(Nasdaq:SXTP) Profile

Sixty Degrees Pharmaceuticals

OUR NEW PROFILE IS:   (NASDAQ: SXTP)

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SXTP HAS LESS THAN 4 MILLION SHARES IN THE FLOAT ACCORDING TO FINVIZ

SXTP PIVOTS TO REFOCUS ON COMMERCIALIZATION OF TREATMENTS FOR MALARIA AND TICK-BORNE DISEASES

60 DEGREES PHARMA PLANS PIVOTAL BABESIOSIS STUDY WITH TAFENOQUINE FOLLOWING JAN 17 FDA MEETING

READ THE INVESTOR PRESENTATION HERE

Hello Everyone,

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 under $4Mill right now.

We have recently seen what happens when these low float plays pick up momentum.

Pull up SXTP.

This one started moving today after they dropped significant news before the bell which you can read below.

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.

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 DEGREES PHARMA PLANS PIVOTAL BABESIOSIS STUDY WITH TAFENOQUINE FOLLOWING JAN 17 FDA MEETINGFollowing a Type C meeting with FDA on January 17, 2024, 60 Degrees Pharma (60P) now plans to conduct a pivotal clinical study in support of a future indication for tafenoquine for treatment of hospitalized babesiosis patientsPatient enrollment to begin in summer of 2024WASHINGTON, Jan. 22, 2024 (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 today that, following a Type C meeting held on January 17, 2024with the US Food and Drug Administration (FDA), the Company will move forward with a pivotal clinical study of tafenoquine in hospitalized babesiosis patients in the U.S.

In advance of the meeting, 60P provided to the FDA an information package that included a presentation of the unmet medical need for a new therapeutic for hospitalized babesiosis patients. It also included a detailed outline of the proposed study protocol. The FDA indicated in remarks during the meeting that the proposed study could be sufficient for regulatory approval, provided the Company uses a clinical endpoint rather than a surrogate marker. 60P is now revising the study protocol in light of that feedback, with the goal of initiating patient enrollment in the summer of 2024.

“Our recent Type C meeting with the FDA led to mutual alignment with respect to the design of a development plan to evaluate the ARAKODA® regimen of tafenoquine for treating people who are hospitalized with babesiosis,” said Geoff Dow, Chief Executive Officer of 60 Degrees Pharmaceuticals. “We are excited to advance this important study, as tick-borne illnesses such as babesiosis are emerging rapidly in the U.S. and can be life-threatening. Our aim is to bring a new treatment option to healthcare providers seeking a safe, effective solution to address the needs of their hospitalized patients diagnosed with this very serious condition.”

Total babesiosis patients in the U.S. may be approximately 47,000 per year based on the observation of 476,000 Lyme infections and an estimated babesiosis co-infection rate of 10 percent.

Tafenoquine is approved for malaria prophylaxis in patients aged 18 years and older 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 FDA for such an indication.

About the Tafenoquine for Babesiosis StudyThe study, titled, “Double-blind Placebo-controlled Study to Assess the Safety and Efficacy of Oral Tafenoquine plus Standard of Care versus Placebo plus Standard of Care in Patients Hospitalized for Babesiosis,” is anticipated to enroll patients in the U.S.beginning in the summer of 2024. The study will be conducted at three hospitals in the northeastern United States.

The appearance of several case studies of tafenoquine use for babesiosis in the literature suggests that the drug is being used for this purpose in the practice of medicine in the U.S.

About BabesiosisAn estimated 47,000 cases of babesiosis (i.e., 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 steadily increasing. An estimated 10 percent of Lyme disease patients are co-infected with babesiosis. The mortality rate of babesiosis patients who have cardiac complications approaches 10 percent.

Babesiosis is spread by the bite of an infected blacklegged tick, Ixodes scapularis. It can also be spread by transfusion of contaminated blood.

Anyone can get babesiosis, but it can be more severe in the elderly, people who have had their spleen removed, and in people who have weakened immune systems (for example, those who have cancer, HIV/AIDS or a transplant). Most cases occur in coastal areas in the Northeast and upper Midwest, particularly in parts of New England, New York State, New Jersey, Wisconsin, Minnesota and in some European countries. In the Northeast, babesiosis occurs in both inland and coastal areas, including offshore islands such as Nantucket and Martha’s Vineyard, which are off Massachusetts, as well as in Long Island and the Hudson Valley in New York State.

Hospitalizations as a result of babesiosis are usually seasonal, occurring June through August. Clinical complications include severe anemia, renal failure, cardiorespiratory failure and death. Babesiosis was designated a nationally notifiable disease in the United States in 2011, meaning that states where it was reportable were charged to voluntarily notify the Centers for Disease Control and Prevention(CDC) of cases. As of 2019, babesiosis was reportable in 40 states and the District of Columbia.

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.

ARAKODAFULFILLING THE PROMISE OF ARAKODABy 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 TREATMENTThe 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 BABESIOSISTafenoquine 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 PHARMA ANNOUNCES IRB APPROVAL OF PHASE IIA STUDY TO EVALUATE TAFENOQUINE FOR BABESIOSIS, AN EMERGING TICK-BORNE DISEASE; TYPE C MEETING RE-SCHEDULED BY FDA TO JANUARY 17, 2024

  • Investigational Review Board (IRB) approval has been granted for 60 Degrees Pharma’s double-blind, placebo-controlled study to investigate tafenoquine for treatment of hospitalized babesiosis patients
  • The previously announced Type C meeting with FDA has been rescheduled by FDA from January 15 to January 17, 2024, due to a federal holiday

WASHINGTON, Dec. 26, 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 today the approval of an Investigational Review Board (IRB) sanctioned Phase IIA clinical study. The study aims to investigate the efficacy and safety of the ARAKODA® regimen of tafenoquine in combination with standard of care medications for treatment of hospitalized babesiosis patients at lower risk of relapse.

Additionally, the U.S. Food and Drug Administration (FDA) rescheduled the Company’s previously announced January 15 Type C meeting to January 17, 2024, due to a federal holiday. The agenda and all material submitted by SXTP to FDA in support of the Type C meeting remain unchanged.

Babesiosis is a potentially life-threatening, tick-borne illness steadily emerging in the United States. Total babesiosis patients in the U.S. may be approximately 47,000 per year based on the observation of 476,000 Lyme infections and an estimated babesiosis coinfection rate of 10 percent.

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 FDA for such an indication.

About the Phase IIA Tafenoquine for Babesiosis StudyThe Phase IIA study, titled, “Double-blind Placebo-controlled Study to Assess the Safety and Efficacy of Oral Tafenoquine plus Standard of Care versus Placebo plus Standard of Care in Patients Hospitalized for Babesiosis,” is anticipated to enroll at least 24 patients in the U.S., beginning in Q2 2024. The primary endpoint of the study will be time to molecular cure as determined by an FDA-approved nucleic acid test (NAT). The study will be conducted at three hospitals in the northeastern United States.

The efficacy and safety of 8-aminoquinolines, a class of drugs that includes tafenoquine and primaquine, for prevention and treatment of malaria is well established. The appearance of several case studies of tafenoquine use for babesiosis in the literature suggests that the drug is being used for this purpose in the practice of medicine in the U.S.

About BabesiosisAn estimated 47,000 cases of babesiosis (i.e., 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 steadily increasing. An estimated 10 percent of Lyme disease patients are co-infected with babesiosis. The mortality rate of babesiosis patients who have cardiac complications approaches 10 percent.

Babesiosis is spread by the bite of an infected blacklegged tick, Ixodes scapularis. It can also be spread by transfusion of contaminated blood.

Anyone can get babesiosis, but it can be more severe in the elderly, people who have had their spleen removed, and in people who have weakened immune systems (for example, those who have cancer, HIV/AIDS, or a transplant). Most cases occur in coastal areas in the Northeast and upper Midwest, particularly in parts of New England, New York State, New Jersey, Wisconsin, Minnesota and in some European countries. In the Northeast, babesiosis occurs in both inland and coastal areas, including offshore islands such as Nantucket and Martha’s Vineyard, which are off Massachusetts, as well as in Long Island and the Hudson Valley in New York State.

Hospitalizations as a result of babesiosis are usually seasonal, occurring June through August. Clinical complications include severe anemia, renal failure, cardiorespiratory failure, and death. Babesiosis was designated a nationally notifiable disease in the United States in 2011, meaning that states where it was reportable were charged to voluntarily notify the Centers for Disease Control and Prevention (CDC) of cases. As of 2015, babesiosis was reportable in 33 states.

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

9 HOURS AGO

60 DEGREES PHARMA PLANS PIVOTAL BABESIOSIS STUDY WITH TAFENOQUINE FOLLOWING JAN 17 FDA MEETING

PUBLISHED

6 DAYS AGO

60 DEGREES PHARMA REGAINS COMPLIANCE WITH NASDAQ LISTING REQUIREMENTS

PUBLISHED

DEC 26, 2023

60 DEGREES PHARMA ANNOUNCES IRB APPROVAL OF PHASE IIA STUDY TO EVALUATE TAFENOQUINE FOR BABESIOSIS, AN EMERGING TICK-BORNE DISEASE; TYPE C MEETING RE-SCHEDULED BY FDA TO JANUARY 17, 2024

PUBLISHED

NOV 15, 2023

60 DEGREES PHARMA ANNOUNCES TYPE C MEETING WITH FDA TO DISCUSS DEVELOPMENT OF TAFENOQUINE FOR BABESIOSIS, AN EMERGING TICK-BORNE DISEASE

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.

SINCERELY,