicines for infectious diseases, announced today that a letter, titled Trial Planned to Evaluate Safety
Trial planning and execution to proceed as planned WASHINGTON, May 02, 2024 (GLOBE NEWSWIRE) -- 60 Degrees Pharmaceuticals, Inc. (NASDAQ:SXTP, SXTPW))) (the "Company"), a pharmaceutical company focused on developing new medicines for infectious diseases, announced today that the U.S. Food and Drug Administration (FDA) has provided comments on the protocol of a planned clinical trial that will study the use of tafenoquine in treating babesiosis. Babesiosis, a potentially life-threatening disease in immunosuppressed patients, is a tick-borne illness steadily emerging in the United States. The FDA had some questions and recommendations that will be addressed. Nothing in the comments require
Study to be conducted by North Carolina State University in 2024Standard of care fails in 20 percent of cases and drug resistance is a problemStandard of care is expensive WASHINGTON, April 03, 2024 (GLOBE NEWSWIRE) -- 60 Degrees Pharmaceuticals, Inc. (NASDAQ:SXTP, SXTPW))) (or the "Company"), a pharmaceutical company focused on developing new medicines for infectious diseases, announced today that the Company will sponsor a pilot study of tafenoquine, the active molecule in its U.S. Food and Drug Administration (FDA)-approved human malaria prevention medication, ARAKODA®, for the treatment of babesiosis in dogs. The study will support a broader effort now being led by 60 Degrees Pharmace
WASHINGTON, March 14, 2024 (GLOBE NEWSWIRE) -- 60 Degrees Pharmaceuticals, Inc., (NASDAQ:SXTP, SXTPW))) ("60 Degrees Pharmaceuticals" or the "Company"), a pharmaceutical company focused on developing new medicines for infectious diseases, today announced that the U.S. Food and Drug Administration (FDA) has communicated its intention to send any comments regarding the Company's babesiosis trial within the month of April, 2024, rather than March, 2024 as anticipated by the Company. The protocol submission mechanism as directed by the FDA, i.e., under the Company's existing (rather than a new) Investigational New Drug application, technically does not require a response from the FDA within a
Candida auris (C. auris) is a dangerous drug-resistant fungal pathogen emerging in U.S. hospitalsTafenoquine's presumed mode of action against C. auris is differentiated from standard of care treatmentMonash University will conduct the studies beginning in second quarter of 2024 WASHINGTON, Feb. 20, 2024 (GLOBE NEWSWIRE) -- 60 Degrees Pharmaceuticals, Inc. (the "Company," "60P" or "60 Degrees Pharmaceuticals") (NASDAQ:SXTP, SXTPW))), specialists in developing and marketing medicines for infectious diseases, today announced it will, through its majority-owned subsidiary 60P Australia Pty Ltd, sponsor a series of animal studies to investigate whether single dose parenteral administratio
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The efficacy and safety of tafenoquine in treating human babesiosis will be evaluated in a randomized, double-blind, placebo-controlled trial conducted at Tufts Medical Center in Boston.Endpoints are time to sustained clinical resolution of symptoms of babesiosis, and molecular cure as determined by an FDA-approved nucleic acid test (NAT).Study is the world's first and only clinical trial evaluating tafenoquine in human babesiosis patients.
With the tafenoquine for acute babesiosis orphan drug designation, 60 Degrees Pharmaceuticals now qualifies for certain incentives, including market exclusivity, tax credits, and exemption from certain FDA filing fees.60 Degrees Pharmaceuticals recently announced it has entered into an agreement with Tufts Medical Center in Boston to conduct the world's first clinical trial evaluating the efficacy and safety of tafenoquine in treating human babesiosis patients.FDA orphan drug designation is granted for therapeutic candidates that may prevent or treat a rare disease or condition, such as acute babesiosis.
HC Wainwright & Co. analyst Edward White reiterates 60 Degrees (NASDAQ:SXTP) with a Neutral.
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60 Degrees Pharmaceuticals has entered an agreement with Tufts Medical Center to conduct a clinical trial that will evaluate the safety and efficacy of tafenoquine for the treatment of babesiosis in humans The study will be the world's first clinical trial to evaluate tafenoquine in human babesiosis patientsEnrollment will begin after a site initiation visit in Boston on June 13, 2024Agreements are being negotiated with two other prominent university hospitals to expand recruitment in the Northeast U.S. where the incidence of babesiosis has been increasing; babesiosis, a tick-borne and potentially life-threatening illness, is an orphan diseaseCase studies in the medical literature suggest th
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60 Degrees (NASDAQ:SXTP) reported quarterly earnings of $0.03 per share. This is a 102.65 percent increase over losses of $(1.13) per share from the same period last year. The company reported $80.66 thousand in sales this quarter. This is a 256.14 percent increase over sales of $(51.66 thousand) the same period last year.
WASHINGTON, June 27, 2024 (GLOBE NEWSWIRE) -- 60 Degrees Pharmaceuticals, Inc. (NASDAQ:SXTP, SXTPW))) (the "Company" or 60 Degrees Pharmaceuticals), a pharmaceutical company focused on developing new medicines for infectious diseases, announced that the first patient has been enrolled in a randomized, double-blind, placebo-controlled clinical trial to evaluate the efficacy and safety of tafenoquine in treating babesiosis in humans. The patient was enrolled at Tufts Medical Center in Boston.
The study will enroll at least 24, and as many as 33 people. It is the world's first and only clinical trial evaluating the efficacy and safety of tafenoquine in human patients who have been diagnosed with acute babesiosis.
"With the first patient now enrolled in this groundbreaking clinical study, we have moved into a key phase of development with tafenoquine as a potential new treatment option in treating babesiosis," said Geoff Dow, PhD, chief executive officer at 60 Degrees Pharmaceuticals. "Given both the growing prevalence of babesiosis and the difficulty of quickly differentiating it from other illnesses seen in the clinic, we anticipate the numbers of people hospitalized with this serious tick-borne illness will continue to rise over time. In such cases, babesiosis can certainly become life-threatening. Our goal is for tafenoquine to play an important role in safely and effectively resolving babesiosis in those patients."
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.
The Company is in discussions with other prominent university hospitals to participate in the tafenoquine for babesiosis study.
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.
60 Degrees Pharma recently announced tafenoquine has been designated as an orphan drug by the U.S. Food and Drug Administration.
About the Tafenoquine in Babesiosis Study
The study is a randomized, double-blind, placebo-controlled trial enrolling patients in multiple sites in the Northeast U.S. comparing the safety and efficacy of tafenoquine versus placebo in patients hospitalized for babesiosis, i.e., acute cases. The two main study endpoints will be time to sustained clinical resolution of symptoms of babesiosis and molecular cure as determined by an FDA-approved nucleic acid test (NAT). At least 24, and as many as 33 patients, will be recruited before an interim analysis is conducted. Sufficient enrollment capacity is planned to allow all these patients to be recruited during the 2024 tick season (June to September) if caseload is high. The interim analysis will include both a test of significance as well as size re-estimation to allow additional recruitment if required. The study will be conducted at three hospitals in the northeastern United States.
About ARAKODA® (tafenoquine)
Tafenoquine was discovered by Walter Reed Army Institute of Research. 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. According to the Centers for Disease Control and Prevention, the long terminal half-life of tafenoquine, which is approximately 16 days, may offer potential advantages in less-frequent dosing for prophylaxis for malaria. ARAKODA is not suitable for everyone, and patients and prescribers should review the Important Safety Information below. Individuals at risk of contracting malaria are prescribed ARAKODA 2 x 100 mg tablets once per day for three days (the loading phase) prior to travel to an area of the world where malaria is endemic, 2 x 100 mg tablets weekly for up to six months during travel, then 2 x 100 mg in the week following travel.
ARAKODA® (tafenoquine) Important Safety Information:
ARAKODA® is an antimalarial indicated for the prophylaxis of malaria in patients aged 18 years of age and older.
Contraindications
ARAKODA® should not be administered to:
Warnings and Precautions
Hemolytic Anemia: G6PD testing must be performed before prescribing ARAKODA® due to the risk of hemolytic anemia. Monitor patients for signs or symptoms of hemolysis.
G6PD Deficiency in Pregnancy or Lactation: ARAKODA® may cause fetal harm when administered to a pregnant woman with a G6PD-deficient fetus. ARAKODA® is not recommended during pregnancy. A G6PD-deficient infant may be at risk for hemolytic anemia from exposure to ARAKODA® through breast milk. Check infant's G6PD status before breastfeeding begins.
Methemoglobinemia: Asymptomatic elevations in blood methemoglobin have been observed. Initiate appropriate therapy if signs or symptoms of methemoglobinemia occur.
Psychiatric Effects: Serious psychotic adverse reactions have been observed in patients with a history of psychosis or schizophrenia, at doses different from the approved dose. If psychotic symptoms (hallucinations, delusions, or grossly disorganized thinking or behavior) occur, consider discontinuation of ARAKODA® therapy and evaluation by a mental health professional as soon as possible.
Hypersensitivity Reactions: Serious hypersensitivity reactions have been observed with administration of ARAKODA®. If hypersensitivity reactions occur, institute appropriate therapy.
Delayed Adverse Reactions: Due to the long half-life of ARAKODA® (approximately 17 days), psychiatric effects, hemolytic anemia, methemoglobinemia, and hypersensitivity reactions may be delayed in onset and/or duration.
Adverse Reactions: The most common adverse reactions (incidence greater than or equal to 1 percent) were: headache, dizziness, back pain, diarrhea, nausea, vomiting, increased alanine aminotransferase, motion sickness, insomnia, depression, abnormal dreams, and anxiety.
Drug Interactions
Avoid co-administration with drugs that are substrates of organic cation transporter-2 or multidrug and toxin extrusion transporters.
Use in Specific Populations
Lactation: Advise women not to breastfeed a G6PD-deficient infant or infant with unknown G6PD status during treatment and for 3 months after the last dose of ARAKODA®.
To report SUSPECTED ADVERSE REACTIONS, contact 60 Degrees Pharmaceuticals, Inc. at 1- 888-834-0225 or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. The full prescribing information of ARAKODA® is located here.
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.
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 or patient recruitment in our trials might be slow or negligible; 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
[email protected]
(484) 667-6330
Investor Contact:
Patrick Gaynes
[email protected]
(310) 989-5666
MELBOURNE, Australia, Sept. 01, 2023 (GLOBE NEWSWIRE) -- Genetic Technologies Limited ((ASX: GTG, NASDAQ:GENE, "Company", "GTG")), a global leader in guideline driven genomics-based tests in health, wellness and serious disease is pleased to advise that RedChip Companies will air interviews with Genetic Technologies Limited (NASDAQ:GENE) and 60 Degrees Pharmaceuticals (60P) (NASDAQ:SXTP) on The RedChip Money Report®, a sponsored program on Bloomberg TV, this Saturday, September 2, at 7 p.m. Eastern Time (ET). Bloomberg TV is available in an estimated 73 million homes across the U.S. Access the interviews in their entirety at: • Genetic Technologies (NASDAQ:GENE): https://www.redchip.com/
ORLANDO, FL / ACCESSWIRE / September 1, 2023 / RedChip Companies will air interviews with Genetic Technologies Limited (NASDAQ:GENE) and 60 Degrees Pharmaceuticals (NASDAQ:SXTP) on The RedChip Money Report®, a sponsored program on Bloomberg TV, this Saturday, September 2, at 7 p.m. Eastern Time (ET). Bloomberg TV is available in an estimated 73 million homes across the U.S.Access the interviews in their entirety at:Genetic Technologies (NASDAQ:GENE): https://www.redchip.com/stocks/GENE60 Degrees Pharmaceuticals (NASDAQ:SXTP): https://www.redchip.com/stocks/SXTPAbout The RedChip Money Report®The RedChip Money Report® is produced by RedChip Companies Inc., an international Investor Relations a
ORLANDO, FL / ACCESSWIRE / July 21, 2023 / RedChip Companies will air interviews with 60 Degrees Pharmaceuticals, Inc. (NASDAQ:SXTP) and Unicycive Therapeutics, Inc. (NASDAQ:UNCY) on The RedChip Money Report® on Bloomberg TV, this Saturday, July 22, at 7 p.m. Eastern Time (ET). Bloomberg TV is available in an estimated 73 million homes across the U.S.Access the interviews in their entirety at:60 Degrees Pharmaceuticals (NASDAQ:SXTP): https://www.redchip.com/assets/access/sxtp_accessUnicycive Therapeutics (NASDAQ:UNCY): https://www.redchip.com/assets/access/uncy_accessAbout The RedChip Money Report®The RedChip Money Report® is produced by RedChip Companies Inc., an international Investor Rela
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4 - 60 DEGREES PHARMACEUTICALS, INC. (0001946563) (Issuer)
4 - 60 DEGREES PHARMACEUTICALS, INC. (0001946563) (Issuer)
4 - 60 DEGREES PHARMACEUTICALS, INC. (0001946563) (Issuer)
4 - 60 DEGREES PHARMACEUTICALS, INC. (0001946563) (Issuer)