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What changed in 60 DEGREES PHARMACEUTICALS, INC.'s 10-K — 2023 vs 2024

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Paragraph-level year-over-year comparison of 60 DEGREES PHARMACEUTICALS, INC.'s 2023 and 2024 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 2024 report.

+394 added−303 removedSource: 10-K (2025-03-27) vs 10-K (2024-04-01)

Top changes in 60 DEGREES PHARMACEUTICALS, INC.'s 2024 10-K

394 paragraphs added · 303 removed · 177 edited across 6 sections

Item 1. Business

Business — how the company describes what it does

98 edited+119 added−69 removed265 unchanged
Biggest changeEstimated/ 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* 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* 11 Title Patent No.
Biggest changeEstimated/ 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.
Preliminary data suggest Celgosivir inhibits the replication of the virus that causes COVID-19 (SARS-CoV-2) in cell culture, and the RSV virus in cell culture and provides benefits in animals.
Preliminary data suggest that Celgosivir inhibits the replication of the virus that causes COVID-19 (SARS-CoV-2) in cell culture, and the RSV virus in cell culture and provides benefits in animals.
The FDA’s position was somewhat surprising given that neither Paxlovid nor Lagevrio is indicated for treatment of COVID-19 in low-risk patients. We determined that conducting our study in an alternate population in the United States would be unfeasible, and conducting an add-on-to standard of care study might not be Phase III enabling.
The FDA’s position was somewhat surprising given that neither Paxlovid nor Lagevrio is indicated for treatment of COVID-19 in low-risk patients. We determined that conducting our study in an alternate population in the United States would be unfeasible, and that conducting an add-on-to standard of care study might not be Phase III enabling.
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.
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.
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.
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; 34 ● 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; 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.
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; 35 ● 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; 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.
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. 17 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. 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.
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. 19 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. 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.
In January 2017, President Trump signed an Executive Order directing federal agencies with authorities and responsibilities under the ACA to waive, defer, grant exemptions from, or delay the implementation of any provision of the ACA that would impose a fiscal or regulatory burden on states, individuals, healthcare providers, health insurers, or manufacturers of pharmaceuticals or medical devices.
Previously in January 2017, President Trump signed an Executive Order directing federal agencies with authorities and responsibilities under the ACA to waive, defer, grant exemptions from, or delay the implementation of any provision of the ACA that would impose a fiscal or regulatory burden on states, individuals, healthcare providers, health insurers, or manufacturers of pharmaceuticals or medical devices.
(“KTI”), completed Phase IIA studies in P. vivax malaria, in which they evaluated the safety and efficacy of SJ733, their ATP4 inhibitor in combination with Tafenoquine as the combination partner drug. Recently it was announced the SJ733 development program would be partially supported by a grant from the Global Health Innovative Technology Fund (“GHIT”).
(“KTI”), completed Phase IIA studies in P. vivax malaria, in which they evaluated the safety and efficacy of SJ733, their ATP4 inhibitor in combination with Tafenoquine as the combination partner drug. It was recently announced that the SJ733 development program would be partially supported by a grant from the Global Health Innovative Technology Fund (“GHIT”).
The FDA may take certain actions with respect to breakthrough therapies, including holding meetings with the sponsor throughout the development process; providing timely advice to the product sponsor regarding development and approval; involving more senior staff in the review process; assigning a cross-disciplinary project lead for the review team; and taking other steps to design the clinical trials in an efficient manner. 21 Third, the FDA may designate a product for priority review if it is a product that treats a serious condition and, if approved, would provide a significant improvement in safety or effectiveness.
The FDA may take certain actions with respect to breakthrough therapies, including holding meetings with the sponsor throughout the development process; providing timely advice to the product sponsor regarding development and approval; involving more senior staff in the review process; assigning a cross-disciplinary project lead for the review team; and taking other steps to design the clinical trials in an efficient manner. 23 Third, the FDA may designate a product for priority review if it is a product that treats a serious condition and, if approved, would provide a significant improvement in safety or effectiveness.
Should this collaboration be successful, we believe that the data from that study may provide supportive data for the clinical babesiosis development program, and could provide proof of concept for an expanded study to prove utility for veterinary indications.
Should this potential collaboration be successful, we believe that the data from that study may provide supportive data for the clinical babesiosis development program, and could provide proof of concept for an expanded study to prove utility for veterinary indications.
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. 28 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. 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.
In October 2017, the President signed a second Executive Order allowing for the use of association health plans and short-term health insurance, which may provide fewer health benefits than the plans sold through the ACA exchanges.
In October 2017, President Trump signed a second Executive Order allowing for the use of association health plans and short-term health insurance, which may provide fewer health benefits than the plans sold through the ACA exchanges.
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. 29 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. 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.
As defined by the statute, tropical diseases refer to certain “infectious disease[s] for which there is no significant market in developed nations and that disproportionately affects poor and marginalized populations.” 29 Because tropical diseases occur rarely in the United States, obtaining approval from the FDA for treating these diseases would normally be unprofitable for pharmaceutical companies due to the limited domestic market and the scope and significant financial costs of the post-marketing requirements imposed by FDA.
As defined by the statute, tropical diseases refer to certain “infectious disease[s] for which there is no significant market in developed nations and that disproportionately affects poor and marginalized populations.” 41 Because tropical diseases occur rarely in the United States, obtaining approval from the FDA for treating these diseases would normally be unprofitable for pharmaceutical companies due to the limited domestic market and the scope and significant financial costs of the post-marketing requirements imposed by FDA.
The PDMA, its implementing regulations and state laws limit the distribution of prescription pharmaceutical product samples, and the DSCSA imposes requirements to ensure accountability in distribution and to identify and remove counterfeit and other illegitimate products from the market. 24 Abbreviated New Drug Applications for Generic Drugs In 1984, with passage of the Hatch-Waxman Amendments to the FDCA, Congress authorized the FDA to approve generic drugs that are the same as drugs previously approved by the FDA under the NDA provisions of the statute.
The PDMA, its implementing regulations and state laws limit the distribution of prescription pharmaceutical product samples, and the DSCSA imposes requirements to ensure accountability in distribution and to identify and remove counterfeit and other illegitimate products from the market. 26 Abbreviated New Drug Applications for Generic Drugs In 1984, with passage of the Hatch-Waxman Amendments to the FDCA, Congress authorized the FDA to approve generic drugs that are the same as drugs previously approved by the FDA under the NDA provisions of the statute.
There also are continuing, annual user fee requirements for any marketed products and the establishments at which such products are manufactured, as well as new application fees for supplemental applications with clinical data. 23 In addition, drug manufacturers and other entities involved in the manufacture and distribution of approved drugs are required to register their establishments with the FDA and state agencies, and are subject to periodic unannounced inspections by the FDA and these state agencies for compliance with cGMP requirements.
There also are continuing, annual user fee requirements for any marketed products and the establishments at which such products are manufactured, as well as new application fees for supplemental applications with clinical data. 25 In addition, drug manufacturers and other entities involved in the manufacture and distribution of approved drugs are required to register their establishments with the FDA and state agencies, and are subject to periodic unannounced inspections by the FDA and these state agencies for compliance with cGMP requirements.
The new legislation also authorizes the FDA to expedite review of “competitor generic therapies” or drugs with inadequate generic competition, including holding meetings with or providing advice to the drug sponsor prior to submission of the application. 25 Hatch-Waxman Patent Certification and the 30-Month Stay Upon approval of an NDA or a supplement thereto, NDA sponsors are required to list with the FDA each patent with claims that cover the applicant’s product or an approved method of using the product.
The new legislation also authorizes the FDA to expedite review of “competitor generic therapies” or drugs with inadequate generic competition, including holding meetings with or providing advice to the drug sponsor prior to submission of the application. 27 Hatch-Waxman Patent Certification and the 30-Month Stay Upon approval of an NDA or a supplement thereto, NDA sponsors are required to list with the FDA each patent with claims that cover the applicant’s product or an approved method of using the product.
Third-party payors may limit coverage to specific products on an approved list, or formulary, which might not include all of the approved products for a particular indication. 33 In order to secure coverage and reimbursement for any product that might be approved for sale, a company may need to conduct expensive pharmacoeconomic studies in order to demonstrate the medical necessity and cost-effectiveness of the product, in addition to the costs required to obtain FDA or other comparable regulatory approvals.
Third-party payors may limit coverage to specific products on an approved list, or formulary, which might not include all of the approved products for a particular indication. 35 In order to secure coverage and reimbursement for any product that might be approved for sale, a company may need to conduct expensive pharmacoeconomic studies in order to demonstrate the medical necessity and cost-effectiveness of the product, in addition to the costs required to obtain FDA or other comparable regulatory approvals.
In March 2010, the United States Congress enacted the Affordable Care Act, which, among other things, includes changes to the coverage and payment for drug products under government health care programs.
In March 2010, the United States Congress enacted the Affordable Care Act (the “ACA”), which, among other things, includes changes to the coverage and payment for drug products under government health care programs.
For example, Rhythm Pharmaceutical, Inc. announced in 2021 that it had sold a PRV for $100,000,000. 30 Accelerated Approval Pathway The FDA may grant accelerated approval to a drug for a serious or life-threatening condition that provides meaningful therapeutic advantage to patients over existing treatments based upon a determination that the drug has an effect on a surrogate endpoint that is reasonably likely to predict clinical benefit.
For example, Rhythm Pharmaceutical, Inc. announced in 2021 that it had sold a PRV for $100,000,000. 42 Accelerated Approval Pathway The FDA may grant accelerated approval to a drug for a serious or life-threatening condition that provides meaningful therapeutic advantage to patients over existing treatments based upon a determination that the drug has an effect on a surrogate endpoint that is reasonably likely to predict clinical benefit.
This was a consequence of advice previously received from the FDA, which we interpreted to mean that they would not have granted clearance for the study to proceed unless we redesigned it to (i) enroll a patient population in which receipt of Paxlovid or Lagevrio would be medically contraindicated or (ii) compare Tafenoquine to placebo in patients taking a “standard of care” regimen (defined by the FDA as Lagevrio or Paxlovid).
This was a consequence of advice previously received from the FDA, which we interpreted to mean that the Agency would not have granted clearance for the study to proceed unless we redesigned it to (i) enroll a patient population in which receipt of Paxlovid or Lagevrio would be medically contraindicated, or (ii) compare Tafenoquine to placebo in patients taking a “standard of care” regimen (defined by the FDA as Lagevrio or Paxlovid).
Tier 3). However, generic-atovaquone proguanil does not provide the same level of confidence a traveler may experience from taking a product with a convenient weekly dosing regimen during travel, that works everywhere in the world against all malaria species and drug resistant strains, and which requires only a single dose for post-exposure prophylaxis upon return from a malarious area.
However, generic-atovaquone proguanil does not provide the same level of confidence a traveler may experience from taking a product with a convenient weekly dosing regimen during travel, that works everywhere in the world against all malaria species and drug-resistant strains, and which requires only a single dose for post-exposure prophylaxis upon return from a malarious area.
Regulatory approval in one country or jurisdiction does not ensure regulatory approval in another, but a failure or delay in obtaining regulatory approval in one country or jurisdiction may negatively impact the regulatory process in others. 30 Periods of Authorization and Renewals Marketing authorization is valid for five years in principle and the marketing authorization may be renewed after five years on the basis of a re-evaluation of the risk-benefit balance by the EMA or by the competent authority of the authorizing member state.
Regulatory approval in one country or jurisdiction does not ensure regulatory approval in another, but a failure or delay in obtaining regulatory approval in one country or jurisdiction may negatively impact the regulatory process in others. 32 Periods of Authorization and Renewals Marketing authorization is valid for five years in principle and the marketing authorization may be renewed after five years on the basis of a re-evaluation of the risk-benefit balance by the EMA or by the competent authority of the authorizing member state.
Under Section 28D of the Industry Research and Development Act 1986 27 , research and development activities conducted outside Australia are also potentially eligible if they meet the following criteria: (i) they are approved in advance, (ii) they are linked to a core research and development activity conducted in Australia, (iii) cannot be conducted in Australia for various reasons and (iv) the value of activities conducted overseas is less than the value of activities conducted in Australia.
Under Section 28D of the Industry Research and Development Act 1986 39 , research and development activities conducted outside Australia are also potentially eligible if they meet the following criteria: (i) they are approved in advance, (ii) they are linked to a core research and development activity conducted in Australia, (iii) cannot be conducted in Australia for various reasons and (iv) the value of activities conducted overseas is less than the value of activities conducted in Australia.
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 $5.00 per share. We also operate one subsidiary. A summary of our majority-owned subsidiary is below.
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.
Unless otherwise required by regulation, the pediatric data requirements do not apply to products with orphan designation. 26 Pediatric exclusivity is another type of non-patent marketing exclusivity in the United States and, if granted, provides for the attachment of an additional six months of marketing protection to the term of any existing regulatory exclusivity, including the non-patent and orphan exclusivity.
Unless otherwise required by regulation, the pediatric data requirements do not apply to products with orphan designation. 28 Pediatric exclusivity is another type of non-patent marketing exclusivity in the United States and, if granted, provides for the attachment of an additional six months of marketing protection to the term of any existing regulatory exclusivity, including the non-patent and orphan exclusivity.
Registration ● Sponsor applies to register the product on the Australian Register of Therapeutic Goods. ● Supply is permitted once the applicable number is allocated. 32 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. 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.
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. 20 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. 22 Before approving an NDA, the FDA typically will inspect the facility or facilities where the product is or will be manufactured.
We, and the NIH, found that Tafenoquine exhibits a Broad Spectrum of Activity in cell culture against Candida and other yeast strains via a different Mode of Action than traditional antifungals and also exhibits antifungal activity against some fungal strains at clinically relevant doses in animal models. 17 Our work followed Legacy Studies that show Tafenoquine is effective for treatment and prevention of Pneumocystis pneumonia in animal models. 18 We believe that if added to the standard of care for anti-fungal and yeast infection treatments for general use, Tafenoquine has the potential to improve patient outcomes in terms of recovery from yeast infections, and prevention of fungal pneumonias in immunosuppressed patients.
We, and the NIH, found that Tafenoquine exhibits a Broad Spectrum of Activity in cell culture against Candida and other yeast strains via a different Mode of Action than traditional antifungals and also exhibits antifungal activity against some fungal strains at clinically relevant doses in animal models. 26 Our work followed Legacy Studies that show Tafenoquine is effective for treatment and prevention of Pneumocystis pneumonia in animal models. 27 We believe that if added to the standard of care for anti-fungal and yeast infection treatments for general use, Tafenoquine has the potential to improve patient outcomes in terms of recovery from yeast infections, and prevention of fungal pneumonias in immunosuppressed patients.
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. 21 Celgosivir (as with other Dengue antivirals) exhibits greater capacity to cure Dengue infections in animal models when administered prior to symptom onset compared to 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. 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.
The FDA will base that determination on information provided by the sponsor correcting the deficiencies previously cited or otherwise satisfying the FDA that the investigation can proceed. 18 A sponsor may choose, but is not required, to conduct a foreign clinical study under an IND.
The FDA will base that determination on information provided by the sponsor correcting the deficiencies previously cited or otherwise satisfying the FDA that the investigation can proceed. 20 A sponsor may choose, but is not required, to conduct a foreign clinical study under an IND.
When a drug application is designated for priority review through use of a priority review voucher, that application must be reviewed by FDA no later than 6 months after receipt. 28 This guarantees a much more rapid review by FDA compared to the standard review time.
When a drug application is designated for priority review through use of a priority review voucher, that application must be reviewed by FDA no later than 6 months after receipt. 40 This guarantees a much more rapid review by FDA compared to the standard review time.
Thus, an individual bitten by a tick cannot know whether they have also been infected with babesiosis. It is likely that a drug proven to be effective for this indication for babesiosis would also be used in conjunction with Lyme prophylaxis.
Thus, an individual bitten by a tick cannot know whether they have also been infected with babesiosis. It is likely that a drug proven to be effective for this indication for babesiosis would also be used in conjunction with Lyme prophylaxis. ● Veterinary Indications .
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. 25 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 early 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. 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.
Separately from the clinical indication, based on estimates from industry experts, there may be somewhere between several hundred and several thousand cases of canine babesiosis each year in the United States, and thousands more globally. Currently, standard of care treatment for babesiosis in dogs is a ten-day course of atovaquone and azithromycin, which costs about $1,350 out of pocket.
Based on estimates from industry experts, there may be somewhere between several hundred and several thousand cases of canine babesiosis each year in the United States, and thousands more globally. Currently, standard of care treatment for babesiosis in dogs is a ten-day course of atovaquone and azithromycin, which costs about $1,350 out of pocket.
Australian Research Tax Credit and Overseas Finding Process Under Section 27 of the Industry Research and Development Act 1986 26 , the Australian government offers a research tax credit of 43.5% on registered research and development activities executed in Australia by eligible Australian domiciled entities.
Australian Research Tax Credit and Overseas Finding Process Under Section 27 of the Industry Research and Development Act 1986 38 , the Australian government offers a research tax credit of 43.5% on registered research and development activities executed in Australia by eligible Australian domiciled entities.
Patent and Trademark Office reviews and approves the application for any patent term extension or restoration in consultation with the FDA. 27 Review and Approval of Medical Devices in the United States Medical devices in the United States are strictly regulated by the FDA.
Patent and Trademark Office reviews and approves the application for any patent term extension or restoration in consultation with the FDA. 29 Review and Approval of Medical Devices in the United States Medical devices in the United States are strictly regulated by the FDA.
The processes for obtaining regulatory approvals in the United States and in foreign countries and jurisdictions, along with subsequent compliance with applicable statutes and regulations and other regulatory authorities, require the expenditure of substantial time and financial resources. 26 See Industry Research and Development Act 1986 (legislation.gov.au). 27 See Australian Government R&D Tax Incentive – Overseas R&D: Information Sheet. 16 Review and Approval of Drugs in the United States In the United States, the FDA regulates, among other things, the research, development, testing, manufacturing, approval, labeling, storage, recordkeeping, advertising, promotion and marketing, distribution, post approval monitoring and reporting and import and export of drugs in the U.S. to assure the safety and effectiveness of medical products for their intended use under the Federal Food, Drug, and Cosmetic Act (“FDCA”), and implementing regulations.
The processes for obtaining regulatory approvals in the United States and in foreign countries and jurisdictions, along with subsequent compliance with applicable statutes and regulations and other regulatory authorities, require the expenditure of substantial time and financial resources. 38 See Industry Research and Development Act 1986 (legislation.gov.au). 39 See Australian Government R&D Tax Incentive - Overseas R&D: Information Sheet. 18 Review and Approval of Drugs in the United States In the United States, the FDA regulates, among other things, the research, development, testing, manufacturing, approval, labeling, storage, recordkeeping, advertising, promotion and marketing, distribution, post approval monitoring and reporting and import and export of drugs in the U.S. to assure the safety and effectiveness of medical products for their intended use under the Federal Food, Drug, and Cosmetic Act (“FDCA”), and implementing regulations.
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. 12 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. 21 With the U.S.
This estimate is based on the observation that approximately 50,000 tick bites are treated in U.S. hospital emergency rooms each year but this calculation represents only about 12% of actual treated tick bites based on observations from comparable ex-U.S health systems. 5 Unlike Lyme disease, there is no characteristic rash associated with early infection, and no reliable diagnostic tests.
This estimate is based on the observation that approximately 50,000 tick bites are treated in U.S. hospital emergency rooms each year; however, this calculation represents only about 12% of actual treated tick bites based on observations from comparable ex-U.S health systems. 13 Unlike Lyme disease, there is no characteristic rash associated with early infection and no reliable diagnostic tests.
Drugs granted accelerated approval must meet the same statutory standards for safety and effectiveness as those granted traditional approval. 28 21 U.S.C. § 360n(a)(1). 29 21 U.S.C. § 360n(a)(3). 30 Ben Adams, Newly acquired Alexion pays $100M for Rhythm’s speedy review voucher , Fierce Biotech (Jan 6, 2021, 10:23 AM), available at https://www.fiercebiotech.com/biotech/newly-acquired-alexion-pays-100m-for-rhythm-s-speedy-review-voucher. 22 For the purposes of accelerated approval, a surrogate endpoint is a marker, such as a laboratory measurement, radiographic image, physical sign or other measure that is thought to predict clinical benefit, but is not itself a measure of clinical benefit.
Drugs granted accelerated approval must meet the same statutory standards for safety and effectiveness as those granted traditional approval. 40 21 U.S.C. § 360n(a)(1). 41 21 U.S.C. § 360n(a)(3). 42 Ben Adams, Newly acquired Alexion pays $100M for Rhythm’s speedy review voucher , Fierce Biotech (Jan 6, 2021, 10:23 AM), available at https://www.fiercebiotech.com/biotech/newly-acquired-alexion-pays-100m-for-rhythm-s-speedy-review-voucher. 24 For the purposes of accelerated approval, a surrogate endpoint is a marker, such as a laboratory measurement, radiographic image, physical sign or other measure that is thought to predict clinical benefit, but is not itself a measure of clinical benefit.
The features and benefits of Tafenoquine for malaria prophylaxis (marketed as Arakoda in the United States), 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. 14 Tafenoquine entered the commercial supply chains in the U.S.
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.
On August 19, 2021, we entered into an agreement with FSURF, subsequently amended on February 15, 2023, that collectively granted an option, effective through August 19, 2023, to us to license a patent relating to the use of alpha glucosidase inhibitors (including Castanospermine and Celgosivir) for treatment of Zika infections.
On August 19, 2021, we entered into an agreement with FSURF, subsequently amended on February 15, 2023, and effective on March 24, 2025, that collectively granted an option, effective through March 23, 2026, to us to license a patent relating to the use of alpha glucosidase inhibitors (including castanospermine and Celgosivir) for treatment of Zika infections.
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 Allowed - 02/16/2021 90072885 24-Jul-20 0081716-000069 16-Aug-23 Statement of Use/3rd Extension of Time Due 13 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. 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.
We do not initially plan to target U.S. government agencies as these organizations, such as the Department of Defense, are expected to be extremely price sensitive until operational considerations justify the use of superior products (the DOD used inexpensive doxycycline for malaria prevention in the low malaria risk setting of Afghanistan, but chose superior weekly mefloquine, despite safety concerns, for the Ebola mission to west Africa in 2014, where malaria rates were extremely high).
We do not initially plan to target U.S. government agencies as these organizations are either contracting their ex-U.S footprints or, as in the case of the Department of Defense, are expected to be extremely price sensitive until operational considerations justify the use of superior products – for example, the DOD used inexpensive doxycycline for malaria prevention in the low malaria risk setting of Afghanistan, but chose superior weekly mefloquine, despite safety concerns, for the Ebola mission to west Africa in 2014, where malaria rates were extremely high.
On February 19, 2021, we entered into an agreement with FSURF, subsequently amended on February 15, 2023, that collectively granted an option, effective through August 19, 2023, to us to license methods for purifying castanospermine and its use for the treatment of COVID-19.
On February 19, 2021, we entered into an agreement with FSURF, subsequently amended on February 15, 2023, and effective on March 24, 2025, that collectively granted an option, effective through March 23, 2026, to us to license methods for purifying castanospermine and its use for the treatment of COVID-19.
There are at least 38,000 cases of potentially treatable acute symptomatic babesiosis (red blood cell infections caused by deer tick bites) in the United States each year. 1 Approximately 650 of these cases are hospitalizations. 2 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. 3 This is much longer than equivalent serious parasitic diseases such as malaria where the goal is a three-day regimen.
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.
Parenteral Tafenoquine for Fungal Infections We plan to support a series of studies in animal models to determine whether single dose parenteral administration of Tafenoquine exhibits efficacy against Candida spp including C. auris . These studies will be conducted under a sponsored research agreement with Monash University in Melbourne, Australia.
Parenteral Tafenoquine for Fungal Infections We plan to support a series of studies in animal models to determine whether single dose parenteral administration of Tafenoquine exhibits efficacy against Candida spp including C. auris . These studies are being conducted under a sponsored research agreement with Monash University in Melbourne, Australia, and should be completed by Q2 2025.
Estimated/ Anticipated Expiration Date 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 ^ 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.
Estimated/ 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.
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.
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.
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.
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 concluded as a result that development of Repositioned Molecules for Dengue, solely and without simultaneous development for other therapeutic use, despite substantial morbidity and mortality in tropical countries, was an effort best suited for philanthropic entities.
Unfortunately, we were unable at that time to raise matching private sector funding. We concluded as a result that development of Repositioned Molecules for Dengue, solely and without simultaneous development for other therapeutic use, despite substantial morbidity and mortality in tropical countries, was an effort best suited for philanthropic entities.
Army Medical Materiel Development Activity (the “U.S. Army”), which was subsequently amended (the “U.S. Army Agreement”), in which we obtained a license to develop and commercialize the licensed technology with respect to all therapeutic applications and uses excluding radical cure of symptomatic vivax malaria.
Army Agreement”), in which we obtained a license to develop and commercialize the licensed technology with respect to all therapeutic applications and uses excluding radical cure of symptomatic vivax malaria.
According to the CDC, there are 50,000 cases of candidiasis (a type of fungal infection) each year in the United States and up to 1,900 clinical cases of C . auris , for which there are few available treatments, have been reported to date. 7 Arakoda has the potential to be a market leading therapy for treatment/prevention of C. auris , and to be added to the standard of care regimens for other Candida infections. ● Prevention of fungal pneumonias .
According to the CDC, there are 50,000 reported cases of candidiasis (a type of fungal infection) each year in the United States and up to 1,900 clinical cases of C . auris , for which there are few available treatments. 14 Since it has broad-spectrum activity against drug-resistant Candida spp in culture, Tafenoquine, has the potential to be a market leading therapy for treatment/prevention of C. auris , and to be added to the standard of care regimens for other Candida infections. 15 ● Prevention of fungal pneumonias .
Celgosivir, a potential clinical candidate of 60P’s, has activity in a number of animal models of important viral diseases such as Dengue and RSV, both of which are associated with at least 4.1 million cases globally according to the European CDC (Dengue) 10 and up to 240,000 hospitalizations (RSV) in children less than five years of age and adults greater than 65 years of age in the United States each year according to the CDC. 11 As outlined in the “ Strategy ” section below, we expect to evaluate Celgosivir in additional non-clinical disease models before making a decision regarding clinical development. 7 https://www.cdc.gov/fungal/diseases/candidiasis/invasive/statistics.html.; https://www.cdc.gov/fungal/candida-auris/tracking-c-auris.html. 8 See statistics for solid organ transplants at the Organ Transplant and Procurement Network at: National data - OPTN (hrsa.gov); See statistics for hematopoietic stem cell transplant in Dsouza et al Biology of Blood and Bone Marrow Transplantation 202;26: e177-e182; See statistics for acute lymphoblastic leukemia at: Key Statistics for Acute Lymphocytic Leukemia (ALL) (cancer.org); See statistics for large cell large B-cell lymphoma at; Diffuse Large B-Cell Lymphoma - Lymphoma Research Foundation; Treatment guidelines recommending antifungal prophylaxis for these diseases can be reviewed in (i) Fishman et al Clinical Transplantation. 2019;33:e13587, (ii) Hematopoietic Cell Transplantation (cancernetwork.com), (iii) Cooper et al Journal of the National Comprehensive Cancer Network 2016;14:882-913 and (iv) Los Arcos et al Infection (2021) 49:215–231. 9 Aguilar-Guisado et al Clin Transplant 2011;25:E629–38; Mace et al MMWR 202;70:1–35 10 https://www.ecdc.europa.eu/en/dengue- monthly#:~:text=This%20is%20an%20increase%20of%2032%20653%20cases%20and%2032,853%20deaths%20have% 20been%20reported. 11 https://www.cdc.gov/rsv/research/index.html#:~:text=Each%20year%20in%20the%20United,younger%20than%205% 20years%20old. &text=58%2C000-80%2C000%20hospitalizations%20among%20children%20younger%20than%205%20years% 20old.&text=60%2C000-120%2C000%20hospitalizations%20among%20adults%2065%20years%20and%20older. 4 More information about our products is provided in the next section, and the status of various development efforts for the above-mentioned diseases is outlined in Figure A, below.
CDC, RSV is responsible for up to 240,000 hospitalizations in children less than five years of age and adults greater than 65 years of age in the United States each year. 20 As outlined in the “ Strategy ” section below, we expect to evaluate Celgosivir in additional non-clinical disease models before making a decision regarding clinical development. 13 Marx et. al., MMWR 2021;70:612-616. 14 https://www.cdc.gov/fungal/diseases/candidiasis/invasive/statistics.html.; https://www.cdc.gov/fungal/candida-auris/tracking-c-auris.html. 15 Dow and Smith New Microb New Infect 2022;45:100964. 16 See statistics for solid organ transplants at the Organ Transplant and Procurement Network at: National data - OPTN (hrsa.gov); See statistics for hematopoietic stem cell transplant in Dsouza et al Biology of Blood and Bone Marrow Transplantation 202;26: e177-e182; See statistics for acute lymphoblastic leukemia at: Key Statistics for Acute Lymphocytic Leukemia (ALL) (cancer.org); See statistics for large cell large B-cell lymphoma at; Diffuse Large B-Cell Lymphoma - Lymphoma Research Foundation; Treatment guidelines recommending antifungal prophylaxis for these diseases can be reviewed in (i) Fishman et al Clinical Transplantation. 2019;33:e13587, (ii) Hematopoietic Cell Transplantation (cancernetwork.com), (iii) Cooper et al Journal of the National Comprehensive Cancer Network 2016;14:882-913 and (iv) Los Arcos et al Infection (2021) 49:215–231. 17 Aguilar-Guisado et al Clin Transplant 2011;25:E629–38; Mace et al MMWR 202;70:1–35. 18 Queener et al JID 1997;165:764-768; Dow and Smith New Microb New Infect 2022;45:100964 19 https://www.ecdc.europa.eu/en/dengue-monthly#:~:text=This%20is%20an%20increase%20of%2032%20653%20cases% 20and%2032,853%20deaths%20have%20been%20reported. 20 https://www.cdc.gov/rsv/php/surveillance/index.html#cdc_survey_profile_surveys_used-rsv-burden-estimates. 7 More information about our products is provided in the next section, and the status of various development efforts for the above-mentioned diseases is outlined in Figure A, below.
There are up to ~ 91-92,000 new medical conditions each year in the United States including acute lymphoblastic leukemia (up to 6.540 cases) and large B-cell lymphoma (up to 18,000 cases) patients receiving CAR-T therapy, solid organ transplant patients (up to 42,887 cases), allogeneic (~ 9,000 cases) and autologous (~ 15,000 cases) hematopoietic stem cell transplant patients for whom the use of antifungal prophylaxis is recommended. 8 Despite the availability and use of antifungal prophylaxis, the risk of some patient groups contracting fungal pneumonia exceeds the risk of contracting malaria during travel to West Africa. 9 Arakoda has the potential to be added to existing standard of care regimens for the prevention of fungal pneumonias.
There are up to ~ 91-92,000 new patient cases each year in the United States for which antifungal prophylaxis is recommended, including acute lymphoblastic leukemia (up to 6,540 cases) and large B-cell lymphoma (up to 18,000 cases) patients receiving CAR-T therapy, solid organ transplant patients (up to 42,887 cases), allogeneic (~ 9,000 cases) and autologous (~ 15,000 cases) hematopoietic stem cell transplant patients. 16 Despite the availability and use of antifungal prophylaxis, the risk of some patient groups contracting fungal pneumonia exceeds the risk of contracting malaria during travel to West Africa. 17 Since it has broad spectrum antifungal effects in cell culture, and activity against Pneumocystis in animal models, Tafenoquine has the potential to be added to existing standard of care regimens for the prevention of fungal pneumonias. 18 Viral Diseases Celgosivir, a potential clinical candidate of 60P’s, has activity in a number of animal models of important viral diseases such as Dengue and RSV.
Pursuant to the OTAP Agreement, we will not offer, sell or otherwise provide the EUA or licensed version of the prototype (Tafenoquine) that is FDA approved for COVID-19 or any like product to any entity at a price lower than that offered to the DoD, which applies only to products sold in the U.S., European Union and Canada related to COVID-19. 14 On February 15, 2021, we entered into the Inter-Institutional Agreement with FSURF (the “FSURF Agreement”) in which FUSRF granted us the right to manage the licensing of intellectual property created at FSURF.
Pursuant to the OTAP Agreement, we will not offer, sell or otherwise provide the EUA or licensed version of the prototype (Tafenoquine) that is FDA approved for COVID-19 or any like product to any entity at a price lower than that offered to the DoD, which applies only to products sold in the U.S., European Union and Canada related to COVID-19.
Moving forward, our general strategy to achieve profitability and grow shareholder value has three facets: (i) increase sales of Arakoda; (ii) conduct clinical trials to expand the number of patients who can use Tafenoquine for new indications in the future; and (iii) reposition small molecule therapeutics with good clinical safety profiles for new indications.” 7 Expansion of U.S.
Moving forward, our general strategy to achieve profitability and grow shareholder value has three facets: (i) increase sales of Arakoda; (ii) conduct clinical trials to expand the number of patients who can use Tafenoquine for new indications in the future; and (iii) reposition small molecule therapeutics with good clinical safety profiles for new indications. 30 Sorbera et al, Drugs of the Future 2005; 30:545-552. 31 Low et. al., Lancet ID 2014; 14:706-715. 32 Watanabe et al, Antiviral Research 2016; 10:e19. 10 Expansion of U.S.
Our human capital resources objectives include, as applicable, identifying, recruiting, retaining, incentivizing and integrating our existing and new employees, advisors and consultants.
We also utilize the services of two part-time contractors. Our human capital resources objectives include, as applicable, identifying, recruiting, retaining, incentivizing and integrating our existing and new employees, advisors and consultants.
Malaria Journal 2014, 13:49; Novitt-Moreno et al Travel Med Infect Dis 2022 Jan-Feb;45:102211. 5 The only limitation of Arakoda is the requirement for a G6PD test prior to administration. 15 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. 16 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. 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.
In two of three recent clinical case studies, Tafenoquine administered after failure of conventional antibiotics in immunosuppressed babesiosis patients resulted in cures. 19 Consequently, we believe that (i) if combined with standard of care products, Tafenoquine has the potential to reduce the duration of treatment with antibiotic therapy in immunosuppressed patients and the time to parasite clearance in non-immunosuppressed patients and (ii) that once appropriate clinical studies have been conducted, it is likely that Tafenoquine would be quickly embraced for post-exposure prophylaxis of babesiosis in patients with tick bites and suspected of being co-infected with Lyme disease.
Consequently, we believe that (i) if combined with standard of care products, Tafenoquine has the potential to accelerate parasite clearance and reduce the duration of illness and treatment with antibiotic therapy in immunosuppressed patients hospitalized with severe illness, (ii) once appropriate clinical studies have been conducted, it is likely that Tafenoquine would be quickly embraced for post-exposure prophylaxis of babesiosis in patients with tick bites, and (iii) Tafenoquine could become the leading treatment for Chronic Babesiosis.
This includes aggregate reductions of Medicare payments to providers of up to 2% per fiscal year, which went into effect in April 2013 and will remain in effect through 2024 unless additional Congressional action is taken.
This includes aggregate reductions of Medicare payments to providers of up to 2% per fiscal year, which went into effect in April 2013 and, due to subsequent legislative amendments to the statute, will remain in effect through 2030 unless additional Congressional action is taken. The reductions have been suspended temporarily through December 2021 in response to the COVID-19 pandemic.
In addition, the Senate considered proposed healthcare reform legislation known as the Graham-Cassidy bill. None of these measures were passed by the U.S. Senate.
In addition, the Senate considered proposed healthcare reform legislation known as the Graham-Cassidy bill. None of these measures were passed by the U.S. Senate. The ACA has also been challenged numerous times in various court cases, including challenges before the U.S. Supreme Court.
We will continue to evaluate the effect that the ACA and its possible repeal and replacement could have on our business.
Congress will likely consider other legislation to replace elements of the ACA, during the next Congressional session. We will continue to evaluate the effect that the ACA and its possible repeal and replacement could have on our business.
Arakoda Regimen of Tafenoquine for Babesiosis In animal models, Tafenoquine monotherapy has been shown to suppress acute babesiosis infections to the point where the immune system can control them following single or multiple doses similar to those effective against malaria parasites, and combination of Tafenoquine with atovaquone leads to complete radical cure and to the conference of sterile immunity. 23 In three case studies in individuals with immunosuppression and/or refractory parasites, Tafenoquine alone or combination with various standard of care antimalarials and antibiotics successfully cleared parasites leading to three consecutive negative PCR tests, and prevention of further relapses in two of three individuals. 24 Collectively these data suggest Tafenoquine might have utility as monotherapy in patients with uncomplicated babesiosis and improve clinical outcomes in hospitalized/immunosuppressed patients already administered standard of care antibiotic regimens. 23 Liu et al.
Development of the Arakoda Regimen of Tafenoquine for Babesiosis In animal models, Tafenoquine monotherapy has been shown to suppress acute babesiosis infections to the point where the immune system can control them following single or multiple doses similar to those effective against malaria parasites, and longer regimens alone or in combination with atovaquone leads to complete radical cure and to the conference of sterile immunity. 33 In three case studies in individuals with immunosuppression and/or refractory parasites, Tafenoquine alone or in combination with various standard of care antimalarials and antibiotics successfully cleared parasites, leading to three consecutive negative PCR tests, and prevention of further relapses in two of three individuals. 34 Our market research has revealed that recent sales growth for Arakoda is primarily attributable to organic growth in prescribing by Lyme community prescribers for Chronic Babesiosis.
Medicinal products designated as orphan drugs pursuant to Regulation 141/2000 shall be eligible for incentives made available by the European Community and by the member states to support research into, and the development and availability of, orphan drugs.
Medicinal products designated as orphan drugs pursuant to Regulation 141/2000 shall be eligible for incentives made available by the European Community and by the member states to support research into, and the development and availability of, orphan drugs. 33 Regulatory Framework in Australia The Therapeutic Goods Administration, through the Therapeutic Goods Act 1989 and the Therapeutic Goods Regulations is responsible for the efficacy, quality, safety and timely availability of drugs and medical devices in Australia.
Celgosivir Celgosivir is a host targeted glucosidase inhibitor that was developed separately by other sponsors for HIV then for hepatitis C. 20 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 National University of Singapore initiated development of Celgosivir independently for Dengue fever.
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.
In animal models, this problem can be addressed for Celgosivir, 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). 22 This observation led to the filing and approval of a patent related to Dengue, which we licensed from the National University of Singapore. 15 See prescribing information at www.arakoda.com. 16 See prescribing information at www.arakoda.com. 17 Dow and Smith, New Microbe and New Infect 2022; 45: 100964. 18 Queener et al Journal of Infectious Diseases 1992;165:764-8). 19 Liu et al.
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.
Although none of these measures have been enacted by Congress to date, Congress may consider other legislation to repeal and replace elements of the ACA. Congress will likely consider other legislation to replace elements of the ACA, during the next Congressional session.
Further, each chamber of Congress has put forth multiple bills designed to repeal or repeal and replace portions of the ACA. Although none of these measures have been enacted by Congress to date, Congress may consider other legislation to repeal and replace elements of the ACA.
Due to the success of the qualified IPO, at the end of the quarter and each quarter thereafter the royalty will be calculated, and payment will be made within fifteen days.
Due to the success of the qualified IPO, at the end of the quarter and each quarter thereafter the royalty will be calculated, and payment will be made within fifteen days. 17 Sales and Marketing In 2025, we plan to “relaunch” Arakoda for malaria prevention in the United States as described in the “Strategy” section.
The 2014 NUS-SHS Agreement continues in force until the expiration of the last to expire of any patents under the patent rights unless terminated earlier in accordance with the 2014 NUS-SHS Agreement. We are obligated to pay at the rate of 1.5% of gross sales. On July 15, 2015, we entered into the Exclusive License Agreement with the U.S.
The 2014 NUS-SHS Agreement continues in force until the expiration of the last to expire of any patents under the patent rights unless terminated earlier in accordance with the 2014 NUS-SHS Agreement.
We estimate the cost of conducting the study proposed by the FDA, if conducted in the manner suggested by the FDA, would be $2 million, and, due to the time periods required to secure protocol approvals from the FDA and Ethics Committees, could not be initiated any earlier than the third quarter of 2025.
We estimate the cost of conducting the study proposed by the FDA, if conducted in the manner suggested by the FDA, would be $2 million, and, due to the time periods required to secure protocol approvals from the FDA and Ethics Committees, could not be initiated any earlier than the Second quarter of 2026. 36 See: https://clinicaltrials.gov/study/NCT06478641. 37 Velez et al 2021 - Lancet Child Adolesc Health 2022; 6: 86–95. 12 Intellectual Property We are co-owners, with the U.S.
Dow, Ph.D. is a listed inventor. 12 All patents not designated with a “+” list Geoffrey S. Dow, Ph.D. as an inventor. All patents not designated with a “+” or a “#” list 60 Degrees Pharmaceuticals, Inc. as an applicant. All estimated patent expiration dates and anticipated patent expiration assume payment of any maintenance/annuity fees during the patent term.
All patents not designated with a “+” list Geoffrey S. Dow, Ph.D. as an inventor. All patents not designated with a “+” or a “#” list 60 Degrees Pharmaceuticals, Inc. as an applicant.
A treatment course of Tafenoquine mirroring the human prophylactic dose in dogs might cost ● Prevention of Tick-Borne Diseases . Post-exposure prophylaxis or early treatment with, respectively, a single dose or several week regimen of doxycycline following a tick-bite is a recognized indication to prevent the complications of Lyme disease.
Post-exposure prophylaxis or early treatment with, respectively, a single dose or several week regimen of doxycycline following a tick-bite is a recognized indication to prevent the complications of Lyme disease. There may be more than 400,000 such tick bites in the United States requiring medical treatment each year.
We will monitor this issue to determine the effects of this legislation on our business. 36 Human Capital Resources As of April 1, 2024, we had a total of three employees, all of whom are full-time. We also utilize the services of two part-time contractors.
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.
(as Arakoda) and Australia (as Kodatef) in the third quarter of 2019. 12 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. 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).

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Item 1C. Cybersecurity

Cybersecurity — threats and controls disclosure

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Biggest changeDespite our efforts to improve our cybersecurity measures, there can be no assurance that our initiatives will fully mitigate the risks posed by cyber threats. The landscape of cybersecurity risks is constantly evolving, and we will continue to assess and update our cybersecurity measures in response to emerging threats.
Biggest changeThe 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 January 22, 2024 titled “ Cybersecurity risks could adversely affect our business and disrupt our operations .”
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 .”
Such events could potentially lead to unauthorized access to, or disclosure of, sensitive information, disrupt our business operations, result in regulatory fines or litigation costs and negatively impact our reputation among customers and partners. 37 We are in the process of evaluating our cybersecurity needs and developing appropriate measures to enhance our cybersecurity posture.
Such events could potentially lead to unauthorized access to, or disclosure of, sensitive information, disrupt our business operations, result in regulatory fines or litigation costs and negatively impact our reputation among customers and partners.
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.
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.
Added
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.
Added
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. 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.
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.
Removed
We currently lease two offices at the above address and, as a result of the renewal of our lease for an additional one-year in January 2023, recognized a gross Right of Use Asset of $63,570 as of December 31, 2023 with offsetting accumulated depreciation of $50,053 ($99,615 as of December 31, 2022 with offsetting accumulated depreciation of $86,967).
Removed
In December 2023, we executed a new lease amendment to relocate to a new office in the same building beginning April 1, 2024, and expiring on March 31, 2025.

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. 38 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. Item 4. Mine Safety Disclosures. Not applicable. 40 PART II

Item 5. Market for Registrant's Common Equity

Market for Common Equity — stock, dividends, buybacks

8 edited+43 added−7 removed6 unchanged
Biggest changeEQUITY PLAN INFORMATION Plan Category: Number of securities to be issued upon exercise or issuance of outstanding options, units, warrants and rights: Weighted average exercise price of outstanding options, warrants and rights (1) : Number of securities remaining available for future issuance: 2022 Equity Incentive Plan: Equity compensation plans approved by security holders 293,736 $ 5.30 305 Equity compensation plans not approved by security holders 770,188 1.17 - Total 1,063,924 $ 1.36 305 (1) The calculation for the weighted average exercise price of outstanding options, warrants and rights excludes 256,000 restricted stock units approved by security holders under the 2022 Plan as the awards do not have an exercise price.
Biggest changeEQUITY PLAN INFORMATION Plan Category: Number of securities to be issued upon exercise or issuance of outstanding options, units, warrants and rights (1) : Weighted average exercise price of outstanding options, warrants and rights (1) : Number of securities remaining available for future issuance (1) : 2022 Equity Incentive Plan: Equity compensation plans approved by security holders 4,437 $ 116.07 154,392 Equity compensation plans not approved by security holders — — — Total 4,437 $ 116.07 154,392 (1) Balances presented as of December 31, 2024 45 Purchases of Equity Securities by the Issuer and Affiliated Purchasers None.
The issuance of shares of Series A Preferred Stock listed above was deemed exempt from registration under Section 4(a)(2) of the Securities Act or Regulation D promulgated thereunder in that the issuance of securities did not involve a public offering. 2022 Equity Incentive Plan On November 22, 2022, the Board and majority stockholder adopted the 60 Degrees Pharmaceuticals, Inc. 2022 Equity Incentive Plan (the “2022 Plan”).
The issuance of shares of Series A Preferred Stock listed above was deemed exempt from registration under Section 4(a)(2) of the Securities Act or Regulation D promulgated thereunder in that the issuance of securities did not involve a public offering. 44 2022 Equity Incentive Plan On November 22, 2022, the Board and majority stockholder adopted the 60 Degrees Pharmaceuticals, Inc. 2022 Equity Incentive Plan (the “2022 Plan”).
Therefore, we do not expect to pay cash dividends in the foreseeable future. Any future determination to pay dividends will be at the discretion of our Board of Directors (“Board”) and will depend on our financial condition, results of operations, capital requirements, and other factors that our Board deems relevant.
Therefore, we do not expect to pay cash dividends in the foreseeable future. Any future determination to pay dividends will be at the discretion of our Board and will depend on our financial condition, results of operations, capital requirements, and other factors that our Board deems relevant.
Item 5. Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities. Market Information Our common stock is currently listed on The Nasdaq Capital Market under the symbol “SXPT,” and warrants under the symbol “SXPTW.” Trading in our common stock has historically lacked consistent volume, and the market price has been volatile.
Item 5. Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities. Market Information Our common stock is currently listed on The Nasdaq Capital Market under the symbol “SXTP,” and warrants under the symbol “SXTPW.” Trading in our common stock has historically lacked consistent volume, and the market price has been volatile.
Initially, the Board reserved 238,601 shares of common stock issuable upon the grant of awards under the 2022 Plan.
Initially, the Board reserved 3,977 shares of common stock issuable upon the grant of awards under the 2022 Plan.
On March 28, 2024, the closing price for our common stock and warrants as reported on The Nasdaq Capital Market was $0.2610 per share and $0.0760, respectively. Holders of Common Stock On April 1, 2024, there were 14 holders of record of our common stock.
On March 26, 2025 the closing price for our common stock and warrants as reported on The Nasdaq Capital Market was $1.88 per share and $0.024, respectively. Holders of Common Stock On March 27, 2025, there were 21 holders of record of our common stock.
The issuances of shares of common stock listed above were deemed exempt from registration under Section 4(a)(2) of the Securities Act or Regulation D promulgated thereunder in that the issuance of securities did not involve a public offering. 40 Preferred Stock ● On July 14, 2023, we converted the accumulated interest from the debt owed to Knight into 80,965 shares of our Series A Preferred Stock, of which were issued to Knight.
The issuances of shares of common stock listed above were deemed exempt from registration under Section 4(a)(2) of the Securities Act or Regulation D promulgated thereunder in that the issuance of securities did not involve a public offering. 41 Warrants On September 4, 2024, we issued 579,711 pre-funded warrants, 579,711 Series A Warrants and 579,711 Series B Warrants to investors in a private offering.
Dow Revocable Trust as a result of the conversion of the Convertible Promissory Note we issued to the Geoffrey S.
On May 19, 2022, we issued the Convertible Promissory Note to Geoffrey Dow, as assigned to the Geoffrey S. Dow Revocable Trust dated August 27, 2018 (the “Dow Note”), in the amount of $44,444.44 and a per annum interest rate of 6%.
Removed
Unregistered Sales of Equity Securities Common Stock ● On January 2, 2023, we issued a total of 100,000 shares of our common stock to our legal counsel for payment of certain legal fees. ● On January 26, 2023, we issued 405,000 shares of our common stock to Florida State University Research Foundation Inc. in exchange for its research and development services. ● On January 26, 2023, we issued 65,000 shares of our common stock to Latham BioPharm Group, LLC in exchange for its research and development services. ● On January 26, 2023, we issued 120,000 shares of our common stock to Trevally, LLC in exchange for provision of research chemicals. ● On January 26, 2023, we issued 8,500 shares of our common stock to ENA Healthcare Communications, LLC in exchange for marketing services. ● On January 26, 2023, we issued 54,000 shares of our common stock to 4C Pharma Solutions, LLC in exchange for the cancellation of debt and credit for pharmacovigilance services to be provided. ● On January 26, 2023, we issued 65,000 shares of our common stock to Hybrid Financial in exchange for its investor relations services. ● On January 26, 2023, we issued 20,000 shares of our common stock to Sheila Burke in exchange for public relations services provided by Method Health Communications LLC. ● On January 26, 2023, we issued 525,000 shares of our common stock to University of Kentucky School of Pharmacy in exchange for its research and development services. 39 ● On January 26, 2023, we issued 37,500 shares of our common stock to Ludlow Business Services, Inc. in exchange for its investor relations services. ● On January 26, 2023, we issued 30,000 shares of our common stock to Elliot Berman in exchange for accounting services provided by Berman Accounting & Advisory P.A. ● On March 19, 2023, we issued 13,000 shares of our common stock to Delve Innovation Pty Ltd in exchange for its research and development services. ● On July 11, 2023, we issued 10,482 of our common stock to Geoffrey S.
Added
Reverse Stock Split On November 6, 2024, our Board approved a reverse stock split of our Common Stock at a split ratio ranging between 1:3 and 1:5, as determined by the Board in its sole discretion. On November 6, 2024, a majority of the stockholders of the Company approved the proposed reverse stock split.
Removed
Dow Revocable Trust on May 19, 2022. ● On July 11, 2023, we issued 52,411 shares of our common stock to Walleye Opportunities Master Fund Ltd. as a result of the conversion of the Convertible Promissory Note we issued to Walleye Opportunities Master Fund Ltd. on May 24, 2022. ● On July 11, 2023, we issued 62,893 shares of our common stock to Bigger Capital Fund, LP as a result of the conversion of the Convertible Promissory Note we issued to Bigger Capital Fund, LP on May 24, 2022. ● On July 11, 2023, we issued 52,411 shares of our common stock to Cavalry Investment Fund, LP. as a result of the conversion of the Convertible Promissory Note we issued to Cavalry Investment Fund, LP. on May 24, 2022. ● On July 11, 2023, we issued 20,964 shares of our common stock to Cyberbahn Federal Solutions, LLC. as a result of the conversion of the Convertible Promissory Note we issued to Cyberbahn Federal Solutions, LLC on May 8, 2023. ● On July 11, 2023, we issued 20,964 shares of our common stock to Ariana Bakery Inc as a result of the conversion of the Convertible Promissory Note we issued to Ariana Bakery Inc on May 8, 2023. ● On July 11, 2023, we issued 62,893 shares of our common stock to Sabby Volatility Warrant Master Fund, Ltd. as a result of the conversion of the Convertible Promissory Note we issued to Sabby Volatility Warrant Master Fund, Ltd. on May 8, 2023. ● On July 11, 2023, we issued 10,482 shares of our common stock to Steel Anderson as a result of the conversion of the Convertible Promissory Note we issued to Steel Anderson on May 8, 2023. ● On July 11, 2023, we issued 20,964 shares of our common stock to Bixi Gao & Ling Ling Wang as a result of the conversion of the Convertible Promissory Note we issued to Bixi Gao & Ling Ling Wang on May 8, 2023. ● On July 11, 2023, we issued a total of 40,000 restricted shares of common stock to the following directors and in the amounts listed: (i) Stephen Toovey (10,000 restricted shares of common stock), (ii) Charles Allen (10,000 restricted shares of common stock), (iii) Paul Field (10,000 restricted shares of common stock) and (iv) Cheryl Xu (10,000 restricted shares of common stock). ● On July 14, 2023, we issued a total of 29,245 restricted shares of our common stock to BioIntelect Pty Ltd as deferred equity compensation valued in the amount of $155,000. ● On July 14, 2023, we converted the entirety of debt owed to a noteholder to 214,934 shares of our common stock at the conversion price equal to the initial public offering price, of which were issued to Xu Yu. ● On July 14, 2023, we issued 1,108,337 restricted shares of common stock to Knight Therapeutics (Barbados) Inc.) (“Knight”) upon conversion of debt owed to Knight. ● On July 28, 2023, we issued 45,560 restricted shares of our common stock to Knight upon conversion of 2,162 shares of Series A Preferred Stock, at the conversion rate price detailed in Note 6 to the accompanying consolidated condensed financial statements.
Added
On February 10, 2025, the Board approved a 1-for-5 reverse split ratio. On February 24, 2025, the Company effectuated a 1-for-5 reverse stock split of our common stock (the “1:5 Reverse Stock Split”). Beginning February 24, 2025, our common stock traded on The Nasdaq Capital Market on a split adjusted basis.
Removed
Use of Proceeds from our Initial Public Offering The registration statement for our initial public offering was declared effective by the SEC on July 11, 2023.
Added
In July 2024, our Board approved a reverse stock split of our Common Stock at a split ratio ranging between 1:5 and 1:12, as determined by the Board in its sole discretion. On July 16, 2024, a majority of the stockholders of the Company approved the proposed reverse stock split.
Removed
The initial public offering consisted of 1,415,095 units, with each unit consisting of (i) one share of our common stock, (ii) one tradeable warrant having the right to purchase one share of our common stock at an exercise price of $6.095 per share and (iii) one non-tradeable warrant having the right to purchase one share of our common stock at an exercise price of $6.36 per share, at a public offering price of $5.30 per unit.
Added
On July 19, 2024, our Board approved a 1-for-12 reverse split ratio. On August 12, 2024, the Company effectuated a 1-for-12 reverse stock split of our common stock (the “1:12 Reverse Stock Split” and together, with the 1:5 Reverse Stock Split, the “Reverse Stock Splits”).
Removed
On July 14, 2023, the initial public offering closed, and we received $6,454,325 in net proceeds from the initial public offering after deducting the underwriting discount and commission and other estimated initial public offering expenses payable by us.
Added
Beginning August 12, 2024, our common stock traded on The Nasdaq Capital Market on a split adjusted basis. All common share and applicable per share amounts in this Annual Report on Form 10-K have been retroactively restated to reflect the effect of the Reverse Stock Splits.
Removed
There has been no material change in the planned use of proceeds from such use as described in our initial public offering registration statement.
Added
Unregistered Sales of Equity Securities Common Stock ● On July 22, 2024 and July 26, 2024, we issued 8,000 and 6,667 shares of common stock to Knight, respectively, upon conversion of 1,291 and 1,032 shares of Series A Preferred Stock, respectively, at the conversion price detailed in Note 6 to the accompanying consolidated financial statements. ● From October 2024 to January 2025, we issued an aggregate of 579,711 shares of common stock upon the exercise of pre-funded warrants issued to investors in the September 2024 private placement.
Removed
As of December 31, 2023, we have utilized approximately $4,000,000 of the net proceeds as follows: ● $1,729,000 for working capital and general corporate purposes; ● $1,783,000 for debt repayment; and ● $488,000 research and development (clinical trials and related activities). 41 Purchases of Equity Securities by the Issuer and Affiliated Purchasers None. Item 6. [Reserved] Not applicable.
Added
The Pre-Funded Warrants are exercisable immediately upon issuance and expire when exercised in full at an exercise price of $0.005 per share.
Added
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 (the “Stockholder Approval”), which was received on November 6, 2024.
Added
The Series A Warrants will expire five years from Stockholder Approval and the Series B Warrants will expire eighteen (18) months from Stockholder Approval. H.C. Wainwright & Co., LLC acted as the exclusive placement agent in connection with the Private Placement.
Added
In connection with the Private Placement, we issued to Wainwright the Placement Agent Warrants to purchase 43,479 shares of 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 the Stockholder Approval for five years from Stockholder Approval.
Added
In January 2025, we issued 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.
Added
We 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 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.
Added
On February 5, 2025, we issued 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.
Added
We 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 have an exercise price equal to $4.469 per share and are exercisable upon issuance, or February 6, 2025, for twenty-four months from the date of issuance, or February 8, 2027.
Added
The warrants described above were deemed exempt from registration in reliance on Section 4(a)(2) of the Securities Act or Regulation D promulgated thereunder in that the issuance of securities were made to an accredited investor and did not involve a public offering.
Added
The recipients of such securities represented its intention to acquire the securities for investment purposes only and not with a view to or for sale in connection with any distribution thereof.
Added
Option Grants On July 16, 2024, the effective date of shareholder approval to increase the number of shares authorized under the 2022 Plan, we granted a total of 504 fully vested, non-qualified options to purchase shares of common stock at a per share exercise price of $318.00 to the following directors and in the amounts listed: (i) Stephen Toovey (126 common stock options), (ii) Charles Allen (126 common stock options), (iii) Paul Field (126 common stock options) and (iv) Cheryl Xu (126 common stock options). 42 On July 16, 2024, the effective date of shareholder approval to increase the number of shares authorized under the 2022 Plan, we granted a total of 12,334 options to purchase shares of common stock at a per share exercise price of $60.00 to Geoff Dow, our Chief Executive Officer, (5,000 common stock options), Tyrone Miller, our Chief Financial Officer (4,000 common stock options), and Bryan Smith, an external consultant, (3,334 common stock options).
Added
These options vest in five equal tranches on the last date of each fiscal year, with the first vesting date being December 31, 2024.
Added
On September 26, 2024, we granted 4,167 options to purchase shares of common stock at a per share exercise price of $6.85 to Kristen Landon, our Chief Commercial Officer, which vest in five equal tranches on the last date of each fiscal year, with the first vesting date being December 31, 2024.
Added
On January 2, 2025, we granted a total of 120,000 options to purchase shares of common stock at a per share exercise price of $6.55 to Geoff Dow, our Chief Executive Officer, (105,000 common stock options) and Tyrone Miller, our Chief Financial Officer (15,000 common stock options), which vest in five equal tranches.
Added
The first tranche was fully vested on the date of grant and thereafter, the options vest on the last date of each fiscal year beginning December 31, 2025. Issuance of Notes On May 14, 2020, we issued the Note to the U.S. Small Business Administration with a principal amount of $150,000 and a per annum interest rate of 3.75%.
Added
Immediately prior to the closing of our initial public offering, the balance of the Dow Note converted at a price equal to 80% of the IPO price. On May 19, 2022, we issued the Mountjoy Note in the amount of $294,444.42 and a per annum interest rate of 6%.
Added
Immediately prior to the closing of our initial public offering, the balance of the Mountjoy Note converted at a price equal to 80% of the IPO price. On May 24, 2022, we issued the Bigger Capital Fund Note in the amount of $333,333.30 to Bigger Capital Fund, LP.
Added
On the date of the pricing of our initial public offering, we delivered to Bigger Capital Fund, LP shares of our common stock equal to the number of shares of common stock calculated using a share price of the IPO price.
Added
On May 24, 2022, we issued the Cavalry Investment Fund Note in the amount of $277,777.78 to Cavalry Investment Fund, LP.
Added
On the date of the pricing of our initial public offering, we delivered to Cavalry Investment Fund, LP shares of our common stock equal to the number of shares of common stock calculated using a share price of the IPO price. 43 On May 24, 2022, we issued the Walleye Note in the amount of $277,777.78 to Walleye Opportunities Master Fund Ltd.
Added
On the date of the pricing of our initial public offering, we delivered to Walleye Opportunities Master Fund Ltd shares of our common stock equal to the number of shares of common stock calculated using a share price of the IPO price.
Added
On May 8, 2023, we issued the Cyberbahn Note in the amount of $111,111.10 to Cyberbahn Federal Solutions, LLC with a 10% original issue discount.
Added
On the date of the pricing of our initial public offering, we delivered to Cyberbahn Federal Solutions, LLC shares of our common stock equal to the number of shares of our common stock calculated using a share price of the IPO price.
Added
On May 8, 2023, we issued the Ariana Note in the amount of $111,111.10 to Ariana Bakery Inc with a 10% original issue discount.
Added
On the date of the pricing of our initial public offering, we delivered to Ariana Bakery Inc shares of our common stock equal to the number of shares of our common stock calculated using a share price of the IPO price.
Added
On May 8, 2023, we issued the Sabby Note in the amount of $333,333.30 to Sabby Volatility Warrant Master Fund, Ltd. with a 10% original issue discount.
Added
On the date of the pricing of our initial public offering, we delivered to Sabby Volatility Warrant Master Fund, Ltd. shares of our common stock equal to the number of shares of our common stock calculated using a share price of the IPO price.
Added
On May 8, 2023, we issued the Anderson Note in the amount of $55,555.55 to Steel Anderson with a 10% original issue discount.
Added
On the date of the pricing of our initial public offering, we delivered to Steel Anderson shares of our common stock equal to the number of shares of our common stock calculated using share price of the IPO price.
Added
On May 8, 2023, we issued the Gao & Wang Note in the amount of $111,111.10 to Bixi Gao & Ling Ling Wang with a 10% original issue discount.
Added
On the date of the pricing of our initial public offering, we delivered to Bixi Gao & Ling Ling Wang shares of our common stock equal to the number of shares of our common stock calculated using a share price of the IPO price.
Added
The notes described above were deemed exempt from registration in reliance on Section 4(a)(2) of the Securities Act or Regulation D promulgated thereunder in that the issuance of securities were made to an accredited investor and did not involve a public offering.
Added
The recipients of such securities represented its intention to acquire the securities for investment purposes only and not with a view to or for sale in connection with any distribution thereof.
Added
Preferred Stock ● On July 14, 2023, we converted the accumulated interest from the debt owed to Knight into 80,965 shares of our Series A Preferred Stock, of which were issued to Knight.
Added
On July 16, 2024 and November 6, 2024, our stockholders approved an increase to the number of shares available under the 2022 Plan by 83,334 shares and 100,000 shares, respectively, which increases were previously approved by the Board.
Added
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.
Added
This increase is essential to attract and retain qualified employees, directors and consultants, and to align their interests with those of our stockholders.

Item 7. Management's Discussion & Analysis

Management's Discussion & Analysis (MD&A) — revenue / margin commentary

65 edited+53 added−48 removed18 unchanged
Biggest changeResults of Operations The following table sets forth our results of operations for the periods presented: For the Year Ended December 31, Consolidated Statements of Operations Data: 2023 2022 Product Revenues – net of Discounts and Rebates $ 253,573 $ 192,913 Service Revenues - 30,295 Product and Service Revenues, net 253,573 223,208 Cost of Revenues 474,550 432,370 Gross Loss (220,977 ) (209,162 ) Research Revenues - 288,002 Net (Loss) Revenue (220,977 ) 78,840 Operating Expenses: Research and Development 691,770 525,563 General and Administrative Expenses 4,241,836 1,303,722 Total Operating Expenses 4,933,606 1,829,285 Loss from Operations (5,154,583 ) (1,750,445 ) Interest Expense (2,286,637 ) (3,989,359 ) Derivative Expense (399,725 ) (504,613 ) Change in Fair Value of Derivative Liabilities (37,278 ) (10,312 ) (Loss) Gain on Debt Extinguishment (1,231,480 ) 120,683 Change in Fair Value of Promissory Note 5,379,269 - Other Expenses, net (83,116 ) (43,238 ) Total Interest and Other Income (Expense), net 1,341,033 (4,426,839 ) Loss from Operations before Provision for Income Taxes (3,813,550 ) (6,177,284 ) Provision for Income Taxes 250 500 Net Loss including Noncontrolling Interest (3,813,800 ) (6,177,784 ) Net (Loss) Income – Noncontrolling Interest (48,098 ) 3,936 Net Loss – attributed to 60 Degrees Pharmaceuticals, Inc. $ (3,765,702 ) $ (6,181,720 ) 43 The following table sets forth our results of operations as a percentage of revenue: For the Year Ended December 31, Consolidated Statements of Operations Data: 2023 2022 Product Revenues – net of Discounts and Rebates 100.00 % 86.43 % Service Revenues - 13.57 Product and Service Revenues, net 100.00 100.00 Cost of Revenues 187.15 193.71 Gross Loss (87.15 ) (93.71 ) Research Revenues - 129.03 Net (Loss) Revenue (87.15 ) 35.32 Operating Expenses: Research and Development 272.81 235.46 General and Administrative Expenses 1,672.83 584.08 Total Operating Expenses 1,945.64 819.54 Loss from Operations (2,032.78 ) (784.22 ) Interest Expense (901.77 ) (1,787.28 ) Derivative Expense (157.64 ) (226.07 ) Change in Fair Value of Derivative Liabilities (14.70 ) (4.62 ) (Loss) Gain on Debt Extinguishment (485.65 ) 54.07 Change in Fair Value of Promissory Note 2,121.39 - Other Expenses, net (32.78 ) (19.37 ) Total Interest and Other Income (Expense), net 528.85 (1,983.28 ) Loss from Operations before Provision for Income Taxes (1,503.93 ) (2,767.50 ) Provision for Income Taxes 0.10 0.22 Net Loss including Noncontrolling Interest (1,504.02 ) (2,767.73 ) Net (Loss) Income – Noncontrolling Interest (18.97 ) 1.76 Net Loss – attributed to 60 Degrees Pharmaceuticals, Inc.
Biggest changeResults of Operations The following table sets forth our results of operations for the periods presented: For the Year Ended December 31, Consolidated Statements of Operations Data: 2024 2023 Product Revenues – net of Discounts and Rebates $ 607,574 $ 253,573 Cost of Revenues 384,765 474,550 Gross Profit (Loss) 222,809 (220,977 ) Research Revenues 73,771 - Net Revenue (Loss) 296,580 (220,977 ) Operating Expenses: Research and Development 4,986,526 691,770 General and Administrative Expenses 5,024,985 4,241,836 Total Operating Expenses 10,011,511 4,933,606 Loss from Operations (9,714,931 ) (5,154,583 ) Interest Expense (7,912 ) (2,286,637 ) Derivative Expense - (399,725 ) Change in Fair Value of Derivative Liabilities 1,665,966 (37,278 ) Loss on Debt Extinguishment - (1,231,480 ) Change in Fair Value of Promissory Note - 5,379,269 Other Income (Expense), net 101,464 (83,116 ) Total Interest and Other Income (Expense), net 1,759,518 1,341,033 Loss from Operations before Provision for Income Taxes (7,955,413 ) (3,813,550 ) Provision for Income Taxes (Note 9) 250 250 Net Loss including Noncontrolling Interest (7,955,663 ) (3,813,800 ) Net Loss – Noncontrolling Interest (8,556 ) (48,098 ) Net Loss – attributed to 60 Degrees Pharmaceuticals, Inc. $ (7,947,107 ) $ (3,765,702 ) 48 The following table sets forth our results of operations as a percentage of revenue: For the Year Ended December 31, Consolidated Statements of Operations Data: 2024 2023 Product Revenues – net of Discounts and Rebates 100.00 % 100.00 % Cost of Revenues 63.33 187.15 Gross Profit (Loss) 36.67 (87.15 ) Research Revenues 12.14 - Net Revenue (Loss) 48.81 (87.15 ) Operating Expenses: Research and Development 820.73 272.81 General and Administrative Expenses 827.06 1,672.83 Total Operating Expenses 1,647.78 1,945.64 Loss from Operations (1,598.97 ) (2,032.78 ) Interest Expense (1.30 ) (901.77 ) Derivative Expense - (157.64 ) Change in Fair Value of Derivative Liabilities 274.20 (14.70 ) Loss on Debt Extinguishment - (485.65 ) Change in Fair Value of Promissory Note - 2,121.39 Other Income (Expense), net 16.70 (32.78 ) Total Interest and Other Income (Expense), net 289.60 528.85 Loss from Operations before Provision for Income Taxes (1,309.37 ) (1,503.93 ) Provision for Income Taxes (Note 9) 0.04 0.10 Net Loss including Noncontrolling Interest (1,309.41 ) (1,504.02 ) Net Loss – Noncontrolling Interest (1.41 ) (18.97 ) Net Loss – attributed to 60 Degrees Pharmaceuticals, Inc.
An explanation of these non-GAAP financial measures and a reconciliation to the most directly comparable GAAP financial measures are included in this “Management’s Discussion and Analysis of Financial Condition and Results of Operations.” Investors should not consider non-GAAP financial measures in isolation or as substitutes for financial information presented in compliance with GAAP.
An explanation of these non-GAAP financial measures and a reconciliation to the most directly comparable GAAP financial measures are included in this “Management’s Discussion and Analysis of Financial Condition and Results of Operations.” Investors should not consider non-GAAP financial measures in isolation or as substitutes for financial information presented in compliance with GAAP. 1.
As of December 31, 2023, our derivative financial instruments consist of contingent payment arrangements. We analyze all financial instruments with features of both liabilities and equity under the Financial Accounting Standards Board (“FASB”) Accounting Standards Codification (“ASC”) Topic No. 480, (“ASC 480”), Distinguishing Liabilities from Equity and FASB ASC Topic No. 815, Derivatives and Hedging (“ASC 815”).
As of December 31, 2024, our derivative financial instruments consist of contingent payment arrangements. We analyze all financial instruments with features of both liabilities and equity under the Financial Accounting Standards Board (“FASB”) Accounting Standards Codification (“ASC”) Topic No. 480, Distinguishing Liabilities from Equity (“ASC 480”), and FASB ASC Topic No. 815, Derivatives and Hedging (“ASC 815”).
Off-Balance Sheet Arrangements During 2023 and 2022, we did not have any relationships with unconsolidated organizations or financial partnerships, such as structured finance or special purpose entities that would have been established for the purpose of facilitating off-balance sheet arrangements or other contractually narrow or limited purposes. JOBS Act Accounting Election In April 2012, the JOBS Act was enacted.
Off-Balance Sheet Arrangements During 2024 and 2023, we did not have any relationships with unconsolidated organizations or financial partnerships, such as structured finance or special purpose entities that would have been established for the purpose of facilitating off-balance sheet arrangements or other contractually narrow or limited purposes. 57 JOBS Act Accounting Election In April 2012, the JOBS Act was enacted.
We use the simplified method as prescribed by the SEC Staff Accounting Bulletin Topic 14, Share-Based Payment , to calculate the expected term for stock options, whereby, the expected term equals the midpoint of the weighted average remaining time to vest, vesting period and the contractual term of the options due to our lack of historical exercise data.
We generally use the simplified method as prescribed by the SEC Staff Accounting Bulletin Topic 14, Share-Based Payment , to estimate the expected term for stock options, whereby, the expected term equals the midpoint of the weighted average remaining time to vest, vesting period and the contractual term of the options due to our lack of historical exercise data.
We have also issued shares of our common stock in exchange for research and development services. General and Administrative Expenses Our general and administrative expenses primarily consist of salaries, advertising and promotion expenses, professional services fees, such as consulting, audit, accounting and legal fees, general corporate costs and allocated costs, including facilities, information technology and amortization of intangibles.
We have also issued shares of our common stock to vendors in exchange for research and development services. 47 General and Administrative Expenses Our general and administrative expenses primarily consist of salaries, advertising and promotion expenses, professional services fees, such as consulting, audit, accounting and legal fees, general corporate costs and allocated costs, including facilities, information technology and amortization of intangibles.
In November 2023, the FASB issued 2023-07, Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures, which expands annual and interim disclosure requirements for reportable segments, primarily through enhanced disclosures about significant segment expenses and segment profit or loss.
In November 2023, the FASB issued ASU 2023-07, Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures (“ASU 2023-07”) which expands annual and interim disclosure requirements for reportable segments, primarily through enhanced disclosures about significant segment expenses and segment profit or loss.
We plan to fund our operations through third party and related party debt/advances, private placement of restricted securities and the issuance of stock in a subsequent offering until such a time as we are able to generate profitable operations or a business combination may be achieved.
We plan to fund our operations through third party and related party debt/advances, private placement of restricted securities and the issuance of stock in a subsequent offering until such a time as the business achieves profitability or a business combination may be achieved.
Cost of Revenues, Gross Loss, and Gross Margin Cost of revenues associated with our products is primarily comprised of direct materials, manufacturing related costs incurred in the production process and inventory write-downs due to expiry.
Cost of Revenues, Gross Profit (Loss), and Gross Margin Cost of revenues associated with our products is primarily comprised of direct materials, shipping, manufacturing related costs incurred in the production process, serialization costs and inventory write-downs due to expiration.
We have elected to avail ourselves of this exemption and, therefore, we will not be subject to the same new or revised accounting standards as other public companies that are not emerging growth companies. 51 Recent Accounting Pronouncements The Financial Accounting Standards Board (the “FASB”) issues Accounting Standards Update (“ASUs”) to amend the authoritative literature in ASC.
We have elected to avail ourselves of this exemption and, therefore, we will not be subject to the same new or revised accounting standards as other public companies that are not emerging growth companies. Recent Accounting Pronouncements From time to time, the FASB issues Accounting Standards Update (“ASUs”) to amend the authoritative literature in the ASC.
For the year ended December 31, 2023, our U.S. pharmaceutical distributor accounted for 72% of our total net product sales and Kodatef sales to our Australian distributor accounted for 21% of total net product sales (46% and 39% for the year ended December 31, 2022, respectively).
For the year ended December 31, 2024, our U.S. pharmaceutical distributor accounted for 95% of our total net product sales and Kodatef sales to our Australian distributor accounted for 5% of total net product sales (72% and 21% for the year ended December 31, 2023, respectively).
The increase in net cash provided by financing activities is attributable to net proceeds of $6,454,325 generated from our IPO, which closed on July 14, 2023, as well as $1,131,771 received from the exercise of warrants, partially offset by repayments of certain of our outstanding debt obligations in July 2023.
Cash provided by financing activities for the year ended December 31, 2023 related to net proceeds of $6,454,325 generated from our IPO, which closed on July 14, 2023, as well as $1,131,771 received from the exercise of warrants, but partially offset by repayments of certain of our outstanding debt obligations in July 2023.
We expense all research and development costs in the period in which they are incurred. Payments made prior to the receipt of goods or services to be used in research and development are recognized as prepaid assets and expensed over the service period as the services are provided.
Payments made prior to the receipt of goods or services to be used in research and development are recognized as prepaid assets and expensed over the service period as the services are provided.
The loss for the year ended December 31, 2023 is related, in part to the exchange of the cumulative outstanding debt pursuant to the Knight Debt Conversion Agreement in January 2023, as well as losses recognized upon extinguishment of our interim bridge financing notes, all of which were settled or converted upon our IPO in July 2023.
The decrease is related, in part to the conversion of the cumulative outstanding debt pursuant to the Knight Debt Conversion Agreement in January 2023, which was accounted for as a debt extinguishment, as well as losses recognized upon extinguishment of our interim bridge financing notes, all of which were settled or converted upon our IPO in July 2023.
The consolidated financial statements for the years ended December 31, 2023, and December 31, 2022, respectively, included an explanatory note referring to our recurring operating losses and expressing substantial doubt in our ability to continue as a going concern.
The audited consolidated financial statements for the years ended December 31, 2024, and December 31, 2023, respectively, included an explanatory note referring to our recurring operating losses and expressing substantial doubt in our ability to continue as a going concern. Our future results are subject to substantial risks and uncertainties.
Derivative liabilities are adjusted to reflect fair value at each reporting period, with any increase or decrease in the fair value recorded in the results of operations (other income/expense) as change in fair value of derivative liabilities. We use a Monte Carlo Simulation Model to determine the fair value of these instruments.
Derivative liabilities are adjusted to reflect fair value at each reporting period, with any increase or decrease in the fair value recorded in the results of operations, as a component of other income or expense as change in fair value of derivative liabilities.
Change in Fair Value of Promissory Note For the year ended December 31, 2023, we recognized a net gain of $5,379,269 related to the change in the fair value of the promissory note with Knight, which was carried at fair value.
Change in Fair Value of Promissory Note For the year ended December 31, 2023, we recognized a net gain of $5,379,269 related to the change in the fair value of the Convertible Knight Loan, which was held at fair value beginning on the modification date in January 2023.
Cash Used in Investing Activities Net cash used in investing activities was $115,888 for the year ended December 31, 2023, as compared to $60,133 for the year ended December 31, 2022.
Cash Used in Investing Activities Net cash used in investing activities was $1,889,114 for the year ended December 31, 2024, as compared to $115,888 for the year ended December 31, 2023.
Change in Fair Value of Derivative Liabilities For the year ended December 31, 2023, we recognized a loss due to the change in fair value of derivative liabilities of $37,278 compared to $10,312 for the year ended December 31, 2022.
Change in Fair Value of Derivative Liabilities For the year ended December 31, 2024, we recognized a net gain on the change in fair value of derivative liabilities of $1,665,966 compared to a net loss of $37,278 for the year ended December 31, 2023.
The ASU must be applied retrospectively. We are currently evaluating the impact that ASU 2023-07 will have on our financial statement disclosures. In December 2023, the FASB issued ASU 2023-09, Income Taxes (ASC 740): Improvements to Income Tax Disclosures, which requires disaggregated information about a reporting entity’s effective tax rate reconciliation as well as information on income taxes paid.
The impact is limited to our financial statement disclosures, which are presented in Note 2 to the accompanying consolidated financial statements. In December 2023, the FASB issued ASU 2023-09, Income Taxes (ASC 740): Improvements to Income Tax Disclosures (“ASU 2023-09”) which requires disaggregated information about a reporting entity’s effective tax rate reconciliation as well as information on income taxes paid.
Compensation cost for service-based RSUs is based on the grant date fair value of the award, which is the closing market price of our common stock on the grant date multiplied by the number of shares awarded.
We recognize compensation expense for restricted stock units (“RSUs”) with only service-based vesting conditions on a straight-line basis over the vesting period. Compensation cost for service-based RSUs is based on the grant date fair value of the award, which is the closing market price of our common stock on the grant date multiplied by the number of shares awarded.
The decrease in interest expense is the result of the settlement or conversion of a majority of our outstanding debt obligations upon the closing of our IPO on July 14, 2023. Cash paid for interest was $179,117 and $2,193 for the years ended December 31, 2023 and December 31, 2022, respectively.
The decrease in interest expense is the result of the settlement or conversion of a majority of our outstanding debt obligations upon the closing of our IPO on July 14, 2023.
During the year ended December 31, 2023, we incurred initial costs related to our Phase II B clinical trial, which was then suspended in the fourth quarter of 2023.
Research and development costs incurred during the year ended December 31, 2023 consisted of initiation costs related to our Phase IIB COVID-19 clinical trial, which was later suspended in the fourth quarter of 2023.
Effect of Foreign Currency Translation on Cash Flow Our foreign operations were small relative to U.S. operations for the year ended December 31, 2023 and December 31, 2022, thus effects of foreign currency translation have been minor.
Effect of Foreign Currency Translation on Cash Flow Our foreign operations were small relative to U.S. operations for the years ended December 31, 2024 and December 31, 2023, thus effects of foreign currency translation have been minor. 6. Critical Accounting Policies, Significant Judgments, and Use of Estimates The preparation of financial statements in conformity with U.S.
(Loss) Gain on Debt Extinguishment For the year ended December 31, 2023, we recognized a $1,231,480 net loss on debt extinguishment, compared to a $120,683 net gain on debt extinguishment for the year ended December 31, 2022.
Loss on Debt Extinguishment For the year ended December 31, 2024, we did not recognize a gain or loss on debt extinguishment ($1,231,480 loss recognized during the year ended December 31, 2023).
Our net cash used in operating activities increased as a result of higher general and administrative expenses of $4,241,836 for the year ended December 31, 2023 ($1,303,722 for the year ended December 31, 2022), primarily related to higher legal, accounting, and professional fees, and investor-related outreach expenses preceding our IPO in July 2023.
Our net cash used in operating activities increased, in part due to higher general and administrative expenses of $5,024,985 for the year ended December 31, 2024 ($4,241,836 for the year ended December 31, 2023) primarily due to higher cash compensation and related expenses, legal and professional fees, insurance expenses, investor outreach expenses, and advertising and promotion expenses, as discussed above.
For awards that vest based on continued service, the service-based compensation cost is recognized on a straight-line basis over the requisite service period, which is generally the vesting period of the awards.
We measure compensation for all share-based payment awards granted to employees, directors, and nonemployees, based on the estimated fair value of the awards on the date of grant. For awards that vest based on continued service, the service-based compensation cost is recognized on a straight-line basis over the requisite service period, which is generally the vesting period of the awards.
Derivative Liabilities We assess the classification of our derivative financial instruments each reporting period, which formerly consisted of bridge shares, convertible notes payable, and certain warrants, and determined that such instruments qualified for treatment as derivative liabilities as they met the criteria for liability classification under ASC 815 (excluding certain warrants issued in connection with the IPO).
The corresponding cost is recognized as an immediate expense or a prepaid asset and expensed over the service period depending on the specific facts and circumstances of the agreement with the nonemployee. 56 Derivative Liabilities We assess the classification of our derivative financial instruments each reporting period, which formerly consisted of bridge shares, convertible notes payable, and certain warrants, and determined that such instruments initially qualified for treatment as derivative liabilities as they met the criteria for liability classification under ASC 815.
Interest and Other Income (Expense), Net Interest expense consists of interest accrued on our outstanding debt obligations and related amortization of debt discounts and deferred issuance costs. Other components of other income (expense) include changes in the fair value of financial instruments, gains and losses on extinguishments of debt, and other miscellaneous income (expense).
Other components of other income and expense include changes in the fair value of financial instruments, gains and losses on extinguishments of debt, and other miscellaneous income or expenses.
Liquidity and Capital Resources For the year ended December 31, 2023 and 2022, our net cash used in operating activities was $4,542,910 and $1,009,980, respectively and the cash balance was $2,142,485 as of December 31, 2023 ($264,865 as of December 31, 2022). To date, we have funded our operations through debt and equity financings.
Liquidity and Capital Resources As of December 31, 2024, we had cash and cash equivalents of $1,659,353 ($2,142,485 as of December 31, 2023). For the year ended December 31, 2024 and 2023, our net cash used in operating activities was $5,648,088 and $4,542,910, respectively.
Derivative Expense For the year ended December 31, 2023, we recognized $399,725 of derivative expense in connection with the raising of $555,000 in net proceeds from our bridge funding in May 2023. We recognized $504,613 of derivative expense during the year ended December 31, 2022 from the bridge funding raise in May 2022, generating $979,275 in net proceeds.
Cash paid for interest was $8,772 and $179,117 for the years ended December 31, 2024 and December 31, 2023, respectively. 51 Derivative Expense For the year ended December 31, 2023, we recognized $399,725 of derivative expense in connection with the raising of $555,000 in net proceeds from our bridge funding in May 2023.
In their audit report for the fiscal year ended December 31, 2023, our auditors have expressed their concern as to our ability to continue as a going concern. Our ability to continue as a going concern is dependent upon our ability to generate cash flows from operations and obtain financing.
Our ability to continue as a going concern is dependent upon our ability to generate cash flows from operations and obtain financing.
The ASU also requires entities with a single reportable segment to provide all segment disclosures under ASC 280, including the new required disclosures under the ASU. The ASU is effective for all public entities with fiscal years beginning after December 15, 2023, and interim periods within fiscal years beginning after December 15, 2024, with early adoption permitted.
ASU 2023-07 also requires entities with a single reportable segment to provide all segment disclosures under ASC 280, including the new required disclosures under the ASU. We adopted ASU 2023-07 on a retrospective basis for the 2024 annual period, and for interim periods beginning in 2025.
Critical Accounting Policies, Significant Judgments, and Use of Estimates The preparation of financial statements in conformity with United States generally accepted accounting principles requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosures of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period.
GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosures of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. Actual results could differ from those estimates.
We also earn research revenues from the Australian Tax Authority for research expenses conducted in Australia. The revenue was $42,250 for the year ended December 31, 2022 compared to $0 for the year ended December 31, 2023.
Our research revenues for the year ended December 31, 2024 primarily relate to research revenues earned from the Australian Tax Authority for research expenses conducted in Australia, and we earned $55,395 during the year ended December 31, 2024 ($0 during the year ended December 31, 2023).
We record a receivable for any amounts to be received pursuant to such sales. 49 Inventory We report inventories at the lower of cost or net realizable value. Cost is comprised of direct materials and, where applicable, costs we incur in bringing the inventories to their present location and condition. We use the Specific Identification method per lot.
Cost is comprised of direct materials and, where applicable, costs we incur in bringing the inventories to their present location and condition. We use the Specific Identification method per lot. A box price is calculated per lot number and sales are recognized by their lot number.
During the year ended December 31, 2023, $48,236 was recognized in other expense due to a one-time write off of an uncollectible receivable from our 3PL for an uninvoiced return.
As the development contract ended on August 31, 2022, additional storage revenue is not expected in the near future. Other expense during the year ended December 31, 2023, was primarily related to net foreign exchange transaction losses as well as a one-time write off of an uncollectible receivable from our 3PL for an uninvoiced return of $48,236. 52 5.
Despite higher write-offs, the Gross Margin % increased to (87.15)% for the year ended December 31, 2023 from (93.71)% for the year ended December 31, 2022. 45 Other Operating Revenues For the Year Ended December 31, Consolidated Statements of Operations Data: 2023 2022 $ Change % Change Research Revenues $ - $ 288,002 $ (288,002 ) (100.00 )% The research revenues earned by us were $0 for the year ended December 31, 2023, as compared to $288,002 for the year ended December 31, 2022.
Other Operating Revenues For the Year Ended December 31, Consolidated Statements of Operations Data: 2024 2023 $ Change % Change Research Revenues $ 73,771 $ - $ 73,771 N/A The research revenues earned by us were $73,771 for the year ended December 31, 2024, as compared to $0 for the year ended December 31, 2023.
We also earn research revenues from the Australian Tax Authority for qualified research activities conducted in Australia. 42 Operating Expenses Research and Development Research and development costs for the periods presented primarily consist of contracted R&D services and costs associated with preparation for our now halted COVID-19 clinical trial.
Operating Expenses Research and Development Research and development costs for the periods presented primarily consist of contracted R&D services and costs associated with preparation for and conducting our Babesiosis trial in 2024 and, in 2023, related to our halted COVID-19 clinical trial. We expense all research and development costs in the period in which they are incurred.
There have been a number of ASUs to date, that amend the original text of ASC. Management believes that those issued to date either (i) provide supplemental guidance, (ii) are technical corrections, (iii) are not applicable to us or (iv) are not expected to have a significant impact on our consolidated financial statements.
We regularly evaluate new ASUs to determine the impact that these pronouncements may have on our consolidated financial statements. Other than the pronouncements listed below, management believes that those issued to date either (i) provide supplemental guidance, (ii) are technical corrections, or (iii) are not applicable to our consolidated financial statements or related disclosures.
For the year ended December 31, 2022, 570 boxes were sold to pharmacies and dispensaries. Sales volume increased by 186% to 1,632 boxes sold to pharmacies and dispensaries for the year ended December 31, 2023.
Arakoda entered the U.S. civilian supply chain in the third quarter of 2019. For the year ended December 31, 2023, 1,632 boxes were sold to pharmacies and dispensaries. Sales volume increased by 214% to 5,119 boxes sold to pharmacies and dispensaries for the year ended December 31, 2024.
Components of Results of Operations Product Revenues – net of Discounts and Rebates To date, we have received the majority of our product revenues from sales of our Arakoda™ product to the US Department of Defense (the “DoD”) and resellers in the U.S. and abroad.
Components of Results of Operations Product Revenues - net of Discounts and Rebates We receive the majority of our product revenues from sales of our Arakoda product to resellers in the U.S. and abroad. Foreign sales to both Australia and Europe are further subject to profit sharing agreements for boxes sold to customers.
We charge any write-downs of inventories to Cost of Revenues in the Consolidated Statements of Operations and Comprehensive Loss. Share-Based Payments We measure compensation for all share-based payment awards granted to employees, directors, and nonemployees, based on the estimated fair value of the awards on the date of grant.
We charge any write-downs of inventories to Cost of Revenues in the Consolidated Statements of Operations and Comprehensive Loss. Share-Based Payments We account for share-based payments in accordance with ASC Subtopic 718, Compensation - Stock Compensation (“ASC 718”).
However, we cannot assure you that we will be able to raise additional capital on acceptable terms, or at all. Going Concern As of December 31, 2023, we had an accumulated deficit of $32,580,850.
However, we cannot assure you that we will be able to raise additional capital on acceptable terms, or at all. Going Concern In their audit report for the fiscal year ended December 31, 2024, our auditors have expressed their concern as to our ability to continue as a going concern.
Equity or liability instruments that become subject to reclassification under ASC Topic 815 are reclassified at the fair value of the instrument on the reclassification date. 50 Income Taxes From January 1, 2022 to May 31, 2022, 60 Degrees Pharmaceuticals, LLC was a C-corporation for income tax purposes before the incorporation/merger into 60 Degrees Pharmaceuticals, Inc. on June 1, 2022.
Equity or liability instruments that become subject to reclassification under ASC Topic 815 are reclassified at the fair value of the instrument on the reclassification date.
The rebate associated with PBMs ranges from 30 to 41.25% (15 to 39.75% in 2022) depending on the amount of coverage provided. For the year ended December 31, 2023, discounts and rebates were $216,031 compared to $59,552 for the year ended December 31, 2022. Arakoda entered the U.S. civilian supply chain in the third quarter of 2019.
Lastly, we have relationships with several large pharmacy benefit managers (“PBMs”) that allow patients to purchase Arakoda at a discount. The rebate associated with PBMs ranges from 30% to 41.25% depending on the amount of coverage provided. For the year ended December 31, 2024, discounts and rebates were $476,218 compared to $216,031 for the year ended December 31, 2023.
Based on current internal projections, taking into consideration the net proceeds of approximately $1.9 million received in connection with the offering completed in January 2024, recent growth in Arakoda sales, and preparatory clinical trial activities, we estimate that we will have sufficient funds to remain viable through October 31, 2024.
Based on current internal projections, taking into consideration the net proceeds of approximately $1.9 million received under the ATM Agreement, an additional $5.127 million in cumulative net proceeds received from the September, 2024 Private Placement and 2025 offerings, and recent growth in Arakoda sales, we estimate that we will have sufficient funds to remain viable through August 31, 2025, excluding the additional costs of conducting the expanded access study for chronic babesiosis patients (currently being planned), and assuming no additional capital raises.
Cost of Revenues, Gross Loss, and Gross Margin Cost of revenues was $474,550 for the year ended December 31, 2023, as compared to $432,370 for the year ended December 31, 2022.
Cost of Revenues, Gross Profit (Loss), and Gross Margin Cost of revenues was $384,765 for the year ended December 31, 2024, as compared to $474,550 for the year ended December 31, 2023. While net product sales increased over the same periods, the decrease in cost of goods sold is primarily attributable to the fixed part of cost of goods.
This condition, among others, raises substantial doubt about our ability to continue as a going concern for one year from the date these financial statements are issued. In view of these matters, continuation as a going concern is dependent upon our ability to meet financial requirements, raise additional capital, and achieve gross profitability from our single marketed product.
However, there can be no assurance that we will ever achieve or maintain profitability. These conditions, among others, raise substantial doubt about our ability to continue as a going concern for one year from the date these financial statements are issued.
The risk-free interest rate is based on U.S. Treasury securities with a maturity date commensurate with the expected term of the associated award. The expected dividend yield is assumed to be zero as we have never paid dividends and have no current plans to pay any dividends on our common stock.
The expected dividend yield is assumed to be zero as we have never paid dividends and have no current plans to pay any dividends on our common stock. The assumptions used in calculating the fair value of share-based awards represent our best estimates and involve inherent uncertainties and the application of significant judgment.
Operating Expenses For the Year Ended December 31, Consolidated Statements of Operations Data: 2023 2022 $ Change % Change Research and Development $ 691,770 $ 525,563 $ 166,207 31.62 % General and Administrative Expenses 4,241,836 1,303,722 2,938,114 225.36 Total Operating Expenses $ 4,933,606 $ 1,829,285 $ 3,104,321 169.70 % Research and Development Research and development costs increased during the year ended December 31, 2023 when compared to the year ended December 31, 2022.
Operating Expenses For the Year Ended December 31, Consolidated Statements of Operations Data: 2024 2023 $ Change % Change Research and Development $ 4,986,526 $ 691,770 $ 4,294,756 620.84 % General and Administrative Expenses 5,024,985 4,241,836 783,149 18.46 Total Operating Expenses $ 10,011,511 $ 4,933,606 $ 5,077,905 102.92 % 50 Research and Development Research and development costs increased during the year ended December 31, 2024 when compared to the year ended December 31, 2023.
Contractual Obligations The following table summarizes our contractual obligations as of December 31, 2023: Payments Due By Period Total Less than 1 year 1-3 years 3-5 years More than 5 Years Principal obligations on the debt arrangements $ 150,000 $ - $ 683 $ 6,570 $ 142,747 Interest obligations on the debt arrangements 112,892 8,772 16,861 10,974 76,285 Operating leases 13,650 13,650 - - - Accounts payable and accrued expenses 506,206 506,206 - - - Total $ 782,748 $ 528,628 $ 17,544 $ 17,544 $ 219,032 Amounts related to contingent milestone payments are not considered contractual obligations as they are contingent on the achievement of certain milestones.
The accompanying financial statements have been prepared on a going concern basis, which contemplates the realization of assets and the satisfaction of obligations in the normal course of business, and do not include any adjustments to the amount and classification of assets and liabilities that may be necessary should we be unable to continue as a going concern. 53 Contractual Obligations The following table summarizes our contractual obligations as of December 31, 2024: Payments Due By Period Total Less than 1 year 1-3 years 4-5 years More than 5 Years Principal obligations on the debt arrangements $ 150,000 $ - $ 3,621 $ 6,799 $ 139,580 Interest obligations on the debt arrangements 104,797 8,772 13,923 10,746 71,356 Accounts payable and accrued expenses 1,007,618 1,007,618 - - - Total $ 1,262,415 $ 1,016,390 $ 17,544 $ 17,545 $ 210,936 Amounts related to contingent milestone payments are not considered contractual obligations as they are contingent on the achievement of certain milestones.
We had been accruing anticipated research rebates quarterly but after the COVID-19 research cancellation, in the fourth quarter of 2023, we made the decision not to file for the research rebate and reversed the previously accrued revenues and charged them to research and development.
We did not earn research revenues from the Australian Tax Authority in 2023 due to the cancellation of our COVID-19 trial, after which we made the decision not to file for the research rebate.
The accompanying financial statements are prepared on a going concern basis, which contemplates the realization of assets and the satisfaction of obligations in the normal course of business. However, we have not demonstrated the ability to generate enough revenues to date to cover operating expenses and have accumulated losses to date.
Since our inception, we have not demonstrated the ability to generate enough revenues to date to cover operating expenses and we have accumulated losses to date.
Direct COVID-19-related trial costs are 83% of the costs for the year ended December 31, 2023 at $574,609 and 49% of the costs at $256,581 for the year ended December 31, 2022. General and Administrative Expenses For the year ended December 31, 2023, our general and administrative expenses increased by 225.36% or $2,938,114 from the year ended December 31, 2022.
Direct COVID-19-related trial costs represent less than 1% of the total research and development costs for the year ended December 31, 2024 at $16,247 and 83% of the costs for the year ended December 31, 2023 at $574,609.
Arakoda sales to our distributor Scandinavian Biopharma in Europe for the year ended December 31, 2023 were $18,000 ($18,000 for the year ended December 31, 2022). The distributor has also reported increased interest from consumers in Europe seeking treatment for Babesiosis.
Arakoda sales volume is also showing signs of sales growth in Europe. We first shipped Arakoda to our distributor Scandinavian Biopharma (“SB”) in September 2022. For the year ended December 31, 2024, SB reported 147 boxes sold (0 for the year ended December 31, 2023). According to our distributor, this is due to greater interest in treating babesiosis.
Our cumulative debt outstanding with Knight was not measured at fair value on a recurring basis prior to the Knight Debt Conversion Agreement executed in January 2023, hence we recorded a $0 change in fair value for the year ended December 31, 2022. 47 Other Expenses, net For the year ended December 31, 2023, we recognized $83,116 in other expenses compared to $43,238 for the year ended December 31, 2022.
We no longer have any debt obligations measured at fair value on a recurring basis, hence we recorded a $0 change in fair value for the year ended December 31, 2024.
(1,485.06 )% (2,769.49 )% Comparison of the Years Ended December 31, 2023, and 2022 Product Revenues - net of Discounts and Rebates, Service Revenues, Cost of Revenues, Gross Loss, and Gross Margin For the Year Ended December 31, Consolidated Statements of Operations Data: 2023 2022 $ Change % Change Product Revenues – net of Discounts and Rebates $ 253,573 $ 192,913 $ 60,660 31.44 % Service Revenues - 30,295 (30,295 ) (100.00 ) Product and Service Revenues, net 253,573 223,208 30,365 13.60 Cost of Revenues 474,550 432,370 42,180 9.76 Gross Loss $ (220,977 ) $ (209,162 ) $ (11,815 ) 5.65 % Gross Margin % (87.15 )% (93.71 )% 44 Product Revenues - net of Discounts and Rebates Our product revenues – net of discounts and rebates were $253,573 for the year ended December 31, 2023, as compared to $192,913 for the year ended December 31, 2022.
Comparison of the Years Ended December 31, 2024, and 2023 Product Revenues - net of Discounts and Rebates, Cost of Revenues, Gross Profit (Loss), and Gross Margin For the Year Ended December 31, Consolidated Statements of Operations Data: 2024 2023 $ Change % Change Product Revenues – net of Discounts and Rebates $ 607,574 $ 253,573 $ 354,001 139.61 % Cost of Revenues 384,765 474,550 (89,785 ) (18.92 ) Gross Profit (Loss) $ 222,809 $ (220,977 ) $ 443,786 (200.83 )% Gross Margin % 36.67 % (87.15 )% Product Revenues - net of Discounts and Rebates Our product revenues - net of discounts and rebates were $607,574 for the year ended December 31, 2024, as compared to $253,573 for the year ended December 31, 2023.
The increase in cash used in investing activities is primarily attributable to higher purchases of property and equipment of $57,623 for the year ended December 31, 2023, as compared to $0 for the year ended December 31, 2022.
The increase in cash used in investing activities is primarily driven by purchases of short-term certificates of deposit for a total cost of $1,708,000 during the year ended December 31, 2024 ($0 during the year ended December 31, 2023), purchased for the purposes of earning interest income.
Additionally, during the year ended December 31, 2023, we incurred $969,581 in accounting, audit, legal and professional fees, $304,581 of insurance expenses, and $668,639 of investor-related outreach expenses (up from $656,089, $84,879, and $142 for the year ended December 31, 2022, respectively). 46 Interest and Other Income (Expense), Net For the Year Ended December 31, Consolidated Statements of Operations Data: 2023 2022 $ Change % Change Interest Expense $ (2,286,637 ) $ (3,989,359 ) $ 1,702,722 (42.68 )% Derivative Expense (399,725 ) (504,613 ) 104,888 (20.79 ) Change in Fair Value of Derivative Liabilities (37,278 ) (10,312 ) (26,966 ) 261.50 (Loss) Gain on Debt Extinguishment (1,231,480 ) 120,683 (1,352,163 ) (1,120.43 ) Change in Fair Value of Promissory Note 5,379,269 - 5,379,269 N/A Other Expenses, net (83,116 ) (43,238 ) (39,878 ) 92.23 Total Interest and Other Income (Expense), net $ 1,341,033 $ (4,426,839 ) $ 5,767,872 (130.29 )% Interest Expense For the year ended December 31, 2023, we recognized $2,286,637 of interest expense ($3,989,359 for the year ended December 31, 2022).
Interest and Other Income (Expense), Net For the Year Ended December 31, Consolidated Statements of Operations Data: 2024 2023 $ Change % Change Interest Expense $ (7,912 ) $ (2,286,637 ) $ 2,278,725 (99.65 )% Derivative Expense - (399,725 ) 399,725 (100.00 ) Change in Fair Value of Derivative Liabilities 1,665,966 (37,278 ) 1,703,244 (4,569.03 ) Loss on Debt Extinguishment - (1,231,480 ) 1,231,480 (100.00 ) Change in Fair Value of Promissory Note - 5,379,269 (5,379,269 ) (100.00 ) Other Income (Expense), net 101,464 (83,116 ) 184,580 (222.08 ) Total Interest and Other Income (Expense), net $ 1,759,518 $ 1,341,033 $ 418,485 31.21 % Interest Expense For the year ended December 31, 2024, we recognized $7,912 of interest expense ($2,286,637 for the year ended December 31, 2023).
We have not included any of these amounts in the table above as we cannot estimate or predict when, or if, these amounts will become due. 48 Cash Flows Year Ended December 31, 2023 2022 $ Change % Change Net Cash Provided By (Used In): Operating Activities $ (4,542,910 ) $ (1,009,980 ) $ (3,532,930 ) 349.80 % Investing Activities (115,888 ) (60,133 ) (55,755 ) 92.72 Financing Activities 6,474,565 1,221,706 5,252,859 429.96 Effect of Foreign Currency Translation on Cash Flow 61,853 (2,127 ) 63,980 (3,007.99 ) Net Increase in Cash $ 1,877,620 $ 149,466 $ 1,728,154 1,156.22 % Cash Used in Operating Activities Net cash used in operating activities was $4,542,910 for the year ended December 31, 2023, as compared to $1,009,980 for the year ended December 31, 2022.
Cash Flows Year Ended December 31, 2024 2023 $ Change % Change Net Cash (Used In) Provided By : Operating Activities $ (5,648,088 ) $ (4,542,910 ) $ (1,105,178 ) 24.33 % Investing Activities (1,889,114 ) (115,888 ) (1,773,226 ) 1,530.12 Financing Activities 7,053,571 6,474,565 579,006 8.94 Effect of Foreign Currency Translation on Cash Flow 499 61,853 (61,354 ) (99.19 ) Net (Decrease) Increase in Cash and Cash Equivalents $ (483,132 ) $ 1,877,620 $ (2,360,752 ) (125.73 )% Cash Used in Operating Activities Net cash used in operating activities was $5,648,088 for the year ended December 31, 2024, as compared to $4,542,910 for the year ended December 31, 2023.
The increase in cost of goods sold is in part, due to the 31.44% increase in product sales over the same periods, as well as higher write-offs for expired inventory, which increased to $191,111 for the year ended December 31, 2023 (up from $162,222 for the year ended December 31, 2022).
As the sales volume has increased, the gross margin has improved as the variable cost of goods of each unit sold is substantially less than the sales price. Additionally, write-downs for expired inventory were significantly higher during the year ended December 31, 2023 at $191,111, as compared to $22,046 during the year ended December 31, 2024.
Cash Provided by Financing Activities Net cash provided by financing activities was $6,474,565 for the year ended December 31, 2023, as compared to $1,221,706 for the year ended December 31, 2022.
Additionally, purchases of computer and lab equipment totaled $103,773 during the year ended December 31, 2024 ($57,623 during the year ended December 31, 2023), and capitalized website development costs and patent costs totaled $25,374 and $51,967, respectively, for the year ended December 31, 2024 ($18,283 and $39,982 for the year ended December 31, 2023, respectively). 54 Cash Provided by Financing Activities Net cash provided by financing activities was $7,053,571 for the year ended December 31, 2024, as compared to $6,474,565 for the year ended December 31, 2023.
The product is then transferred usually to one of the three large U.S. pharmaceutical distributors where rebates are 10%. Lastly, we have relationships with several large pharmacy benefit managers (“PBMs”) that allow patients to purchase Arakoda at a discount.
Discounts and rebates offered to our 3PL partner amount to 12% (lower rates available upon reaching larger revenue tiers) along with a $5,500 fixed monthly fee that started in 2023. The product is then transferred usually to one of the three large U.S. pharmaceutical distributors where rebates are 10%.
Sales to Biocelect are currently subject to a profit share distribution once the original transfer price has been recouped. As of December 31, 2023, no profit share has been due to us ($0 as of December 31, 2022), though we did settle the historical profit share through September 30, 2022 for $24,486 (AUD$35,000) on January 16, 2023.
Sales to Biocelect are currently subject to a profit share distribution once the original transfer price has been recouped. The most recent sale of boxes to Biocelect reached profit share at the end of Q1 2024.
Removed
Foreign sales to both Australia and Europe are further subject to profit sharing agreements for boxes sold to customers. Currently, the procurement contract with the DoD has expired and DoD sales last happened in 2021.
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Overview We are a specialty pharmaceutical company with a goal of using cutting-edge biological science and applied research to further develop and commercialize new therapies for the prevention and treatment of infectious diseases. We have successfully achieved regulatory approval of Arakoda® (“Arakoda”), a malaria preventative treatment that has been on the market since late 2019.
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Other Operating Revenues Our research revenues have historically been derived mostly from a single, awarded research grant in the amount of $4,999,814 at the beginning of December 2020 (with an additional $720,000 awarded February 26, 2021) from the Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense (which may be referred to as “JPEO”) to study Arakoda in mild-to-moderate COVID-19 patients.
Added
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. 46 Following our initial public offering in July 2023, our initial strategic priority was to conduct a Phase IIB study that would have evaluated the potential of the Arakoda regimen of Tafenoquine to accelerate disease recovery in COVID-19 patients with low risk of disease progression.
Removed
A majority of the study was completed in 2021 with the planned lab data analysis and the submission of the final study report completed during the first nine months of 2022. Research revenue was recognized when research expenses against the JPEO grant were recognized at the end of each month.
Added
In October 2023, we made a decision to suspend this study. This was a consequence of advice previously received from the U.S.
Removed
Research revenues do not exceed directly related research expenses for a given period as the grant did not cover additional research beyond the scope of COVID-19.
Added
Food and Drug Administration (FDA), which we interpreted to mean that the agency would not have granted clearance for the study to proceed unless we redesigned it to (i) enroll a patient population in which receipt of Paxlovid or Lagevrio would be medically contraindicated, or (ii) compare Tafenoquine to placebo in patients taking a “standard of care” regimen (defined by the FDA as Lagevrio or Paxlovid).
Removed
We now have interest income as a result of the IPO as certain cash proceeds are invested in Federal Deposit Insurance Corporation backed interest bearing accounts.
Added
The FDA’s position was somewhat surprising given that neither Paxlovid nor Lagevrio is indicated for treatment of COVID-19 in low-risk patients. We determined that conducting our study in an alternate population in the United States would be unfeasible, and that conducting an add-on-to standard of care study might not be Phase III enabling.
Removed
The increase in product sales is primarily due to increased sales volume during the period and was partially offset by the reduction of our wholesale acquisition cost (sales price) of Arakoda™ (16 x 100 mg tablets) from $285 to $235 per box in January 2023. We offer discounts and rebates to the civilian U.S. supply chain distribution channel.
Added
Accordingly, we made a decision to pivot back to continue commercialization of Arakoda for malaria, and further evaluation of the Arakoda regimen of Tafenoquine for babesiosis and other diseases. We believe such an approach is both less risky and less expensive.
Removed
We record sales when our 3PL partner transfers boxes into their title model. Discounts and rebates are offered to our 3PL partner amounting to 12% along with a fixed monthly fee that started in 2023 (2% and no fixed fee in 2022).
Added
Moving forward, our general strategy to achieve profitability and grow shareholder value has three facets: (i) increase sales of Arakoda; (ii) conduct clinical trials to expand the number of patients who can use Tafenoquine for new indications in the future; and (iii) reposition small molecule therapeutics with good clinical safety profiles for new indications. 2.
Removed
This growth in sales volumes is a combination of natural organic growth, the reduction in the wholesale acquisition cost of $285 per box to $235 per box effective January 2023, and increased prescribing by doctors of Arakoda off-label for usage treatment of babesiosis.

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