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SXTP Just Implemented a 1 for 5 Reverse Split, Drastically Reducing the Float
Due to a recent surge in demand for Arakoda® in the U.S. market, the Company submitted a regulatory discretion request to FDA in December 2024 to allow importation of Kodatef® (Australian-branded equivalent of Arakoda) to ensure continuous U.S. commercial supply. This was granted in February 2025, and Kodatef was made available for distribution on March 10, 2025, through a specialty pharmacy serving all 50 states
The Company is completing validation of two additional lots of Arakoda, to be released into the supply chain by early Q2 2025
READ THE INVESTOR PRESENTATION HERE
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Hello Everyone,
We have another company for you to look at for tomorrows session.
This one just completed a reverse split like the two we looked at last week that took off.
Pull up SXTP.
60 Degrees Pharmaceuticals, a growth-oriented biotech company, specializes in the development and commercialization of new therapies used to treat and prevent serious infectious diseases.
Cutting-edge biological science and applied research form the foundation of their highly-focused, advanced clinical strategy.
In 2019, 60P’s malaria prevention product, ARAKODA® (tafenoquine), was made commercially available after receipt of U.S. regulatory approval in 2018.
60P is addressing the unmet medical need associated with infectious diseases through the development and commercialization of new small molecule therapeutics. By focusing on synthetic drugs (made by chemists in labs, excluding biologics) with good safety profiles based on prior clinical studies, 60P believes it has a cost- effective path to new indications that capitalizes on existing research to reduce costs and risk. 60P is expanding its commercialization efforts related to ARAKODA (tafenoquine), an antimalarial indicated for prophylaxis of malaria in patients 18 years and older and approved by the FDA in 2018. In Q2 2023, sales of ARAKODA increased by 150% relative to the same period in 2022, at an accelerating growth rate.
60P is implementing clinical research programs to evaluate the utility of the ARAKODA regimen of tafenoquine for non-malaria disease indications, with an upcoming planned Phase 2a study of tafenoquine in hospitalized babesiosis patients, with the goal of requesting a pre-IND meeting with FDA before the end of 2023. According to Company estimates, 47,000 cases of babesiosis (infections caused by red blood cell parasites similar to malaria that are transmitted by deer tick bites) occur in the United States each year, and the incidence rate is increasing. Estimates are that 10% of Lyme disease patients are co-infected with babesiosis. 60P is also testing the viability of another product (Celgosivir) to determine whether to advance it into further clinical development and may seek to develop and license other molecules in the future.
60° PHARMACEUTICALS’ PIPELINE OF INFECTIOUS DISEASE MEDICINES & INDICATIONS60° Pharmaceuticals (60P)—a growth-oriented specialty pharmaceutical company—is putting cutting-edge biological science and applied research to use in furthering therapies for the prevention and treatment of infectious diseases. Currently 60P’s pipeline covers promising clinical development programs for COVID-19, babesiosis, dengue and other viral illnesses.
ARAKODA FULFILLING THE PROMISE OF ARAKODA By leveraging its successful completion of clinical development and FDA approval of ARAKODA® (tafenoquine) for malaria prevention and exclusive research and licensing agreements with the U. S. Army, and with promising new non-clinical and clinical data in hand, 60P is seeking to evaluate the utility of tafenoquine for additional indications.
COVID-19 THERAPEUTIC TREATMENT The ARAKODA regimen of tafenoquine has exhibited positive Phase II study data in patients with mild-moderate COVID-19 disease.* Trial data has been published in New Microbes and New Infections, a peer-reviewed, open-access journal.
The study evaluated the safety and efficacy of tafenoquine in patients with mild-moderate COVID-19 diseaseLarger studies are planned to evaluate tafenoquine efficacy in treating COVID-19TREATMENT OF BABESIOSIS Tafenoquine exhibits useful activity in animal models of babesiosis and according to case reports may have clinical utility in treatment of drug-resistant strains.*
In collaboration with leading U.S. institutions, 60P is planning a proof of concept clinical study to assess the utility of ARAKODA as a treatment for human babesiosis.TREATMENT & PREVENTION OF FUNGAL DISEASESIn vitro and in vivo studies demonstrate that tafenoquine is effective for treatment and prevention of fungi such as Pneumocystis and yeasts at concentrations/doses that are clinically relevant.1,2* Pneumocystis remains an important pathogen in organ transplant patients for whom the current standard of care is sub-optimal in some patient segments.3 Many infections caused by yeasts such as Candida auris are refractory to standard of care medications such as azoles, amphotericin B, and echinocandins.2
60P’S CELGOSIVIR60P is planning a clinical development campaign for the repositioning of celgosivir, a host-targeted glucosidase inhibitor that was developed separately by other sponsors for HIV and hepatitis C4, but never approved by regulators. Similar to other dengue antivirals, celgosivir has shown diminished activity in curing dengue infection in animal models when administered after animals become symptomatic. However, this issue was addressed by administering the same dose split into four doses per day rather than one or two doses per daty.5 Preliminary data suggest celgosivir may inhibit the replication of the virus that causes COVID-19 (SARS-CoV-2) in cell culture, the RSV virus in cell culture, and may protect the lungs from RSV infection in animals.*
60 Degrees Pharmaceuticals Announces 2024 Annual Results
- FY 2024 net product revenues increased 140% to $607.6 thousand.
- FY 2024 gross profit increased $443.8 thousand from ($221 thousand) to $222.8 thousand.
WASHINGTON, March 28, 2025 (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 2024 fiscal year, ended December 31, 2024.
Financial Highlights for the Fiscal Year Ended December 31, 2024:
- Net product revenues increased 140% from $253.6 thousand for fiscal year 2023 to $607.6 thousand for fiscal year 2024; the Company credits growth from domestic commercial sales of ARAKODA®.
- The Company achieved a gross profit of approximately $222.8 thousand in fiscal year 2024, compared to an approximate gross loss of $221 thousand in fiscal year 2023. Increased sales volume allowed the Company to overcome fixed cost of goods expense associated with the Drug Supply Chain Security Act that previously led to a gross loss.
- Operating expenses were approximately $10.0 million in fiscal year 2024, compared with approximately $4.9 million in fiscal year 2023. The increase in operating expenses was primarily due to a non-recurring non-cash Research and Development charge of $2.63 million, non-recurring non-cash delivery of research materials ($0.6 million) and Research and Development costs associated with the Company’s babesiosis clinical trial program ($1.36 million).
- Net loss attributable to common shareholders in calendar year 2024 was approximately $8.43 million, or $18.55 per share, compared with a net loss of approximately $3.925 million, or $59.18 per share in fiscal year 2023, representing a $4.505 million decline. This decline in profitability is mostly attributed to an increase in non-recurring non-cash Research and Development expenses of $3.23 million.
Recent Business Highlights
- Due to a recent surge in demand for Arakoda® in the U.S. market, the Company submitted a regulatory discretion request to FDA in December 2024 to allow importation of Kodatef® (Australian-branded equivalent of Arakoda) to ensure continuous U.S. commercial supply. This was granted in February 2025, and Kodatef was made available for distribution on March 10, 2025, through a specialty pharmacy serving all 50 states.
- The Company is completing validation of two additional lots of Arakoda, to be released into the supply chain by early Q2 2025.
- Preparations for the Company’s commercial pilot are complete. Outreach to physicians commenced on March 17, 2025.
- The Company commenced a randomized evaluation of tafenoquine versus placebo in hospitalized patients with babesiosis in 2024, randomizing N=6 of the minimum 24 patients required to trigger an interim endpoint (all completed the study). The Company recently increased its recruitment capacity for this study by establishing an additional clinical site at Brigham and Women’s Hospital. Interim analysis is expected in Q1 2026.
- We initiated an open label evaluation of Arakoda in immunosuppressed patients who have a diagnosis of relapsing/persistent babesiosis. The first patient was enrolled during Q1, 2025. Up to 15 patients in total will be enrolled.
- The epidemiological study sponsored by the Company, and conducted by North Carolina State University, is complete. The study evaluated the incidence of babesiosis by PCR and DNA sequencing in patients with persistent fatigue and neurological problems. Results of the study will be submitted to a peer-reviewed journal.
- The total prevalence of post-infectious syndromes (severe chronic fatigue, chronic fatigue syndrome, encephalomyelitis, long COVID, and post-treatment Lyme disease syndrome), and the potential contribution of Babesia infection to that burden of disease, is not known. The Company is conducting additional market research to determine the size of these market segments in the U.S., with a view to defining an upper limit on the potential prevalence of chronic babesiosis.
- The Company has secured IRB (ethics) approval for an open label evaluation of Arakoda in patients with severe fatigue and a presumptive diagnosis of babesiosis. The Company is now establishing the feasibility and cost of conducting such a study.
Sixty Degrees Pharmaceuticals to Ensure Continuity of Tafenoquine Supply in U.S. by Importing Limited Quantity of KODATEF®
February 11, 2025 at 12:59 PM EST
WASHINGTON, Feb. 11, 2025 (GLOBE NEWSWIRE) — 60 Degrees Pharmaceuticals, Inc. (NASDAQ: SXTP; SXTPW) (“60 Degrees” or the “Company”), pharmaceutical company today announced that the United States Food and Drug Administration (FDA) does not object to the Company’s plan to import KODATEF® (tafenoquine) from Australia as a one-time, preemptive measure against any near-term disruption in the U.S. supply of ARAKODA® (tafenoquine).
ARAKODA is an antimalarial indicated for the prophylaxis of malaria in patients aged 18 years and older in the United States (U.S.) It is sold under the brand name KODATEF in Australia, where it is indicated for the prevention of malaria in adults 18 years of age and above. The two products are identical in their dosing regimens, mechanisms of action, safety and efficacy profiles, and other clinical features. KODATEF is not approved for use in the U.S.
Demand for ARAKODA has been steadily growing in recent months as awareness and use of the product has expanded across the U.S. The Company is taking the proactive step of importing KODATEF as a demonstration of its long-standing commitment to ensuring that tafenoquine for malaria prophylaxis remains readily available to healthcare providers at all times.
The Company plans to import a five-month supply of KODATEF while increasing manufacturing output of ARAKODA over the long-term.
A notice about this information is expected to be posted by FDA on its website.
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, offers the advantage of less frequent dosing for the prophylaxis of 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.
60 Degrees Pharma Announces IRB Approval of Phase II Study to Evaluate Tafenoquine for Chronic Babesiosis
- Investigational Review Board (IRB) approval has been granted for the open-label study to evaluate tafenoquine for treatment of patients with a presumptive diagnosis of chronic babesiosis in outpatient settings.
- Enrollment expected to commence Q3 2025.
WASHINGTON, Jan. 28, 2025 (GLOBE NEWSWIRE) — 60 Degrees Pharmaceuticals, Inc. (NASDAQ: SXTP; SXTPW) (the “Company”), a pharmaceutical company focused on developing new medicines for infectious diseases, announced today the approval of an Investigational Review Board (IRB) sanctioned Phase II clinical study.
The study (NCT06656351) will evaluate the efficacy and safety of the ARAKODA® regimen (tafenoquine) over 90 days for treating patients with a presumptive diagnosis of chronic babesiosis. Participants will have experienced significant functional impairment for at least six months. Patient enrollment is expected to begin in Q3 2025.
“As babesiosis continues to emerge in new regions of the U.S., the need to address its impact safely and effectively is also growing,” said 60 Degrees Pharmaceuticals, Inc. Chief Executive Officer, Geoff Dow, PhD. “The chronic phase of babesiosis particularly may prove to be one of the most important areas of study due to the estimated large size of the patient population, the severity and duration of symptoms, and the absence of any approved treatment option available today.”
The Company estimates the total cumulative addressable market through the end of U.S. patent protection in December 2035 for ARAKODA (tafenoquine) for babesiosis exceeds 400,000 patients.
About Babesiosis
Babesiosis is a tick-borne illness caused by Babesia parasites that develop and multiply in red blood cells. Its symptoms include fevers, chills, sweats, and fatigue, and in severe cases, can be life-threatening threatening in elderly and immunosuppressed patients. Incidence of the disease is rapidly rising, particularly in the Northeast. Transmitted through the bite of the black-legged (deer) tick, the vector that spreads Lyme disease, babesiosis is an orphan disease. Babesia infection may persist for at least a year; fatigue is usually the symptom of infection that takes longest to resolve and may be debilitating over the long term in some patients.
NEWS
60 Degrees Pharmaceuticals Announces 2024 Annual Results
Mar 28, 2025
Feb 21, 2025
60 Degrees Pharmaceuticals, Inc. Announces 1:5 Reverse Stock Split
Feb 20, 2025
Feb 11, 2025
Feb 5, 2025
RedChip Launches RedChat: Revolutionary AI Chatbot for Small-Cap Stock Analysis
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Dec 11, 2024
Dec 2, 2024
Nov 22, 2024
60 Degrees Pharmaceuticals Announces Third Quarter 2024 Results
Nov 14, 2024
Oct 3, 2024
Sep 4, 2024
60 Degrees Pharmaceuticals, Inc. Regains Compliance with Nasdaq Listing Requirements
Aug 28, 2024
60 Degrees Pharmaceuticals Announces Second Quarter 2024 Results
Aug 14, 2024
Aug 12, 2024
60 Degrees Pharmaceuticals, Inc. Announces 1:12 Reverse Stock Split
Aug 6, 2024
MANAGEMENT TEAM
Geoffrey Dow
Chief Executive Officer & President
Geoffrey Dow is the CEO, President, and a Director of 60 Degrees Pharmaceuticals, Inc. (60P). He has over 20 years of experience in product development for tropical diseases and a strong publication and patent history. He has 13 years of leadership and advisory experience in the antimalarial drug development program at the Walter Reed Army Institute of Research and the U.S. Army Medical Materiel Development Activity. Dr. Dow co-founded 60P in 2010 and has been instrumental in various projects including securing FDA-regulatory approval for tafenoquine (Arakoda) for malaria prophylaxis, managing post-marketing regulatory commitments, and ensuring the company adheres to GMP, quality, and pharmacovigilance requirements. He has also published several important safety reviews, clinical trials, and non-clinical studies. Dr. Dow’s ultimate goal is to develop and secure regulatory approval and commercial success of products for new indications in infectious disease. He holds a B.Sc. (Hons) in Veterinary and Biomedical Science from Murdoch University, Perth, Western Australia (1994), a Ph.D. in Veterinary and Biomedical Science from Murdoch University (2000), and an MBA from the University of Maryland at College Park (2012).
Bryan Smith
Chief Medical Officer
Bryan Smith is the Chief Medical Officer of 60 Degrees Pharmaceuticals, Inc. (60P). He is a medical doctor with expertise in clinical pharmacology, pharmacovigilance, regulatory strategy development, and translational medicine. He has over 30 years of experience in governmental research and leadership and is a retired military colonel. He joined the company in 2016 and works with the senior management team to establish all functional areas, including compliance with laws and regulations and overseeing research and development projects. Dr. Smith is also a Senior Medical Director, Clinical and Regulatory Affairs at Fast-Track Drugs & Biologics, LLC since 2019, where he is responsible for developing clinical development plans, managing clinical and regulatory projects, and designing and writing clinical trial protocols. He has also served as the Chief Medical Officer and member of Amivas LLC, where he established all functional areas required to secure FDA approvals. Additionally, from 2016 to 2019, he was the Principal Medical Consultant at Clinical Network Services, Inc. where he provided medical, clinical pharmacology, regulatory, and translational medicine review, oversight and consultation as requested for over 25 unique clients in a range of activities and tasks for devices, small molecules, and large molecules in a range of therapeutic areas. He holds a Bachelor of Science in General Science, with highest honors, from Oregon State University and a Doctor of Medicine from Uniformed Services University of the Health Sciences.
Tyrone Miller
Treasurer
Tyrone Miller is the Treasurer of 60 Degrees Pharmaceuticals, Inc. (60P). He joined the company in 2014 and has held various roles including Chief Financial Officer. He has experience raising over $6 million in external financing and established a multinational financial reporting system. He provides strategic advice in areas of financing and business planning to the company. He is also the founder and Principal of Tax & Accounting Practice at Miller Tax & Advisory since 2011, where he advises business owners on accounting, financial, and tax matters and has designed accounting systems for private businesses. Prior to that, he was a Senior Accountant at Sachs Figurelli, LLC from 2002 to 2011 where he prepared and processed corporate and individual tax returns, consulted on accounting processes for various businesses, and managed staff in preparation and processing of payroll and personal property returns. He is a Certified Public Accountant and received a Bachelor’s of Business Administration with a concentration in International Business from Emory University in 1996.
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