60 Degrees Pharmaceuticals Inc
$1.08 +0.0050 +0.47% 114.9K
Developing therapeutic innovations that can significantly improve and extend people’s lives
Analyst Report
Q2 FY24 impacted by non-cash charge. Babesiosis trial on track, with timeline somewhat extended. Re-setting PT to $5.50.
Company Overview
60 Degrees Pharmaceuticals (60P) is a growth-oriented biotechnology company with a goal of using cutting-edge biological science and applied research to further develop and commercialize new therapies for the prevention and treatment of infectious diseases. 60P has successfully achieved regulatory approval of ARAKODA® (tafenoquine), a malaria preventative treatment that has been on the market since late 2019. Currently, 60P’s pipeline includes development programs for Tafenoquine and Celgosivir targeting fungal, tick-borne, and other viral diseases.
Value Proposition
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 pivotal study of tafenoquine in hospitalized babesiosis patients. 60P anticipates initiating patient enrollment for this trial in mid-2024. 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.
Anticipated Future Milestones
(Pivotal Babesiosis Study)
Other Anticipated Milestones:
- Detailed TAM Estimates for tick-borne diseases
- Hiring of Chief Commercial Officer
- Trade & Scientific Conferences
- New product development collaborations
Investor Presentation
Investment Highlights
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ARAKODA® (tafenoquine) – Overview
- FDA-approved safe, long-acting, mechanistically differentiated anti-malarial
- Discovered by and co-developed with U.S. Army
- 1,100+ patient exposures in 8+ published trials
- 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 trials and label changes
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ARAKODA Regimen of Tafenoquine - Research & Development Agenda
- Company has strong IP for malaria and other indications
- Preparing to launch a pivotal study of tafenoquine in hospitalized babesiosis patients in mid-2024
- 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 US each year, and the incidence rate is increasing
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60 Degrees Pharmaceuticals – Overview
- Seasoned Management Team and Board
- Profound clinical expertise in tafenoquine and related therapeutics
- Team has together led/managed four clinical trials
- Collectively led multiple pharmaceutical product approvals/ international pharmaceutical product launches
- Collectively led/provided guidance to multiple public & private entities
- Participated in/led multiple public listings
- Buy rating from Ascendiant Capital Markets
About Babesiosis
- Tick-borne disease caused by protozoan parasites of the genus Babesia
- Invades red blood cells, causing:
- Non-specific flu-like symptoms
- Anemia
- Death (1.6% mortality rate in hospitalized patients/10% in those with cardiac complications)
- May be refractory to treatment in immunosuppressed patients
- Associated with chronic post-treatment syndrome
- Common in Mid-West and Northeastern US
- Geographic range expanding and incidence increasing
- Common coinfection with Lyme disease (10% of cases)
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