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What changed in 60 DEGREES PHARMACEUTICALS, INC.'s 10-K — 2024 vs 2025

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Paragraph-level year-over-year comparison of 60 DEGREES PHARMACEUTICALS, INC.'s 2024 and 2025 10-K annual filings, covering the Business, Risk Factors, Legal Proceedings, Cybersecurity, MD&A and Market Risk sections. Every new, removed and edited paragraph is highlighted side-by-side so you can see exactly what management changed in the 2025 report.

+235 added−211 removedSource: 10-K (2026-03-30) vs 10-K (2025-03-27)

Top changes in 60 DEGREES PHARMACEUTICALS, INC.'s 2025 10-K

235 paragraphs added · 211 removed · 162 edited across 4 sections

Item 1. Business

Business — how the company describes what it does

155 edited+71 added−48 removed279 unchanged
Biggest changeEstimated/ Anticipated Expiration Date Treatment Of Human Coronavirus Infections Using Alpha-Glucosidase Glycoprotein Processing Inhibitors 11369592 US 6/28/2022 17/180,140 # 19-Feb-2041 ^ Treatment Of Human Coronavirus Infections Using Alpha-Glucosidase Glycoprotein Processing Inhibitors Pending US Pending 17/664,693 # 19-Feb-2041 ^ Treatment Of Human Coronavirus Infections Using Alpha-Glucosidase Glycoprotein Processing Inhibitors Pending EP Pending 2021757552 # 19-Feb-2041* Methods For The Treatment And Prevention Of Non-Viral Tick-Borne Diseases And Symptoms Thereof Provisional US Provisional 63/461,060 ~21-Apr-2044 & Methods To Treat Respiratory Infection Utilizing Castanospermine Analogs Pending US Pending 18/218,202 05-Jul-2043 ^ Methods To Treat Respiratory Infection Utilizing Castanospermine Analogs Pending PCT Pending PCT/US23/26884 05-Jul-2043* Methods For The Treatment And Prevention Of Diseases Or Infections With MCP-1 Involvement By Administration Of Tafenoquine Pending US Pending 18/375,070 30-Sep-2043 ^ Methods For The Treatment And Prevention Of Diseases Or Infections With MCP-1 Involvement By Administration Of Tafenoquine Pending PCT Pending PCT/US23/34169 30-Sep-2043 Treatment Of Zika Virus Infections Using Alpha Glucosidase Inhibitors 10,328,061 + US 6-25-2019 15/584,952 + 2-May-37 Treatment Of Zika Virus Infections Using Alpha Glucosidase Inhibitors 10,561,642 + US 2-18-2020 15/856,377 + 2-May-37 * = For foreign patents and applications, the estimated and/or anticipated patent expiration is the date that is twenty years from the PCT filing date.
Biggest changeEstimated/ Anticipated Expiration Date Treatment Of Human Coronavirus Infections Using Alpha-Glucosidase Glycoprotein Processing Inhibitors 11369592 US 6/28/2022 17/180,140# 19-Feb-2041** Treatment Of Human Coronavirus Infections Using Alpha-Glucosidase Glycoprotein Processing Inhibitors Pending US Pending 17/664,693# 19-Feb-2041** Treatment Of Human Coronavirus Infections Using Alpha-Glucosidase Glycoprotein Processing Inhibitors Pending EP Pending 2021757552 # 19-Feb-2041* Methods To Treat Respiratory Infection Utilizing Castanospermine Analogs Pending Australia Pending 2023304186 05-Jul-2043* Methods To Treat Respiratory Infection Utilizing Castanospermine Analogs 12,569,473 US 3/10/2026 18/218,202 05-Jul-2043** Methods To Treat Respiratory Infection Utilizing Castanospermine Analogs Pending China Pending 202380053343.1 05-Jul-2043* Methods To Treat Respiratory Infection Utilizing Castanospermine Analogs Pending EP Pending 23836044.4 05-Jul-2043* Methods To Treat Respiratory Infection Utilizing Castanospermine Analogs Pending Canada Pending 3261048 05-Jul-2043* Methods For The Treatment And Prevention Of Diseases Or Infections With MCP-1 Involvement By Administration Of Tafenoquine Pending US Pending 18/375,070 30-Sep-2043** Methods For The Treatment And Prevention of Non-Viral Tick-Borne Diseases And Symptoms Thereof Pending US Pending 18/640,611 19-Apr-2044** Methods For The Treatment And Prevention of Non-Viral Tick-Borne Diseases And Symptoms Thereof Pending Canada Pending 3289679 19-Apr-2044* Methods For The Treatment And Prevention of Non-Viral Tick-Borne Diseases And Symptoms Thereof Pending China Pending 202480041674.8 19-Apr-2044* Methods For The Treatment And Prevention of Non-Viral Tick-Borne Diseases And Symptoms Thereof Pending EP Pending 24793579.4 19-Apr-2044* Methods For The Treatment And Prevention of Non-Viral Tick-Borne Diseases And Symptoms Thereof Pending Japan Pending 2025-561977 19-Apr-2044* Methods For The Treatment And Prevention of Non-Viral Tick-Borne Diseases And Symptoms Thereof Pending US Pending 18/640,657 19-Apr-2044** Methods For The Treatment And Prevention of Non-Viral Tick-Borne Diseases And Symptoms Thereof Pending Canada Pending 3289735 19-Apr-2044* 16 Title Patent No.
However, any holder may increase or decrease such percentage, provided that any increase will not be effective until the 61st day after such election.
However, any holder may increase or decrease such percentage, provided that any increase will not be effective until the 61st day after such election.
Whether or not it obtains FDA approval for a product, the company would need to obtain the necessary approvals by the comparable foreign regulatory authorities before it can commence clinical trials or marketing of the product in those countries or jurisdictions.
Whether or not it obtains FDA approval for a product, the company would need to obtain the necessary approvals by the comparable foreign regulatory authorities before it can commence clinical trials or marketing of the product in those countries or jurisdictions.
The approval process ultimately varies between countries and jurisdictions and can involve additional product testing and additional administrative review periods. The time required to obtain approval in other countries and jurisdictions might differ from and be longer than that required to obtain FDA approval.
The approval process ultimately varies between countries and jurisdictions and can involve additional product testing and additional administrative review periods. The time required to obtain approval in other countries and jurisdictions might differ from and be longer than that required to obtain FDA approval.
Among the provisions of the ACA of importance to our potential product candidates are: ● an annual, non-deductible fee on any entity that manufactures or imports specified branded prescription drugs and biologic agents, apportioned among these entities according to their market share in certain government healthcare programs; ● expansion of eligibility criteria for Medicaid programs by, among other things, allowing states to offer Medicaid coverage to certain individuals with income at or below 133% of the federal poverty level, thereby potentially increasing a manufacturer’s Medicaid rebate liability; 37 ● expanded manufacturers’ rebate liability under the Medicaid Drug Rebate Program by increasing the minimum rebate for both branded and generic drugs and revising the definition of “average manufacturer price,” or AMP, for calculating and reporting Medicaid drug rebates on outpatient prescription drug prices; ● addressed a new methodology by which rebates owed by manufacturers under the Medicaid Drug Rebate Program are calculated for drugs that are inhaled, infused, instilled, implanted or injected; ● expanded the types of entities eligible for the 340B drug discount program; ● established the Medicare Part D coverage gap discount program by requiring manufacturers to provide a 50% point-of-sale-discount off the negotiated price of applicable brand drugs to eligible beneficiaries during their coverage gap period as a condition for the manufacturers’ outpatient drugs to be covered under Medicare Part D; and ● a new Patient-Centered Outcomes Research Institute to oversee, identify priorities in, and conduct comparative clinical effectiveness research, along with funding for such research.
Among the provisions of the ACA of importance to our potential product candidates are: an annual, non-deductible fee on any entity that manufactures or imports specified branded prescription drugs and biologic agents, apportioned among these entities according to their market share in certain government healthcare programs; expansion of eligibility criteria for Medicaid programs by, among other things, allowing states to offer Medicaid coverage to certain individuals with income at or below 133% of the federal poverty level, thereby potentially increasing a manufacturer’s Medicaid rebate liability; expanded manufacturers’ rebate liability under the Medicaid Drug Rebate Program by increasing the minimum rebate for both branded and generic drugs and revising the definition of “average manufacturer price,” or AMP, for calculating and reporting Medicaid drug rebates on outpatient prescription drug prices; addressed a new methodology by which rebates owed by manufacturers under the Medicaid Drug Rebate Program are calculated for drugs that are inhaled, infused, instilled, implanted or injected; expanded the types of entities eligible for the 340B drug discount program; established the Medicare Part D coverage gap discount program by requiring manufacturers to provide a 50% point-of-sale-discount off the negotiated price of applicable brand drugs to eligible beneficiaries during their coverage gap period as a condition for the manufacturers’ outpatient drugs to be covered under Medicare Part D; and a new Patient-Centered Outcomes Research Institute to oversee, identify priorities in, and conduct comparative clinical effectiveness research, along with funding for such research.
All estimated patent expiration dates and anticipated patent expiration assume payment of any maintenance/annuity fees during the patent term. 15 Trademarks Country Mark Status Application Number Date Filed Registration Date Registration Number BIR Ref Number Due Date Due Date Description Australia KODATEF Registered 1774631 2-Jun-16 6/2/2016 1774631 0081716-000029 2-Jun-26 Renewal Due Canada KODATEF Registered 1785098 1-Jun-16 11/26/2019 TMA1,064,371 0081716-000028 26-Nov-29 Renewal Due Canada ARAKODA Registered 1899317 15-May-18 8/20/2020 TMA1,081,180 0081716-000053 20-Aug-30 Renewal Due China KODATEF Registered 20842242 2-Aug-16 9/28/2017 20842242 0081716-000035 27-Sep-27 Renewal Due European Union KODATEF Registered 15508872 3-Jun-16 9/21/2016 15508872 0081716-000034 3-Jun-26 Renewal Due European Union ARAKODA Registered 17900852 16-May-18 9/20/2018 17900852 0081716-000054 16-May-28 Renewal Due Israel KODATEF Registered 285476 6-Jun-16 6/6/2016 285476 0081716-000033 6-Jun-26 Renewal Due New Zealand KODATEF Registered 1044407 7-Jun-16 12/8/2016 1044407 0081716-000031 6-May-26 Renewal Due Russian Federation KODATEF Registered 2016720181 6-Jun-16 7/10/2017 623174 0081716-000032 6-Jun-26 Renewal Due Singapore KODATEF Registered 40201707950V 2-May-17 11/8/2017 40201707950V 0081716-000040 2-May-27 Renewal Due United Kingdom ARAKODA Registered 17900852 16-May-18 9/20/2018 UK00917900852 0081716-000054 16-May-28 Renewal Due United Kingdom KODATEF Registered 15508872 3-Jun-16 9/21/2016 UK009015508872 0081716-000072 3-Jun-26 Renewal Due United States of America TQ 100 & TABLET DESIGN Registered 87608493 14-Sep-17 9/11/2018 5562900 0081716-000037 11-Sep-24 Section 8 & 15 Due United States of America ARAKODA Registered 87688137 16-Nov-17 12/31/2019 5950691 0081716-000050 31-Dec-25 Section 8 & 15 Due United States of America KODATEF Abandoned- 90072885 24-Jul-20 0081716-000069 16-Aug-23 Statement of Use/3rd Extension of Time Due United States of America KODATEF Allowed 98/363,219 18-Jan-24 0081716-000074 12-May-25 Statement of Use/1 st Extension of Time Due Key Relationships & Licenses On May 30, 2014, we entered into the Exclusive License Agreement (the “2014 NUS-SHS Agreement”) with National University of Singapore (“NUS”) and Singapore Health Services Pte Ltd (“SHS”) in which we were granted a license from NUS and SHS with respect to their share of patent rights regarding “Dosing Regimen for Use of Celgosivir as an Antiviral Therapeutic for Dengue Virus Infection” to develop, market and sell licensed products.
All estimated patent expiration dates and anticipated patent expiration assume payment of any maintenance/annuity fees during the patent term. 17 Trademarks Country Mark Status Application Number Date Filed Registration Date Registration Number BIR Ref Number Due Date Due Date Description Australia KODATEF Registered 1774631 2-Jun-16 6/2/2016 1774631 0081716-000029 2-Jun-26 Renewal Due Canada KODATEF Registered 1785098 1-Jun-16 11/26/2019 TMA1,064,371 0081716-000028 26-Nov-29 Renewal Due Canada ARAKODA Registered 1899317 15-May-18 8/20/2020 TMA1,081,180 0081716-000053 20-Aug-30 Renewal Due China KODATEF Registered 20842242 2-Aug-16 9/28/2017 20842242 0081716-000035 27-Sep-27 Renewal Due European Union KODATEF Registered 15508872 3-Jun-16 9/21/2016 15508872 0081716-000034 3-Jun-26 Renewal Due European Union ARAKODA Registered 17900852 16-May-18 9/20/2018 17900852 0081716-000054 16-May-28 Renewal Due Israel KODATEF Registered 285476 6-Jun-16 6/6/2016 285476 0081716-000033 6-Jun-26 Renewal Due New Zealand KODATEF Registered 1044407 7-Jun-16 12/8/2016 1044407 0081716-000031 6-May-26 Renewal Due Russian Federation KODATEF Registered 2016720181 6-Jun-16 7/10/2017 623174 0081716-000032 6-Jun-26 Renewal Due Singapore KODATEF Registered 40201707950V 2-May-17 11/8/2017 40201707950V 0081716-000040 2-May-27 Renewal Due United Kingdom ARAKODA Registered 17900852 16-May-18 9/20/2018 UK00917900852 0081716-000054 16-May-28 Renewal Due United Kingdom KODATEF Registered 15508872 3-Jun-16 9/21/2016 UK009015508872 0081716-000072 3-Jun-26 Renewal Due United States of America TQ 100 & TABLET DESIGN Registered 87608493 14-Sep-17 9/11/2018 5562900 0081716-000037 11-Sep-24 Section 8 & 15 Due United States of America ARAKODA Registered 87688137 16-Nov-17 12/31/2019 5950691 0081716-000050 31-Dec-25 Section 8 & 15 Due United States of America KODATEF Abandoned- 90072885 24-Jul-20 0081716-000069 16-Aug-23 Statement of Use/3rd Extension of Time Due United States of America KODATEF Allowed 98/363,219 18-Jan-24 0081716-000074 12-May-25 Statement of Use/1st Extension of Time Due 18 Key Relationships & Licenses On May 30, 2014, we entered into the Exclusive License Agreement (the “2014 NUS-SHS Agreement”) with National University of Singapore (“NUS”) and Singapore Health Services Pte Ltd (“SHS”) in which we were granted a license from NUS and SHS with respect to their share of patent rights regarding “Dosing Regimen for Use of Celgosivir as an Antiviral Therapeutic for Dengue Virus Infection” to develop, market and sell licensed products.
Such restrictions under applicable federal and state healthcare laws and regulations, include the following: ● the federal Anti-Kickback Statute, which prohibits, among other things, persons and entities from knowingly and willfully soliciting, offering, receiving or providing remuneration (including any kickback, bribe or rebate), directly or indirectly, in cash or in kind, to induce or reward either the referral of an individual for, or the purchase, lease or order of, any good or service, for which payment may be made, in whole or in part, under a federal healthcare program such as Medicare and Medicaid; 36 ● the federal civil and criminal false claims laws, including the civil False Claims Act, and civil monetary penalties laws, which prohibit individuals or entities from, among other things, knowingly presenting, or causing to be presented, to the federal government, claims for payment that are false or fraudulent or making a false statement to avoid, decrease or conceal an obligation to pay money to the federal government; ● the federal Health Insurance Portability and Accountability Act of 1996, which created additional federal criminal laws that prohibit, among other things, knowingly and willingly executing, or attempting to execute, a scheme or making false statements in connection with the delivery of or payment for health care benefits, items, or services; ● HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act and its implementing regulations, which also imposes obligations, including mandatory contractual terms, with respect to safeguarding the privacy, security and transmission of individually identifiable health information on covered entities and their business associates that associates that perform certain functions or activities that involve the use or disclosure of protected health information on their behalf; ● the federal transparency requirements known as the federal Physician Payments Sunshine Act, under the Patient Protection and Affordable Care Act, as amended by the Health Care Education Reconciliation Act (collectively the “ACA”), which requires certain manufacturers of drugs, devices, biologics and medical supplies for which payment is available under Medicare, Medicaid, or the Children’s Health Insurance Program, with specific exceptions, to report annually to the Centers for Medicare & Medicaid Services (“CMS”), within the U.S.
Such restrictions under applicable federal and state healthcare laws and regulations, include the following: the federal Anti-Kickback Statute, which prohibits, among other things, persons and entities from knowingly and willfully soliciting, offering, receiving or providing remuneration (including any kickback, bribe or rebate), directly or indirectly, in cash or in kind, to induce or reward either the referral of an individual for, or the purchase, lease or order of, any good or service, for which payment may be made, in whole or in part, under a federal healthcare program such as Medicare and Medicaid; the federal civil and criminal false claims laws, including the civil False Claims Act, and civil monetary penalties laws, which prohibit individuals or entities from, among other things, knowingly presenting, or causing to be presented, to the federal government, claims for payment that are false or fraudulent or making a false statement to avoid, decrease or conceal an obligation to pay money to the federal government; the federal Health Insurance Portability and Accountability Act of 1996, which created additional federal criminal laws that prohibit, among other things, knowingly and willingly executing, or attempting to execute, a scheme or making false statements in connection with the delivery of or payment for health care benefits, items, or services; 34 HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act and its implementing regulations, which also imposes obligations, including mandatory contractual terms, with respect to safeguarding the privacy, security and transmission of individually identifiable health information on covered entities and their business associates that associates that perform certain functions or activities that involve the use or disclosure of protected health information on their behalf; the federal transparency requirements known as the federal Physician Payments Sunshine Act, under the Patient Protection and Affordable Care Act, as amended by the Health Care Education Reconciliation Act (collectively the “ACA”), which requires certain manufacturers of drugs, devices, biologics and medical supplies for which payment is available under Medicare, Medicaid, or the Children’s Health Insurance Program, with specific exceptions, to report annually to the Centers for Medicare & Medicaid Services (“CMS”), within the U.S.
An applicant seeking approval to market and distribute a new drug product in the United States must typically undertake the following: ● completion of preclinical laboratory tests, animal studies and formulation studies in compliance with the FDA’s good laboratory practice regulations; ● submission to the FDA of an IND, which must take effect before human clinical trials may begin; ● approval by an independent institutional review board representing each clinical site before each clinical trial may be initiated; ● performance of adequate and well-controlled human clinical trials in accordance with good clinical practices to establish the safety and efficacy of the proposed drug product for each indication; ● preparation and submission to the FDA of a new drug application; ● review of the product by an FDA advisory committee, where appropriate or if applicable; ● satisfactory completion of one or more FDA inspections of the manufacturing facility or facilities at which the product, or components thereof, are produced to assess compliance with cGMP, requirements and to assure that the facilities, methods and controls are adequate to preserve the product’s identity, strength, quality and purity; ● satisfactory completion of FDA audits of clinical trial sites to assure compliance with GCPs and the integrity of the clinical data; ● payment of user fees and securing FDA approval of the NDA; and ● compliance with any post-approval requirements, including Risk Evaluation and Mitigation Strategies and post-approval studies required by the FDA. 19 Preclinical Studies Preclinical studies include laboratory evaluation of the purity and stability of the manufactured drug substance or active pharmaceutical ingredient and the formulated drug or drug product, as well as in vitro and animal studies to assess the safety and activity of the drug for initial testing in humans and to establish a rationale for therapeutic use.
An applicant seeking approval to market and distribute a new drug product in the United States must typically undertake the following: completion of preclinical laboratory tests, animal studies and formulation studies in compliance with the FDA’s good laboratory practice regulations; submission to the FDA of an IND, which must take effect before human clinical trials may begin; approval by an independent institutional review board representing each clinical site before each clinical trial may be initiated; performance of adequate and well-controlled human clinical trials in accordance with good clinical practices to establish the safety and efficacy of the proposed drug product for each indication; preparation and submission to the FDA of a new drug application; review of the product by an FDA advisory committee, where appropriate or if applicable; satisfactory completion of one or more FDA inspections of the manufacturing facility or facilities at which the product, or components thereof, are produced to assess compliance with cGMP, requirements and to assure that the facilities, methods and controls are adequate to preserve the product’s identity, strength, quality and purity; satisfactory completion of FDA audits of clinical trial sites to assure compliance with GCPs and the integrity of the clinical data; payment of user fees and securing FDA approval of the NDA; and compliance with any post-approval requirements, including Risk Evaluation and Mitigation Strategies and post-approval studies required by the FDA. 21 Preclinical Studies Preclinical studies include laboratory evaluation of the purity and stability of the manufactured drug substance or active pharmaceutical ingredient and the formulated drug or drug product, as well as in vitro and animal studies to assess the safety and activity of the drug for initial testing in humans and to establish a rationale for therapeutic use.
Although Lyme in the acute phase is generally viewed by the medical community as being treatable with antibiotics, individuals who are not treated, or fail treatment, may go on to develop long term, and potentially debilitating, chronic symptoms such as fatigue, body aches, and cognitive problems. 1 This condition is defined by the Centers for Disease Control and Prevention (“CDC”) as Post-Treatment Lyme Disease Syndrome (“PTLDS”) or simply as Lyme in the patient community. 1 Although there are no published estimates, key opinion leaders have stated that as many as 50% of Lyme/PTLDS patients are believed to be co-infected with Babesia parasites, a diagnosis referred to in the Lyme community as “Chronic Babesiosis.” Prescribers in the Lyme disease community utilize a number of therapeutic modalities to manage the symptoms of Chronic Babesiosis, including FDA-approved pharmaceuticals such as atovaquone and azithromycin (these are assumed to suppress the growth of Babesia parasites). 2 Recent market data shows that Tafenoquine appears to be increasingly prescribed by Lyme physicians to manage Chronic Babesiosis.
Although Lyme in the acute phase is generally viewed by the medical community as being treatable with antibiotics, individuals who are not treated, or fail treatment, may go on to develop long term, and potentially debilitating, chronic symptoms such as fatigue, body aches, and cognitive problems. 1 This condition is defined by the Centers for Disease Control and Prevention (“CDC”) as Post-Treatment Lyme Disease Syndrome (“PTLDS”) or simply as Lyme in the patient community. 1 Although there are no published estimates, key opinion leaders have stated that as many as 50% of Lyme/PTLDS patients are believed to be co-infected with Babesia parasites, a diagnosis referred to in the Lyme community as “Chronic Babesiosis.” Prescribers in the Lyme disease community utilize a number of therapeutic modalities to manage the symptoms of Chronic Babesiosis, including FDA-approved pharmaceuticals such as atovaquone and azithromycin (these are assumed to suppress the growth of Babesia parasites). 2 Recent market data shows that Tafenoquine (primarily as Arakoda) appears to be increasingly prescribed by Lyme physicians to manage Chronic Babesiosis.
The trial (NCT06207370) evaluates tafenoquine combined with standard treatment for babesiosis, addressing a critical unmet medical need. The double-blind, placebo-controlled trial will examine outcomes for hospitalized patients with severe babesiosis, a tick-borne illness often found as a co-infection of Lyme disease. 4 ARAKODA® Promotional Pilot in Advance of Expanded U.S.
The trial (NCT06207370) evaluates tafenoquine combined with standard treatment for babesiosis, addressing a critical unmet medical need. The double-blind, placebo-controlled trial will examine outcomes for hospitalized patients with severe babesiosis, a tick-borne illness often found as a co-infection of Lyme disease. ARAKODA® Promotional Pilot in Advance of Expanded U.S.
Registration ● Sponsor applies to register the product on the Australian Register of Therapeutic Goods. ● Supply is permitted once the applicable number is allocated. 34 The drug’s chemistry, toxicology and clinical use are evaluated using data submitted by the sponsoring company. Most of the evaluations are done within the TGA, but external evaluations can be used.
Registration Sponsor applies to register the product on the Australian Register of Therapeutic Goods. Supply is permitted once the applicable number is allocated. The drug’s chemistry, toxicology and clinical use are evaluated using data submitted by the sponsoring company. Most of the evaluations are done within the TGA, but external evaluations can be used.
The features and benefits of Tafenoquine for malaria prophylaxis, some of which have been noted by third-party experts, include: convenient once weekly dosing following a three day load; the absence of reports of drug resistance during malaria prophylaxis; activity against liver and blood stages of malaria as well as both the major malaria species ( Plasmodium vivax and Plasmodium falciparum ); absence of any black-box safety warnings; good tolerability, including in women and individuals with prior psychiatric medical history; and a comparable adverse event rate to placebo with up to 12 months continuous dosing. 23 Tafenoquine entered the commercial supply chains in the U.S. and Australia in the third quarter of 2019.
The features and benefits of Tafenoquine for malaria prophylaxis, some of which have been noted by third-party experts, include: convenient once weekly dosing following a three-day load; the absence of reports of drug resistance during malaria prophylaxis; activity against liver and blood stages of malaria as well as both the major malaria species ( Plasmodium vivax and Plasmodium falciparum ); absence of any black-box safety warnings; good tolerability, including in women and individuals with prior psychiatric medical history; and a comparable adverse event rate to placebo with up to 12 months continuous dosing. 18 Tafenoquine entered the commercial supply chains in the U.S. and Australia in the third quarter of 2019.
These increases are essential to attract and retain qualified employees, directors and consultants, and to align their interests with those of our stockholders. September 2024 Private Placement On September 4, 2024, we entered into a securities purchase agreement (the “Purchase Agreement”) with a single institutional investor.
These increases are essential to attract and retain qualified employees, directors and consultants, and to align their interests with those of our stockholders. 5 September 2024 Private Placement On September 4, 2024, we entered into a securities purchase agreement (the “Purchase Agreement”) with a single institutional investor.
For variations to the registration of a drug, the TGA must raise an objection within 45 working days, otherwise the application is deemed to be approved. Pharmaceutical Coverage, Pricing and Reimbursement Significant uncertainty exists as to the coverage and reimbursement status of products approved by the FDA and other government authorities.
For variations to the registration of a drug, the TGA must raise an objection within 45 working days, otherwise the application is deemed to be approved. 33 Pharmaceutical Coverage, Pricing and Reimbursement Significant uncertainty exists as to the coverage and reimbursement status of products approved by the FDA and other government authorities.
There are up to 38,000 cases of potentially treatable acute symptomatic babesiosis (red blood cell infections caused by deer tick bites) in the United States each year. 9 Approximately 650 of these cases are hospitalizations, a smaller fraction of which represents immunosuppressed individuals. 10 Symptomatic babesiosis is usually treated with a minimum ten day course of atovaquone and azithromycin which is extended to six weeks in the immunosuppressed, who may also experience relapses requiring multiple hospitalizations. 11 This is much longer than equivalent serious parasitic diseases such as malaria where the goal is a three-day regimen.
There are up to 119,000 cases of potentially treatable acute symptomatic babesiosis (red blood cell infections caused by deer tick bites) in the United States each year. 9 Approximately 650 of these cases are hospitalizations, a smaller fraction of which represents immunosuppressed individuals. 10 Symptomatic babesiosis is usually treated with a minimum ten day course of atovaquone and azithromycin which is extended to six weeks in the immunosuppressed, who may also experience relapses requiring multiple hospitalizations. 11 This is much longer than equivalent serious parasitic diseases such as malaria where the goal is a three-day regimen.
We proposed to the FDA, in late 2021, that this might not be safe to execute given that malaria prevention is administered to asymptomatic individuals and that methemoglobinemia (damage to the hemoglobin in blood that carries oxygen) occurred in 5% of patients, and exceeded a level of 10% in 3% of individuals in a study conducted by another sponsor in pediatric subjects with symptomatic vivax malaria. 37 The FDA has asked us to propose an alternate design, for which we submitted a concept protocol in the fourth quarter of 2022, and submitted a full protocol in July, 2024.
We proposed to the FDA, in late 2021, that this might not be safe to execute given that malaria prevention is administered to asymptomatic individuals and that methemoglobinemia (damage to the hemoglobin in blood that carries oxygen) occurred in 5% of patients, and exceeded a level of 10% in 3% of individuals in a study conducted by another sponsor in pediatric subjects with symptomatic vivax malaria. 34 The FDA has asked us to propose an alternate design, for which we submitted a concept protocol in the fourth quarter of 2022, and submitted a full protocol in July 2024.
Estimated/ Anticipated Expiration Date Dosing Regimen For Use Of Celgosivir As An Antiviral Therapeutic For Dengue Virus Infections 2013203400 Australia 2013203400 + 10-April-2033* Novel Dosing Regimens Of Celgosivir For The Treatment Of Dengue 2014228035 Australia 2014228035 14-Mar-2034* Novel Dosing Regimens Of Celgosivir For The Treatment Of Dengue MY-170991-A Malaysia PI2015002372 14-Mar-2034* Novel Dosing Regimens Of Celgosivir For The Treatment Of Dengue 378015 Mexico MX/a/2015/013115 14-Mar-2034* Novel Dosing Regimens Of Celgosivir For The Treatment Of Dengue 11201507254V Singapore 11201507254V 14-Mar-2034* Novel Dosing Regimens Of Celgosivir For The Treatment Of Dengue Pending Singapore Pending 10201908089V 14-Mar-2034* Novel Dosing Regimens Of Celgosivir For The Treatment Of Dengue 9763921 US 9/19/2017 14/772,873 14-Mar-2034 ^ Novel Dosing Regimens Of Celgosivir For The Treatment Of Dengue 10517854 US 12/31/2019 15/706,845 14-Mar-2034 ^ Dosing Regimens Of Celgosivir For The Treatment Of Dengue 11219616 US 1/11/2022 16/725,387 14-Mar-2034 ^ Novel Regimens Of Tafenoquine For Prevention Of Malaria In Malaria-Naïve Subjects 2015358566 Australia 2015358566 02-Dec-2035* Regimens Of Tafenoquine For Prevention Of Malaria In Malaria-Naïve Subjects 2968694 Canada 2968694 02-Dec-2035* Novel Regimens Of Tafenoquine For Prevention Of Malaria In Malaria-Naïve Subjects 10342791 US 7/9/2019 15/532,280 02-Dec-2035 ^ Regimens Of Tafenoquine For Prevention Of Malaria In Malaria-Naive Subjects 10888558 US 1/12/2021 16/504,533 02-Dec-2035 ^ Novel Regimens Of Tafenoquine For Prevention Of Malaria In Malaria-Naïve Subjects Pending Singapore Pending 10201904908Q 02-Dec-2035* Novel Regimens Of Tafenoquine For Prevention Of Malaria In Malaria-Naïve Subjects Pending EP Pending 15865264.4 02-Dec-2035* Novel Regimens Of Tafenoquine For Prevention Of Malaria In Malaria-Naïve Subjects Pending Hong Kong Pending 18103081.4 02-Dec-2035* 13 Title Patent No.
Estimated/ Anticipated Expiration Date Dosing Regimen For Use Of Celgosivir As An Antiviral Therapeutic For Dengue Virus Infections 2013203400 Australia 2013203400 + 10-Apr-2033* Novel Dosing Regimens Of Celgosivir For The Treatment Of Dengue 2014228035 Australia 2014228035 14-Mar-2034* Novel Dosing Regimens Of Celgosivir For The Treatment Of Dengue MY-170991-A Malaysia PI2015002372 14-Mar-2034* Novel Dosing Regimens Of Celgosivir For The Treatment Of Dengue 378015 Mexico MX/a/2015/013115 14-Mar-2034* Novel Dosing Regimens Of Celgosivir For The Treatment Of Dengue 11201507254V Singapore 11201507254V 14-Mar-2034* Novel Dosing Regimens Of Celgosivir For The Treatment Of Dengue Pending Singapore Pending 10201908089V 14-Mar-2034* Novel Dosing Regimens Of Celgosivir For The Treatment Of Dengue 9763921 US 9/19/2017 14/772,873 14-Mar-2034** Novel Dosing Regimens Of Celgosivir For The Treatment Of Dengue 10517854 US 12/31/2019 15/706,845 14-Mar-2034** Dosing Regimens Of Celgosivir For The Treatment Of Dengue 11219616 US 1/11/2022 16/725,387 14-Mar-2034** Novel Regimens Of Tafenoquine For Prevention Of Malaria In Malaria-Naïve Subjects 2015358566 Australia 2015358566 02-Dec-2035* Regimens Of Tafenoquine For Prevention Of Malaria In Malaria-Naïve Subjects 2968694 Canada 2968694 02-Dec-2035* Novel Regimens Of Tafenoquine For Prevention Of Malaria In Malaria-Naïve Subjects 10342791 US 7/9/2019 15/532,280 02-Dec-2035** Regimens Of Tafenoquine For Prevention Of Malaria In Malaria-Naive Subjects 10888558 US 1/12/2021 16/504,533 02-Dec-2035** Novel Regimens Of Tafenoquine For Prevention Of Malaria In Malaria-Naïve Subjects 10201904908Q Singapore 10201904908Q 02-Dec-2035* Novel Regimens Of Tafenoquine For Prevention Of Malaria In Malaria-Naïve Subjects Pending EP Pending 15865264.4 02-Dec-2035* Novel Regimens Of Tafenoquine For Prevention Of Malaria In Malaria-Naïve Subjects Pending Hong Kong Pending 18103081.4 02-Dec-2035* 14 Title Patent No.
When the modification involves a change in material, the nature of the “new” material will determine whether a traditional or Special 510(k) is necessary. 30 Review and Approval of Drug Products in the European Union In order to market any product outside of the United States, a company must also comply with numerous and varying regulatory requirements of other countries and jurisdictions regarding quality, safety and efficacy and governing, among other things, clinical trials, marketing authorization, commercial sales and distribution of products.
When the modification involves a change in material, the nature of the “new” material will determine whether a traditional or Special 510(k) is necessary. 29 Review and Approval of Drug Products in the European Union In order to market any product outside of the United States, a company must also comply with numerous and varying regulatory requirements of other countries and jurisdictions regarding quality, safety and efficacy and governing, among other things, clinical trials, marketing authorization, commercial sales and distribution of products.
If a member state cannot approve the assessment report and related materials on the grounds of potential serious risk to public health, the disputed points are subject to a dispute resolution mechanism and may eventually be referred to the European Commission, whose decision is binding on all member states. 31 Clinical Trial Approval Requirements for the conduct of clinical trials in the European Union including Good Clinical Practice, are set forth in the Clinical Trials Directive 2001/20/EC and the GCP Directive 2005/28/EC.
If a member state cannot approve the assessment report and related materials on the grounds of potential serious risk to public health, the disputed points are subject to a dispute resolution mechanism and may eventually be referred to the European Commission, whose decision is binding on all member states. 30 Clinical Trial Approval Requirements for the conduct of clinical trials in the European Union including Good Clinical Practice, are set forth in the Clinical Trials Directive 2001/20/EC and the GCP Directive 2005/28/EC.
Clinical trial(s) to prove safety and efficacy, and approval by FDA and other regulators, would be required before Tafenoquine could be marketed for these indications. 23 Tan and Hwang Journal of Travel Medicine, 2018, 1–2; Baird Journal of Travel Medicine 2018:, 1–13; Schlagenhauf et al Travel Medicine and Infectious Disease 2022; 46:102268; See Arakoda prescribing information at www.arakoda.com; McCarthy et al CID 2019:69:480-486; Dow et al.
Clinical trial(s) to prove safety and efficacy, and approval by FDA and other regulators, would be required before Tafenoquine could be marketed for these indications. 18 Tan and Hwang Journal of Travel Medicine, 2018, 1–2; Baird Journal of Travel Medicine 2018:, 1–13; Schlagenhauf et al Travel Medicine and Infectious Disease 2022; 46:102268; See Arakoda prescribing information at www.arakoda.com; McCarthy et al CID 2019:69:480-486; Dow et al.
A clinical study, conducted in Singapore, the results of which were accepted for publication in the peer-reviewed journal Lancet Infectious Diseases, confirmed its safety but the observed reduction in viral load was lower than what the study was powered to detect. 31 Celgosivir (as with other Dengue antivirals) exhibits greater capacity to cure Dengue infections in animal models when administered prior to symptom onset when compared to administration post-symptom onset.
A clinical study, conducted in Singapore, the results of which were accepted for publication in the peer-reviewed journal Lancet Infectious Diseases, confirmed its safety but the observed reduction in viral load was lower than what the study was powered to detect. 26 Celgosivir (as with other Dengue antivirals) exhibits greater capacity to cure Dengue infections in animal models when administered prior to symptom onset when compared to administration post-symptom onset.
We believe, if the Company does not become capital-limited, and no recruitment issues are encountered, that the results of one or more of the above studies will come to fruition in the first quarter of 2026, potentially facilitating submission of a supplementary new drug application (or other appropriate regulatory filing) to FDA, with the goal of obtaining marketing approval of Arakoda for treatment of Babesiosis.
We believe, if the Company does not become capital-limited, and no recruitment issues are encountered, that the results of one or more of the above studies will come to fruition in the third quarter of 2026, potentially facilitating submission of a supplementary new drug application (or other appropriate regulatory filing) to FDA, with the goal of obtaining marketing approval of Arakoda for treatment of Babesiosis.
First Patient in Tafenoquine Expanded Access Clinical Study for Persistent (B. microti) Babesiosis On January 8, 2025, we announced that the first patient has been enrolled in NCT06478641, an expanded access clinical study intended to confirm the activity of tafenoquine in treating patients with persistent babesiosis who have failed standard of care treatment and are at high risk of experiencing a relapse.
First Patient in Tafenoquine Expanded Access Clinical Study for Persistent (B. microti) Babesiosis On January 8, 2025, we announced that the first patient had been enrolled in NCT06478641, an expanded access clinical study intended to confirm the activity of tafenoquine in treating patients with persistent babesiosis who have failed standard of care treatment and are at high risk of experiencing a relapse.
In animal models, this problem can be addressed by administering the same dose of drug split into four doses per day rather than two doses per day (as was the case in the Singaporean clinical trial). 32 This observation led to the filing and approval of a patent related to Dengue, which we licensed from the National University of Singapore.
In animal models, this problem can be addressed by administering the same dose of drug split into four doses per day rather than two doses per day (as was the case in the Singaporean clinical trial). 27 This observation led to the filing and approval of a patent related to Dengue, which we licensed from the National University of Singapore.
The issuance of the January 2025 Warrants pursuant to the January 2025 Securities Purchase Agreement and issuance of the January 2025 Placement Agent Warrants (defined below) were made pursuant to the exemption from the registration requirements under the Securities Act of 1933, as amended (the “Securities Act”), available to the Company under Section 4(a)(2) promulgated thereunder and Rule 506 of Regulation D promulgated under the Securities Act due to the fact the offering of the January 2025 Warrants and the January 2025 Placement Agent Warrants thereunder did not involve a public offering of securities.
The issuance of the January 2025 Warrants pursuant to the January 2025 Securities Purchase Agreement and issuance of the January 2025 Placement Agent Warrants (defined below) were made pursuant to the exemption from the registration requirements under the Securities Act of 1933, as amended, available to the Company under Section 4(a)(2) promulgated thereunder and Rule 506 of Regulation D promulgated under the Securities Act due to the fact the offering of the January 2025 Warrants and the January 2025 Placement Agent Warrants thereunder did not involve a public offering of securities.
The information contained in, or that can be accessed through, our website is not part of this Annual Report on Form 10-K.
The information contained in, or that can be accessed through, our website is not part of this Annual Report on Form 10-K. 36
This trend may follow the recent publication of several case reports demonstrating activity in immunosuppressed patients with acute babesiosis, and animal data showing eradication of Babesia parasites with Tafenoquine (primarily as Arakoda). 3 The Company believes the recent increases in sales of Arakoda have been driven by organic growth of these activities.
This trend may follow the recent publication of several case reports demonstrating activity in immunosuppressed patients with acute babesiosis, and animal data showing eradication of Babesia parasites with Tafenoquine. 3 The Company believes the recent increases in sales of Arakoda have been driven by organic growth of these activities.
The value those advantages confer needs to be communicated with key stakeholders. Market Segment, Targeting, and Commercial Pilot . We purchased market data to understand the malaria market landscape over the past decade and identified the current prescribers of Malarone and the generic equivalent atovaquone-proguanil, the main generic competitor to Arakoda for malaria prophylaxis.
The value those advantages confer needs to be communicated with key stakeholders. Market Segment, Targeting, and Commercial Update . We purchased market data to understand the malaria market landscape over the past decade and identified the current prescribers of Malarone and the generic equivalent atovaquone-proguanil, the main generic competitor to Arakoda for malaria prophylaxis.
The review process may be extended by the FDA for three additional months to consider new information or clarification provided by the applicant to address an outstanding deficiency identified by the FDA following the original submission. 22 Before approving an NDA, the FDA typically will inspect the facility or facilities where the product is or will be manufactured.
The review process may be extended by the FDA for three additional months to consider new information or clarification provided by the applicant to address an outstanding deficiency identified by the FDA following the original submission. 23 Before approving an NDA, the FDA typically will inspect the facility or facilities where the product is or will be manufactured.
Mission Our mission is to address the unmet medical need associated with infectious diseases through the development and commercialization of new small molecule therapeutics, focusing on synthetic drugs (made by chemists in labs, excluding biologics) with good safety profiles based on prior clinical studies, in order to reduce cost, risk, and capitalize on existing research.
Mission Our mission is to address the unmet medical need associated with vector-borne diseases through the development and commercialization of new small molecule therapeutics, focusing on synthetic drugs (made by chemists in labs, excluding biologics) with good safety profiles based on prior clinical studies, in order to reduce cost, risk, and capitalize on existing research.
We will monitor this issue to determine the effects of this legislation on our business – full implementation of the reforms may have a negative impact on maximizing the profitability, but the actual impact at this juncture is uncertain. 38 Human Capital Resources As of December 31, 2024, we had a total of three employees, all of whom are full-time.
We will monitor this issue to determine the effects of this legislation on our business – full implementation of the reforms may have a negative impact on maximizing the profitability, but the actual impact at this juncture is uncertain. Human Capital Resources As of December 31, 2025 , we had a total of three employees, all of whom are full-time.
Under this agreement, we agreed to submit an NDA for Tafenoquine to the FDA (as Arakoda), while the US Army agreed to finance the bulk of the necessary development activities in support of that goal. 22 Zottig et al Military Medicine 2020; 185 (S1): 687. 8 The FDA and Australia’s medicinal regulatory agency, the Therapeutic Goods Administration, subsequently approved Arakoda (brand name in the U.S.) and Kodatef (brand name in Australia), respectively, for prevention of malaria in travelers in 2018.
Under this agreement, we agreed to submit an NDA for Tafenoquine to the FDA (as Arakoda), while the US Army agreed to finance the bulk of the necessary development activities in support of that goal. 17 Zottig et al Military Medicine 2020; 185 (S1): 687. 9 The FDA and Australia’s medicinal regulatory agency, the Therapeutic Goods Administration, subsequently approved Arakoda (brand name in the U.S.) and Kodatef (brand name in Australia), respectively, for prevention of malaria in travelers in 2018.
Figure A Products Arakoda (Tafenoquine) for malaria prevention We entered into a cooperative research and development agreement with the United States Army in 2014 to complete development of Arakoda for prevention of malaria. 21 With the U.S.
Figure A Products Arakoda (Tafenoquine) for malaria prevention We entered into a cooperative research and development agreement with the United States Army in 2014 to complete development of Arakoda for prevention of malaria. 16 With the U.S.
Digital Revamp and Collateral: Our marketing strategy and objectives for the promotional pilot include marketing assets that we believe best highlight the features and benefits of Arakoda, namely the convenience of the travel and post-travel regimen, and global effectiveness and a co-pay benefit to reduce the out-of-pocket expense for individuals with commercial insurance.
Digital Revamp and Collateral: Our marketing strategy and objectives for our commercial outreach include marketing assets that we believe best highlight the features and benefits of Arakoda, namely the convenience of the travel and post-travel regimen, and global effectiveness and a co-pay benefit to reduce the out-of-pocket expense for individuals with commercial insurance.
The Series A Warrants and Series B Warrants have an exercise price of $6.90 per share and were exercisable beginning on the effective date of stockholder approval of the issuance of the shares of Common Stock upon exercise of the Common Warrants and the Placement Agent Warrants (discussed below), which was received November 6, 2024 (the “Stockholder Approval”).
The Series A Warrants and Series B Warrants have an exercise price of $ 27.60 per share and were exercisable beginning on the effective date of stockholder approval of the issuance of the shares of Common Stock upon exercise of the Common Warrants and the Placement Agent Warrants (discussed below), which was received November 6, 2024 (the “Stockholder Approval”).
In addition, the Company paid for certain non-accountable expenses in the amount of $15,000 and a clearing fee in the amount of $10,000. The Company also issued to the Placement Agent (or its designees) warrants to purchase up to 15,325 shares of common stock (the “January 2025 Placement Agent Warrants”).
In addition, the Company paid for certain non-accountable expenses in the amount of $15,000 and a clearing fee in the amount of $10,000. The Company also issued to the Placement Agent (or its designees) warrants to purchase up to 3,833 shares of common stock (the “January 2025 Placement Agent Warrants”).
The Pre-Funded Warrants are exercisable immediately upon issuance and expire when exercised in full at an exercise price of $0.005 per share.
The Pre-Funded Warrants are exercisable immediately upon issuance and expire when exercised in full at an exercise price of $ 0.02 per share.
Pathogens 2022;11:1015. 29 Krause et al Clin Infect Dis 2024; doi:10.1093/cid/ciae238. 9 Celgosivir Celgosivir is a host targeted glucosidase inhibitor that was developed separately by other sponsors for HIV then for hepatitis C. 30 The sponsors abandoned Celgosivir after completion of Phase II clinical trials involving 700+ patients, because other antivirals in development at the time had superior activity.
Pathogens 2022;11:1015. 24 Krause et al Clin Infect Dis 2024; doi:10.1093/cid/ciae238. 10 Celgosivir Celgosivir is a host targeted glucosidase inhibitor that was developed separately by other sponsors for HIV then for hepatitis C. 25 The sponsors abandoned Celgosivir after completion of Phase II clinical trials involving 700+ patients, because other antivirals in development at the time had superior activity.
The issuance of the February 2025 Warrants pursuant to the February 2025 Securities Purchase Agreement and issuance of the February 2025 Placement Agent Warrants (defined below) were made pursuant to the exemption from the registration requirements under the Securities Act, available to the Company under Section 4(a)(2) promulgated thereunder and Rule 506 of Regulation D promulgated under the Securities Act due to the fact the offering of the February 2025 Common Warrants and the February 2025 Placement Agent Warrants thereunder did not involve a public offering of securities. 2 The February 2025 Securities Purchase Agreement contained customary representations and warranties.
The issuance of the February 2025 Warrants pursuant to the February 2025 Securities Purchase Agreement and issuance of the February 2025 Placement Agent Warrants (defined below) were made pursuant to the exemption from the registration requirements under the Securities Act, available to the Company under Section 4(a)(2) promulgated thereunder and Rule 506 of Regulation D promulgated under the Securities Act due to the fact the offering of the February 2025 Common Warrants and the February 2025 Placement Agent Warrants thereunder did not involve a public offering of securities.
We plan to introduce an 8-count bottle of ARAKODA NCD # 71475-257-02 into the supply chain in Q2. Repositioning of Arakoda Relative to Malarone and Generic Equivalent Atovaquone-Proguanil . A malaria demand study was conducted to assess the attractiveness and acceptability of the Arakoda product profile and current pricing among health care providers and consumers.
We introduced an 8-count bottle of ARAKODA NCD # 71475-257-02 into the supply chain in Q2 of 2025. Repositioning of Arakoda Relative to Malarone and Generic Equivalent Atovaquone-Proguanil . A malaria demand study was conducted to assess the attractiveness and acceptability of the Arakoda product profile and current pricing among health care providers and consumers.
The value of each outstanding member’s membership interest in 60P LLC was correspondingly converted into common stock of 60 Degrees Pharmaceuticals, Inc., par value $0.0001 per share, with a cost-basis equal to $300.00 per share. We also operate one subsidiary. A summary of our majority-owned subsidiary is below.
The value of each outstanding membership interest in 60P LLC was correspondingly converted into common stock of 60 Degrees Pharmaceuticals, Inc., par value $0.0001 per share, with a cost-basis equal to $1,200.00 per share. We also operate one subsidiary. A summary of our majority-owned subsidiary is below.
The only limitation of Arakoda is the requirement for a G6PD test prior to administration. 24 The G6PD test must be administered to a prospective patient prior to administration of Arakoda in order to prevent the potential occurrence of hemolytic anemia in individuals with G6PD deficiency. 25 G6PD is one of the most common enzyme deficiencies and is implicated in hemolysis following administration/ingestion of a variety of oxidant drugs/food.
The only limitation of Arakoda is the requirement for a G6PD test prior to administration. 19 The G6PD test must be administered to a prospective patient prior to administration of Arakoda in order to prevent the potential occurrence of hemolytic anemia in individuals with G6PD deficiency. 20 G6PD is one of the most common enzyme deficiencies and is implicated in hemolysis following administration/ingestion of a variety of oxidant drugs/food.
Arakoda Sales Hiring of Chief Commercial Officer . In February 2024, we hired Kristen Landon to lead our commercial efforts to reintroduce Arakoda for malaria prevention and conduct new product planning initiatives in tick-borne disease for babesiosis.
Expansion of U.S. Arakoda Sales Hiring of Chief Commercial Officer. In February 2024, we hired Kristen Landon to lead our commercial efforts to reintroduce Arakoda for malaria prevention and conduct new product planning initiatives in tick-borne disease for babesiosis.
In a recently published case series Tafenoquine in combination with standard of care cured 80% of immunosuppressed patients with relapsing babesiosis and the investigators stated in a press release that “Tafenoquine is going to make a huge difference, I think, in people who are severely immunocompromised.” 12 1 See https://www.cdc.gov/lyme/signs-symptoms/chronic-symptoms-and-lyme-disease.html. 2 Conclusions from Company-commissioned market research. 3 Conclusions from Company-commissioned market research. 4 Maximum prevalence determined by multiplying the rate of Babesia coinfection in PTLDS patients (52%, from Parveen & Bhanot, Pathogens 2019;8(3):117) by the highest estimate of the cumulative prevalence of PTLDS (1,994,189, from Delong et al.
In a recently published case series Tafenoquine in combination with standard of care cured 80% of immunosuppressed patients with relapsing babesiosis and the investigators stated in a press release that “Tafenoquine is going to make a huge difference, I think, in people who are severely immunocompromised.” 12 1 See https://www.cdc.gov/lyme/signs-symptoms/chronic-symptoms-and-lyme-disease.html. 2 Conclusions from Company-commissioned market research. 3 Conclusions from Company-commissioned market research. 4 Previously, we had estimated the maximum prevalence of chronic babesiosis to be 1.01 million by multiplying the rate of Babesia coinfection in PTLDS patients (52%, from Parveen & Bhanot, Pathogens 2019;8(3):117) by the highest estimate of the cumulative prevalence of PTLDS (1,994,189, from Delong et al.
The February 2025 Placement Agent Warrants have an exercise price equal to $4.469 per share and are exercisable upon issuance and expire twenty-four months from the date of issuance. The Company received net proceeds of $908,627 from the offering, after deducting estimated offering expenses paid by the Company, including the Placement Agent fees.
The February 2025 Placement Agent Warrants have an exercise price equal to $ 17.88 per share and are exercisable upon issuance and expire twenty-four months from the date of issuance. The Company received net proceeds of $908,627 from the offering, after deducting estimated offering expenses paid by the Company, including the Placement Agent fees.
The Company shall use commercially reasonable efforts to cause such registration statement to become effective within 75 days following the closing date of the February 2025 Offering and to keep such registration statement effective at all times until no February 2025 Purchaser owns any February 2025 Warrants or shares underlying the February 2025 Warrants issuable upon exercise thereof.
We agreed to use commercially reasonable efforts to cause such registration statement to become effective within 75 days following the closing date of the February 2025 Offering, and to keep such registration statement effective at all times until no February 2025 Purchaser owns any February 2025 Warrants or shares underlying the February 2025 Warrants issuable upon exercise thereof.
The Company shall use commercially reasonable efforts to cause such registration statement to become effective within 75 days following the closing date of the January 2025 Offering and to keep such registration statement effective at all times until no January 2025 Purchaser owns any January 2025 Warrants or shares underlying the January 2025 Warrants issuable upon exercise thereof.
We agreed to use commercially reasonable efforts to cause such registration statement to become effective within 75 days following the closing date of the January 2025 Offering, and to keep such registration statement effective at all times until no January 2025 Purchaser owns any January 2025 Warrants or shares underlying the January 2025 Warrants issuable upon exercise thereof.
According to the European CDC, Dengue is associated with at least 4.1 million cases globally. 19 And, according to the U.S.
According to the European CDC, Dengue is associated with at least 4.1 million cases globally. 14 And, according to the U.S.
Previously, at the 2024 Annual Meeting of Stockholders in July 2024, our stockholders approved an amendment to our Certificate of Incorporation to effect reverse stock split of our common stock at a range of ratios between 1:5 to 1:12, and on July 19, 2024, our Board approved the implementation of the reverse stock split at a ratio of 1:12 (the “1:12 Reverse Stock Split”, and together with the 1:5 Reverse Stock Split, the “Reverse Stock Splits”).
Previously, at the 2024 Annual Meeting of Stockholders in July 2024, our stockholders approved an amendment to our Certificate of Incorporation to effect reverse stock split of our common stock at a range of ratios between 1:5 to 1:12, and on July 19, 2024, our Board approved the implementation of the reverse stock split at a ratio of 1:12 (the “1:12 Reverse Stock Split”).
In addition, the Company paid for certain non-accountable expenses in the amount of $15,000 and a clearing fee in the amount of $10,000. The Company also issued to the Placement Agent (or its designees) warrants to purchase up to 22,554 shares of Common Stock (the “February 2025 Placement Agent Warrants”).
In addition, the Company paid for certain non-accountable expenses in the amount of $15,000 and a clearing fee in the amount of $10,000. The Company also issued to the Placement Agent (or its designees) warrants to purchase up to 5,640 shares of Common Stock (the “February 2025 Placement Agent Warrants”).
The history of that collaboration has been publicly communicated by the U.S. Army. 22 21 In 2014, we signed a cooperative research and development agreement with the United States Army Medical and Materiel Development Activity (Agreement W81XWH-14-0313).
The history of that collaboration has been publicly communicated by the U.S. Army. 17 16 In 2014, we signed a cooperative research and development agreement with the United States Army Medical and Materiel Development Activity (Agreement W81XWH-14-0313).
If successful, this will allow the Company to actively market Arakoda for Babesiosis. In March 2024, we initiated, in collaboration with the North Carolina State University College of Veterinary Medicine, a pilot study of Tafenoquine for treatment of canine babesiosis in the United States under a sponsored research program.
If successful, this will allow the Company to actively market Arakoda for Babesiosis. Tafenoquine for Veterinary Indications In March 2024, we initiated, in collaboration with the North Carolina State University College of Veterinary Medicine, a pilot study of Tafenoquine for treatment of canine babesiosis in the United States under a sponsored research program. That study is now complete.
The Purchase Agreement provided for the sale and issuance by us of an aggregate of: (i) Pre-Funded Warrants to purchase up to 579,711 Shares of our Common Stock, (ii) 579,711 shares of Common Stock issuable upon exercise of Series A Warrants, and (iii) 579,711 shares of Common Stock issuable upon exercise of Series B Warrants.
The Purchase Agreement provided for the sale and issuance by us of an aggregate of: (i) Pre-Funded Warrants to purchase up to 144,928 Shares of our Common Stock, (ii) 144,928 shares of Common Stock issuable upon exercise of Series A Warrants, and (iii) 144,928 shares of Common Stock issuable upon exercise of Series B Warrants.
Human clinical trials are typically conducted in the following sequential phases, which may overlap or be combined: ● Phase 1: The drug is initially introduced into healthy human subjects or, in certain indications such as cancer, patients with the target disease or condition and tested for safety, dosage tolerance, absorption, metabolism, distribution, excretion and, if possible, to gain an early indication of its effectiveness and to determine optimal dosage. ● Phase 2: The drug is administered to a limited patient population to identify possible adverse effects and safety risks, to preliminarily evaluate the efficacy of the product for specific targeted diseases and to determine dosage tolerance and optimal dosage. ● Phase 3: The drug is administered to an expanded patient population, generally at geographically dispersed clinical trial sites, in well-controlled clinical trials to generate enough data to statistically evaluate the efficacy and safety of the product for approval, to establish the overall risk-benefit profile of the product, and to provide adequate information for the labeling of the product. ● Phase 4: Post-approval studies, which are conducted following initial approval, are typically conducted to gain additional experience and data from treatment of patients in the intended therapeutic indication. 21 Progress reports detailing the results of the clinical trials must be submitted at least annually to the FDA and more frequently if serious adverse events occur.
Human clinical trials are typically conducted in the following sequential phases, which may overlap or be combined: Phase 1: The drug is initially introduced into healthy human subjects or, in certain indications such as cancer, patients with the target disease or condition and tested for safety, dosage tolerance, absorption, metabolism, distribution, excretion and, if possible, to gain an early indication of its effectiveness and to determine optimal dosage. Phase 2: The drug is administered to a limited patient population to identify possible adverse effects and safety risks, to preliminarily evaluate the efficacy of the product for specific targeted diseases and to determine dosage tolerance and optimal dosage. Phase 3: The drug is administered to an expanded patient population, generally at geographically dispersed clinical trial sites, in well-controlled clinical trials to generate enough data to statistically evaluate the efficacy and safety of the product for approval, to establish the overall risk-benefit profile of the product, and to provide adequate information for the labeling of the product. Phase 4: Post-approval studies, which are conducted following initial approval, are typically conducted to gain additional experience and data from treatment of patients in the intended therapeutic indication.
The January 2025 Placement Agent Warrants have an exercise price equal to $6.382 per share and are exercisable upon issuance, or January 30, 2025, for twenty-four months from the date of issuance, or January 30, 2027.
The January 2025 Placement Agent Warrants have an exercise price equal to $ 25.53 per share and are exercisable upon issuance, or January 30, 2025, for twenty-four months from the date of issuance, or January 30, 2027.
The Company, plans to offer an approximately three-month supply of Arakoda at no cost to patients who have a clinical diagnosis, are willing to submit biological samples for testing, and answer babesiosis and standardized fatigue inventories before and after treatment.
The Company is offering an approximately three-month supply of Arakoda at no cost to patients who have a clinical diagnosis of Chronic Babesiosis, are willing to submit biological samples for testing, and answer babesiosis and standardized fatigue inventories before and after treatment.
Pursuant to the February 2025 Securities Purchase Agreement, the Company is required to file a registration statement with the SEC within 45 days after the date of the February 2025 Securities Purchase Agreement to register the shares underlying the February 2025 Warrants under the Securities Act.
Pursuant to the February 2025 Securities Purchase Agreement, we were required to file a registration statement with the SEC within 45 days after the date of the February 2025 Securities Purchase Agreement to register the shares underlying the February 2025 Warrants under the Securities Act.
Pursuant to the January 2025 Securities Purchase Agreement, the Company is required to file a registration statement with the SEC within 45 days after the date of the January 2025 Securities Purchase Agreement to register the shares underlying the January 2025 Warrants under the Securities Act.
Pursuant to the January 2025 Securities Purchase Agreement, we were required to file a registration statement with the SEC within 45 days after the date of the January 2025 Securities Purchase Agreement to register the shares underlying the January 2025 Warrants under the Securities Act.
More details about the study can be found on the clinicaltrials.gov website. 36 Trial 3 will be a Phase II open label study utilizing commercially available Arakoda.
More details about the study can be found on the clinicaltrials.gov website. 31 Trial 3 is a Phase II open label study utilizing commercially available Arakoda.
The ARAKODA commercial pilot program will commence on March 17, 2025, with three main objectives: 1. Increase ARAKODA awareness and communicate ARAKODA’s value proposition. 2. Drive ARAKODA trial and usage and 3. Facilitate access and affordability. The pilot includes a three-pronged approach utilizing Virtual Sales Representatives (VSRs), a programmatic email campaign, and a co-pay offering for commercially insured patients.
The ARAKODA commercial pilot program commenced in Q1 2025, with three main objectives: 1. Increase ARAKODA awareness and communicate ARAKODA’s value proposition; 2. Drive ARAKODA trial and usage; and 3. Facilitate access and affordability. The pilot includes a three-pronged approach utilizing Virtual Sales Representatives (VSRs), a programmatic email campaign, and a co-pay offering for commercially insured patients.
Estimated/ Anticipated Expiration Date Regimens Of Tafenoquine For Prevention Of Malaria In Malaria-Naive Subjects 11,744,828 US 9/5/2023 17/145,530 02-Dec-2035 ^ Novel Regimens Of Tafenoquine For Prevention Of Malaria In Malaria-Naïve Subjects Pending New Zealand Pending 731813 02-Dec-2035* Regimens of Tafenoquine for Prevention of Malaria in Malaria-Naive Subjects Pending US Pending 18/240,049 02-Dec-2035 ^ Novel Dosing Regimens Of Celgosivir For The Prevention Of Dengue 2016368580 Australia 2016368580 09-Dec-2036* Novel Dosing Regimens Of Celgosivir For The Prevention Of Dengue Pending Singapore Pending 10201912141Y 09-Dec-2036* Dosing Regimens Of Celgosivir For The Prevention Of Dengue 11000516 US 5/11/2011 16/060,945 09-Dec-2036 ^ Methods For The Treatment And Prevention Of Lung Infections By Administration Of Tafenoquine Pending EP Pending 21764438.4 02-Mar-2041* Methods For The Treatment And Prevention Of Lung Infections By Administration Of Tafenoquine Pending China Pending 202180029643.7 02-Mar-2041* Methods For The Treatment And Prevention Of Lung Infections By Administration Of Tafenoquine Pending Australia Pending 2021231743 02-Mar-2041* Methods For The Treatment And Prevention Of Lung Infections Caused By Gram-Positive Bacteria, Fungus, Or Virus By Administration Of Tafenoquine Pending Hong Kong Pending 62023078645.6 02-Mar-2041* Methods For The Treatment And Prevention Of Lung Infections Caused By Gram-Positive Bacteria, Fungus, Or Virus By Administration Of Tafenoquine 11,633,391 US 4/25/2023 17/189,544 05-May-2041 ^ Methods For The Treatment And Prevention Of Lung Infections Caused By Gram-Positive Bacteria, Fungus, Or Virus By Administration Of Tafenoquine Pending US Pending 18/300,805 02-Mar-2041 ^ Methods For The Treatment And Prevention Of Lung Infections Caused By Fungus By Administration Of Tafenoquine Pending US Pending 17/683,679 02-Mar-2041 ^ Methods For The Treatment And Prevention Of Lung Infections Caused By Sars-Cov-2 Virus By Administration Of Tafenoquine Pending US Pending 17/683,718 02-Mar-2041 ^ 14 Title Patent No.
Estimated/ Anticipated Expiration Date Regimens Of Tafenoquine For Prevention Of Malaria In Mal2aria-Naive Subjects 11,744,828 US 9/5/2023 17/145,530 02-Dec-2035** Novel Regimens Of Tafenoquine For Prevention Of Malaria In Malaria-Naïve Subjects 731813 New Zealand 731813 02-Dec-2035* Regimens of Tafenoquine for Prevention of Malaria in Malaria-Naive Subjects Pending US Pending 18/240,049 02-Dec-2035** Novel Dosing Regimens Of Celgosivir For The Prevention Of Dengue 2016368580 Australia 2016368580 09-Dec-2036* Novel Dosing Regimens Of Celgosivir For The Prevention Of Dengue Pending Singapore Pending 10201912141Y 09-Dec-2036* Dosing Regimens Of Celgosivir For The Prevention Of Dengue 11000516 US 5/11/2021 16/060,945 09-Dec-2036** Methods For The Treatment And Prevention Of Lung Infections By Administration Of Tafenoquine Pending EP Pending 21764438.4 02-Mar-2041* Methods For Treating And Preventing Pulmonary Infections By Administering Tafenoquine Pending China Pending 202180029643.7 02-Mar-2041* Methods For The Treatment And Prevention Of Lung Infections Caused By Gram-Positive Bacteria, Fungus, Or Virus By Administration Of Tafenoquine 2021231743 Australia 2021231743 02-Mar-2041* Methods For The Treatment And Prevention Of Lung Infections Caused By Gram-Positive Bacteria, Fungus, Or Virus By Administration Of Tafenoquine Pending Hong Kong Pending 62023078645.6 02-Mar-2041* Methods For The Treatment And Prevention Of Lung Infections Caused By Gram-Positive Bacteria, Fungus, Or Virus By Administration Of Tafenoquine 11,633,391 US 4/25/2023 17/189,544 31-May-2041** Methods For The Treatment And Prevention Of Lung Infections Caused By Gram-Positive Bacteria, Fungus, Or Virus By Administration Of Tafenoquine Pending US Pending 18/300,805 02-Mar-2041** Methods For The Treatment And Prevention Of Lung Infections Caused By Fungus By Administration Of Tafenoquine 12383546 US 8/12/2025 17/683,679 02-Mar-2041** Methods For The Treatment And Prevention Of Lung Infections Caused By Sars-Cov-2 Virus By Administration Of Tafenoquine Pending US Pending 17/683,718 02-Mar-2041** Methods For The Treatment And Prevention Of Lung Infections Caused By Fungus By Administration Of Tafenoquine Pending US Pending 19/294531 02-Mar-2041** 15 Title Patent No.
When a foreign clinical study is conducted under an IND, all FDA IND requirements must be met unless waived. When the foreign clinical study is not conducted under an IND, the sponsor must ensure that the study complies with certain FDA requirements in order to use the study as support for an IND or application for marketing approval.
When the foreign clinical study is not conducted under an IND, the sponsor must ensure that the study complies with certain FDA requirements in order to use the study as support for an IND or application for marketing approval.
In a concurrent private placement, the Company also issued to the February 2025 Purchasers unregistered warrants (the “February 2025 Warrants”) to purchase up to an aggregate of 300,700 shares of common stock at an exercise price of $2.95 per share. The February 2025 Warrants are exercisable upon issuance and expire twenty-four months from the date of issuance.
In a concurrent private placement, the Company also issued to the February 2025 Purchasers unregistered warrants (the “February 2025 Warrants”) to purchase up to an aggregate of 75,176 shares of common stock at an exercise price of $ 11.80 per share. The February 2025 Warrants are exercisable upon issuance and expire twenty-four months from the date of issuance.
In a concurrent private placement, the Company also issued to the January 2025 Purchasers unregistered warrants (the “January 2025 Warrants”) to purchase up to an aggregate of 408,621 shares of common stock at an exercise price of $3.855 per share. The January 2025 Warrants are exercisable upon issuance and expire twenty-four months from the date of issuance.
In a concurrent private placement, the Company also issued to the January 2025 Purchasers unregistered warrants (the “January 2025 Warrants”) to purchase up to an aggregate of 102,158 shares of common stock at an exercise price of $ 15.42 per share. The January 2025 Warrants are exercisable upon issuance and expire twenty-four months from the date of issuance.
In connection with the Private Placement, we issued to Wainwright the Placement Agent Warrants to purchase 43,479 shares of our Common Stock. The Placement Agent Warrants have an exercise price equal to $8.625 per share and are exercisable beginning on the effective date of Stockholder Approval for five years from Stockholder Approval.
In connection with the Private Placement, we issued to Wainwright the Placement Agent Warrants to purchase 10,870 shares of our Common Stock. The Placement Agent Warrants have an exercise price equal to $ 34.50 per share and are exercisable beginning on the effective date of Stockholder Approval for five years from Stockholder Approval.
We will be required to make a minimum annual royalty payment of 3% of net sales for net sales On September 15, 2016, we entered into the Exclusive License Agreement (the “2016 NUS-SHS Agreement”) with National University of Singapore (“NUS”) and Singapore Health Services Pte Ltd (“SHS”) in which we were granted a license from NUS and SHS with respect to their share of patent rights regarding “Novel Dosing Regimens of Celgosivir for The Prevention of Dengue” to develop, market and sell licensed products.
On September 15, 2016, we entered into the Exclusive License Agreement (the “2016 NUS-SHS Agreement”) with National University of Singapore (“NUS”) and Singapore Health Services Pte Ltd (“SHS”) in which we were granted a license from NUS and SHS with respect to their share of patent rights regarding “Novel Dosing Regimens of Celgosivir for The Prevention of Dengue” to develop, market and sell licensed products.
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 who have experienced severe fatigue with significant functional impairment for at least six months upon enrollment. Patient enrollment is expected to begin in Q3 2025.
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 who have experienced severe fatigue with significant functional impairment for at least six months upon enrollment. The first patient was enrolled in Q4 2025.
Additionally, we kicked off a market assessment on the babesiosis space including desk top research and qualitative interviews with Key Opinion Leaders in the Infectious Disease and Lyme Community. We plan to initiate quantitative research in Q2 2025 to assess the market opportunity for a potential development program for Chronic Babesiosis.
Additionally, we kicked off a market assessment on the babesiosis space including desk top research and qualitative interviews with Key Opinion Leaders in the Infectious Disease and Lyme Community. In 2025 we conducted quantitative research with Healthcare Providers and consumers to assess the market opportunity for the Chronic Babesiosis development program.
Currently, 60P’s pipeline under development covers development programs for vector-borne, fungal, and viral diseases utilizing three of the Company’s future products: (i) new products that contain the Arakoda regimen of Tafenoquine; (ii) new products that contain Tafenoquine; and (iii) Celgosivir.
Currently, 60P’s pipeline under development covers development programs for vector-borne, fungal, and viral diseases utilizing three of the Company’s future products: (i) new products that contain the Arakoda regimen of Tafenoquine; (ii) new products that contain Tafenoquine; and (iii) Celgosivir and/or botanical extracts from Australian Chestnut Trees.
After deduction of a 5% administrative fee by FSURF, capped at $15,000 annually, and reimbursement of patent prosecution expenses, we will receive 20% of license income and FSURF will receive 80% of license income. Payments of license income shall be paid in U.S. dollars quarterly each year.
The term of the FSURF Agreement expires five years from February 15, 2021. After deduction of a 5% administrative fee by FSURF, capped at $15,000 annually, and reimbursement of patent prosecution expenses, we will receive 20% of license income and FSURF will receive 80% of license income. Payments of license income shall be paid in U.S. dollars quarterly each year.
On June 1, 2022, 60 Degrees Pharmaceuticals, LLC, a District of Columbia limited liability company (“60P LLC”), entered into the Agreement and Plan of Merger with 60 Degrees Pharmaceuticals, Inc., pursuant to which 60P LLC merged into 60 Degrees Pharmaceuticals, Inc.
Corporate History 60 Degrees Pharmaceuticals, Inc. is a Delaware corporation that was incorporated on June 1, 2022. On June 1, 2022, 60 Degrees Pharmaceuticals, LLC, a District of Columbia limited liability company (“60P LLC”), entered into the Agreement and Plan of Merger with 60 Degrees Pharmaceuticals, Inc., pursuant to which 60P LLC merged into 60 Degrees Pharmaceuticals, Inc.
We own 97% equity in 60P Australia Pty Ltd, a Sydney-Australia based subsidiary (“60P Australia”). 60P Australia holds sub-licensing rights for several ex-U.S. territories for our product. 60P Australia previously solely owned a Singaporean subsidiary company, 60P Singapore Pte.
We own 97% equity in 60P Australia Pty Ltd, a Sydney, Australia-based subsidiary (“60P Australia”). 60P Australia holds sub-licensing rights for several ex-U.S. territories for our product. 60P Australia previously solely owned a Singaporean subsidiary company, 60P Singapore Pte. Ltd., which dissolved at our election in the second quarter of 2022.
The total number of shares that remain available for issuance under the 2022 Plan is 57,068 shares effective as of March 27, 2025, which additional reservation of shares provides us with flexibility to address future equity compensation needs.
The total number of shares that remain available for issuance under the 2022 Plan is 115,284 shares effective as of March 30, 2026 , which additional reservation of shares provides us with flexibility to address future equity compensation needs.
To obtain approval of a generic drug, an applicant must submit an ANDA to the agency. In support of such applications, a generic manufacturer may rely on the preclinical and clinical testing previously conducted for a drug product previously approved under an NDA, known as the reference-listed drug (“RLD”).
In support of such applications, a generic manufacturer may rely on the preclinical and clinical testing previously conducted for a drug product previously approved under an NDA, known as the reference-listed drug (“RLD”).
Amendments to 2022 Equity Incentive Plan On July 16, 2024 and November 6, 2024, our stockholders approved an amendment to the 60 Degrees Pharmaceuticals, Inc. 2022 Equity Incentive Plan (the “2022 Plan”) to increase the number of shares of Common Stock authorized for issuance by 83,334 shares and 100,000 shares, respectively, which were previously approved by the Board.
Amendments to 2022 Equity Incentive Plan On July 16, 2024, November 6, 2024, and October 8, 2025, our stockholders approved an amendment to the 60 Degrees Pharmaceuticals, Inc. 2022 Equity Incentive Plan (the “2022 Plan”) to increase the number of shares of Common Stock authorized for issuance by 20,834 shares, 25,000 shares, and 62,500 shares, respectively, which were previously approved by the Board.
In May 2024, we signed a research and collaboration agreement with North Carolina State University in which the College of Veterinary Medicine will screen archived blood samples from 50 patients exhibiting symptoms consistent with chronic fatigue symptoms by PCR for the presence of Babesia spp by digital PCR and DNA sequencing.
More details about the study can be found on the clinicaltrials.gov website. 32 In May 2024, we signed a research and collaboration agreement with North Carolina State University in which the College of Veterinary Medicine will screen archived blood samples from 50 patients exhibiting symptoms consistent with chronic fatigue by PCR for the presence of Babesia spp by digital PCR and DNA sequencing.
Secondary objectives include assessing confirmable Babesia infection rates in these populations using validated molecular assays, and assessing the safety and tolerability profile of Arakoda in this patient population.
Secondary objectives include assessing confirmable Babesia infection rates in these populations using validated molecular assays, and assessing the safety and tolerability profile of Arakoda in this patient population. As of the date of this filing, three patients were enrolled.
This does not account for possible Patent Term Adjustment (PTA), Patent Term Extension (PTE), or Terminal Disclaimers. + = 60 Degrees Pharmaceuticals, Inc. is not a listed Applicant and Geoffrey S. Dow, Ph.D. is not a listed inventor. # = 60 Degrees Pharmaceuticals, Inc. is not a listed Applicant, but Geoffrey S. Dow, Ph.D. is a listed inventor.
This does not account for possible Patent Term Adjustment (PTA), Patent Term Extension (PTE), or Terminal Disclaimers. + = 60 Degrees Pharmaceuticals, Inc. is not a listed Applicant and Geoffrey S. Dow, Ph.D. is not a listed inventor. All patents not designated with a “+” list Geoffrey S. Dow, Ph.D. as an inventor.
Specifically, the applicant must certify with respect to each patent that: ● the required patent information has not been filed; ● the listed patent has expired; ● the listed patent has not expired, but will expire on a particular date and approval is sought after patent expiration; or ● the listed patent is invalid, unenforceable or will not be infringed by the new product.
Specifically, the applicant must certify with respect to each patent that: the required patent information has not been filed; the listed patent has expired; the listed patent has not expired, but will expire on a particular date and approval is sought after patent expiration; or the listed patent is invalid, unenforceable or will not be infringed by the new product. 27 A certification that the new product will not infringe the already approved product’s listed patents or that such patents are invalid or unenforceable is called a Paragraph IV certification.
(JAMA 1996;275:1657-16602) who reported that 10% of Lyme disease patients are co-infected with babesiosis and that according to Krause et al (AJTMH 2003;6:431-436) fact that about 80% of cases are symptomatic (thus 476,000*10%*80% = 38,000 cases of babesiosis per year). 10 Bloch et al Open Forum Infect Dis 2022;9(11):ofac597. 11 According to IDSA guidelines. 12 See Krause et al Clin Infect Dis 2024; doi:10.1093/cid/ciae238 and https://ysph.yale.edu/news-article/antimalarial-drug-is-effective-against-tick-borne-infection-babesiosis/. 6 ● Prevention of Tick-Borne Diseases .
(JAMA 1996;275:1657-16602) who reported that 10% of Lyme disease patients are co-infected with babesiosis and that according to Ssentongo et al ( Open Forum Infect Dis 2024 Oct 8;11(10):ofae504.doi:10.1093), approximately 40% of acute babesiosis patients are coinfected with Lyme disease (thus 476,000*10%/40% = 119,000 cases of babesiosis per year). 10 Bloch et al Open Forum Infect Dis 2022;9(11):ofac597. 11 According to IDSA guidelines. 12 See Krause et al Clin Infect Dis 2024; doi:10.1093/cid/ciae238 and https://ysph.yale.edu/news-article/antimalarial-drug-is-effective-against-tick-borne-infection-babesiosis/. 7 Prevention of Tick-Borne Diseases .

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Item 1C. Cybersecurity

Cybersecurity — threats and controls disclosure

5 edited+2 added−1 removed4 unchanged
Biggest changeThe updates will be provided at least annually, or more frequently as needed, to ensure cybersecurity risks are appropriately managed and integrated into our broader risk oversight strategy. Despite our efforts to improve our cybersecurity measures, there can be no assurance that our initiatives will fully mitigate the risks posed by cyber threats.
Biggest changeThe Board (or designated committee or officer) will receive periodic updates on cybersecurity risks, including emerging threats, mitigation efforts and incident response activities. The updates will be provided at least annually, or more frequently as needed, to ensure cybersecurity risks are appropriately managed and integrated into our broader risk oversight strategy.
In addition, cybersecurity incidents could have material adverse effects on our business strategy, financial condition, and results of operations (e.g., a significant breach could result in direct financial losses due to fraud, system downtime impacting revenue generation, increased compliance costs or contractual liabilities with third-party vendors and customers). 39 We are in the process of evaluating our cybersecurity needs and developing appropriate measures to enhance our cybersecurity posture.
In addition, cybersecurity incidents could have material adverse effects on our business strategy, financial condition, and results of operations (e.g., a significant breach could result in direct financial losses due to fraud, system downtime impacting revenue generation, increased compliance costs or contractual liabilities with third-party vendors and customers).
For a discussion of potential cybersecurity risks affecting us, please refer to the “Risk Factors” section of our Registration Statement on Form S-1 filed with the Securities and Exchange Commission on February 14, 2025 titled “ Cybersecurity risks could adversely affect our business and disrupt our operations .”
The landscape of cybersecurity risks is constantly evolving, and we will continue to assess and update our cybersecurity measures in response to emerging threats For a discussion of potential cybersecurity risks affecting us, please refer to the “Risk Factors” section of our Registration Statement on Form S-1 filed with the Securities and Exchange Commission on February 14, 2025 titled “ Cybersecurity risks could adversely affect our business and disrupt our operations .”
In addition, the Board will oversee any cybersecurity risk management framework and a dedicated committee of the Board or an officer appointed by the Board will review and approve any cybersecurity policies, strategies and risk management practices. The Board (or designated committee or officer) will receive periodic updates on cybersecurity risks, including emerging threats, mitigation efforts and incident response activities.
In addition, the Board will oversee any cybersecurity risk management framework and a dedicated committee of the Board or an officer appointed by the Board will review and approve any cybersecurity policies, strategies and risk management practices .
This includes considering the engagement of external cybersecurity experts to advise on best practices, conducting vulnerability assessments and developing an incident response strategy. Our goal is to establish a cybersecurity framework that is commensurate with our size, complexity and the nature of our operations, thereby reducing our exposure to cybersecurity risks.
Our goal is to establish a cybersecurity framework that is commensurate with our size, complexity and the nature of our operations, thereby reducing our exposure to cybersecurity risks.
Removed
The landscape of cybersecurity risks is constantly evolving, and we will continue to assess and update our cybersecurity measures in response to emerging threats.
Added
We are in the process of evaluating our cybersecurity needs and developing appropriate measures to enhance our cybersecurity posture. This includes considering the engagement of external cybersecurity experts to advise on best practices, conducting vulnerability assessments and developing an incident response strategy.
Added
Despite our efforts to improve our cybersecurity measures, there can be no assurance that our initiatives will fully mitigate the risks posed by cyber threats.

Item 2. Properties

Properties — owned and leased real estate

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Biggest changeItem 2. Properties. Our corporate headquarters are located at 1025 Connecticut Avenue NW Suite 1000, Washington, D.C. 20036. We do not own any physical property, plant or labs. We currently lease one office at the above address and in December 2024, we renewed our lease for an additional one-year term that expires March 31, 2026.
Biggest changeItem 2. Properties. Our corporate headquarters are located at 1025 Connecticut Avenue NW Suite 1000, Washington, D.C. 20036. We do not own any physical property, plant or labs. We currently lease one office at the above address, which lease was recently renewed for an additional one-year term expiring on March 31, 2027.

Item 3. Legal Proceedings

Legal Proceedings — active lawsuits and investigations

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Biggest changeRegardless of the outcome, litigation can have an adverse impact on us because of defense and settlement costs, diversion of management resources and other factors. Item 4. Mine Safety Disclosures. Not applicable. 40 PART II
Biggest changeRegardless of the outcome, litigation can have an adverse impact on us because of defense and settlement costs, diversion of management resources and other factors.

Other SXTP 10-K year-over-year comparisons