OUR NEW PROFILE IS: (NASDAQ: SXTP)
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SXTP HAS JUST 5 MILLION SHARES IN THE FLOAT ACCORDING TO FINVIZ
SXTP PIVOTS TO REFOCUS ON COMMERCIALIZATION OF TREATMENTS FOR MALARIA AND TICK-BORNE DISEASES
READ THE INVESTOR PRESENTATION HERE
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Hello Everyone,
I hope that you are paying attention.
We sent out our last profile at 2 pm Monday when the company was sitting right under 1.10. During Tuesdays session it ran all the way up to 1.43 on above average interest after releasing news. This was another overnight double digit run.
Moving on………………
We have a brand new company that we want you to take a look at. This is a company that just IPO’d right before the summer and is sitting at a significant discount from it’s initial levels.
This one has a tiny float and a market cap just over $3Mill right now.
We have recently seen what happens when these low float plays pick up momentum.
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 our 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.
Our current product development targets include tick- borne, viral, fungal and other serious infectious diseases with unmet needs we perceive in the marketplace.
PORTFOLIO
Investment Highlights
▪ ARAKODA – a long-acting, potentially broad-spectrum, anti-infective already FDA-approved for malaria prevention and commercially available in the U.S.
▪ Safe, long acting, mechanistically differentiated antimalarial approved by FDA
▪ Discovered by US Army and successfully brought to market by 60P
▪ 1,100+ patient exposures in 8+ published clinical trials, weekly dosing for up to one year
▪ Commercially available in U.S. via network of major national distributors
▪ Existing commercial/regulatory infrastructure expected to facilitate cost-effective pathway to new/expanded indications following targeted clinical trial and label changes
▪ Arakoda Regimen of Tafenoquine – Research agenda involving babesiosis and other diseases
▪ Malaria, COVID-19, fungal, tick-borne illness of interest to the Company affect millions and are associated with a potentially high revenue unmet medical need ▪ Company has strong IP for malaria, COVID-19, and other indications
▪ Accelerated clinical recovery from babesiosis is suggested by case studies of immunosuppressed patients administered tafenoquine
▪ 2024: Execute Phase IIA treatment study in hospitalized babesiosis patients
▪ 2025: sNDA and/or confirmatory babesiosis patient study
▪ Experienced management team and Board
▪ Team has together led/managed four clinical trials
▪ Collectively led multiple pharmaceutical product approvals/product launches ▪ Collectively led/provided guidance on 20+ public & private entities
▪ Participated in/led multiple public listings
Intellectual Property & Licensing
60 Degrees Pharmaceuticals has freedom to operate
- U.S. Arakoda Patents (2 issued/6 in progress)
- T afenoquine for malaria prevention patent family: Earliest expiration December 2034
- Tafenoquine for lung Infections/COVID Treatment: Earliest expiration March 2041
- U.S. Celgosivir Patents
- Dengue/RSV (4 issued/2 in progress)
- International Patents
■ 6/2 for Celgosivir issued/in progress, 1/8 for tafenoquine issued/in progress
■ Clinical, non-clinical and manufacturing information
60 DEGREES PHARMACEUTICALS SUSPENDS PHASE IIB STUDY OF TAFENOQUINE FOR COVID-19, PIVOTS TO REFOCUS ON COMMERCIALIZATION OF TREATMENTS FOR MALARIA AND TICK-BORNE DISEASES
October 12, 2023 at 4:16 PM EDT
- FDA advice to Company suggested execution of ACLR8-LR, a placebo-controlled Phase IIB study of tafenoquine in COVID-19 patients, may not be feasible in the U.S.
- Company will therefore focus efforts on further commercialization related to ARAKODA® (tafenoquine) for prophylaxis of malaria, and prepare for a Phase IIA study of tafenoquine in hospitalized babesiosis patients
- Company is preparing for submission of a pre-IND meeting request with FDA for babesiosis in the current fourth quarter of 2023, and plans to appoint a chief commercial officer to lead ARAKODA commercialization
WASHINGTON, Oct. 12, 2023 (GLOBE NEWSWIRE) — 60 Degrees Pharmaceuticals, Inc. (NASDAQ: SXTP; SXTPW) (“60P” or the “Company”), a pharmaceutical company focused on developing new medicines for infectious diseases, announced that its subsidiary, 60P Australia Pty Ltd, will not re-submit its investigational new drug application (“IND”) for ACLR8-LR, a Phase IIB study of tafenoquine compared to placebo in patients with mild to moderate COVID-19 disease and low risk of disease progression. Tafenoquine is the active molecule in ARAKODA®, the Company’s U.S. Food and Drug Administration (FDA)-approved regimen for malaria prevention. The Company’s Board of Directors decided on October 6, 2023, that recent advice from the FDA made moving forward with the ACLR8-LR clinical development plan unfeasible.
The FDA has approved or authorized two marketed oral products, Lagrevio™ and Paxlovid™, for use in cases of mild-to-moderate COVID-19 disease to reduce the rate of hospitalizations and deaths in patients with high risk of disease progression. However, the FDA has explicitly not authorized the use of those products in patients with low risk of COVID-19 disease progression. Accordingly, Lagrevio and Paxlovid are not recommended by public health agencies for that purpose.
Current literature on COVID-19 shows that low risk patients have a very low risk of hospitalization. However, patients may wish to make a risk-based decision together with their physician to use a therapeutic that accelerates clinical recovery from COVID-19 symptoms if such a therapeutic were available. FDA guidance for industry implies that a regulatory pathway does exist for approval of new therapeutics that produce “sustained clinical recovery” in COVID-19 patients. FDA-approved or authorized oral therapies have either failed or have not been studied against that endpoint.
60P’s early, published Phase IIA clinical data suggested the possibility of a 2 – 2.5 day improvement in clinical recovery from cough, fever, and shortness of breath.1 Simulations of data from the same study suggested this might also be the case for the FDA’s preferred endpoint of “sustained clinical recovery” from all acute symptoms excluding impaired taste and smell (see accompanying figure).
However, in a recent IND withdrawal acknowledgement letter from the FDA, the agency implied that a placebo-controlled study in the U.S. is permissible only if study enrollment is “restricted to a patient population in which nirmatrelvir/ritonavir or other approved or authorized therapeutics are not clinically appropriate.”
As a practical matter, the population of patients in the U.S. with medical contraindications to Paxlovid™ and Lagevrio™ is vanishingly small, which would make patient recruitment very challenging. The Company also considered the FDA’s recommended approach of a standard of care add-on design. However, such a combination approach may not make clinical sense in a low-risk population or be Phase III enabling. In either case, the Company’s Board of Directors determined that raising capital to support a protracted development campaign, or one requiring three additional studies, was not feasible in the current market environment.
Accordingly, as outlined in its registration statement and subsequent communications to the investment community, 60P will instead continue to prepare to conduct a Phase IIA study of tafenoquine in hospitalized babesiosis patients, with the goal of requesting a pre-IND meeting with FDA before the end of 2023.
An estimated 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 percent of Lyme disease patients are co-infected with babesiosis. Post-exposure prophylaxis following a tick bite is a recognized indication to prevent Lyme disease, and it is likely that a drug proven to be effective for this indication for babesiosis would also be used in conjunction with Lyme prophylaxis.
60P also intends to hire a commercial operations executive to expand 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 the second quarter of 2023, sales of ARAKODA increased by 150 percent relative to the same period in 2022, at an accelerating growth rate.
NEWS
PUBLISHED
OCT 19, 2023
60 DEGREES PHARMA TO PRESENT REVIEW OF SAFETY, EFFICACY DATA OF 8-AMINOQUINOLINES FOR MALARIA AND BABESIOSIS TREATMENT AT ILADS ANNUAL SCIENTIFIC MEETING IN BOSTON
PUBLISHED
OCT 12, 2023
60 DEGREES PHARMACEUTICALS SUSPENDS PHASE IIB STUDY OF TAFENOQUINE FOR COVID-19, PIVOTS TO REFOCUS ON COMMERCIALIZATION OF TREATMENTS FOR MALARIA AND TICK-BORNE DISEASES
PUBLISHED
SEP 18, 2023
60 DEGREES PHARMA WITHDRAWS COVID PHASE IIB IND, WILL RESUBMIT PENDING ASSESSMENT OF ABILITY TO MEET FDA REQUIREMENTS
PUBLISHED
SEP 6, 2023
60 DEGREES PHARMACEUTICALS TO PARTICIPATE IN H.C. WAINWRIGHT 25TH ANNUAL GLOBAL INVESTMENT CONFERENCE
PUBLISHED
SEP 1, 2023
GENETIC TECHNOLOGIES LIMITED AND 60 DEGREES PHARMACEUTICALS INTERVIEWS TO AIR ON THE REDCHIP MONEY REPORT(R) ON BLOOMBERG TV
PUBLISHED
AUG 30, 2023
60 DEGREES PHARMACEUTICALS STUDY RESULTS PUBLISHED BY NEW MICROBES AND NEW INFECTIONS DEMONSTRATE TAFENOQUINE EXHIBITS BROAD SPECTRUM ANTIFUNGAL ACTIVITY
PUBLISHED
AUG 22, 2023
60 DEGREES PHARMACEUTICALS RECEIVES ADDITIONAL U.S. PATENT COVERING TAFENOQUINE FOR PREVENTION OF PLASMODIUM FALCIPARUM MALARIA
PUBLISHED
AUG 15, 2023
60 DEGREES PHARMACEUTICALS REGISTERS ACLR8-LR, A PHASE IIB STUDY OF TAFENOQUINE FOR TREATMENT OF COVID-19, ON CLINICALTRIALS.GOV
PUBLISHED
JUL 31, 2023
60 DEGREES PHARMACEUTICALS AWARDED CANADIAN PATENT COVERING TAFENOQUINE FOR PREVENTION OF MALARIA IN MALARIA-NAIVE SUBJECTS
PUBLISHED
JUL 21, 2023
60 DEGREES PHARMACEUTICALS AND UNICYCIVE THERAPEUTICS INTERVIEWS TO AIR ON BLOOMBERG TV ON THE REDCHIP MONEY REPORT(R)
PUBLISHED
JUL 14, 2023
WALLACHBETH CAPITAL ANNOUNCE CLOSING OF 60 DEGREES PHARMACEUTICALS IPO AT $5.30 PER UNIT
PUBLISHED
JUL 14, 2023
60 DEGREES PHARMACEUTICALS ANNOUNCES CLOSING OF INITIAL PUBLIC OFFERING
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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