60 DEGREES PHARMACEUTICALS, INC.
For the period ended Dec 31, 2025. Filed Mar 30, 2026.
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A company's yearly report to the SEC, with audited financial statements. It is the fullest account a company gives of its business, its finances and the risks it sees.
FY2025 · Filed Mar 30, 2026
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What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-K
Period ended 2024-12-31; filed 2025-03-27.
0001013762-25-003343
Item 7. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-K
Period ended 2025-12-31; filed 2026-03-30.
0001554855-26-000467
Item 7. Management’s Discussion and Analysis of Financial Condition and Results of OperationsThe baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.
Compared 103 previous paragraphs and 99 current paragraphs.
67 unchanged; 24 reworded; 8 added; 12 removed; 0 previous and 0 current paragraphs rearranged.
Tables are not compared: 8 previous and 8 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.
A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.
Added paragraphs (8)
Current report
Cost of Revenues, Gross Profit, and Gross Margin
Current report
Cost of Revenues, Gross Profit, and Gross Margin
Current report
Cost of revenues was $781,695 for the year ended December 31, 2025, as compared to $384,765 for the year ended December 31, 2024. The increase in cost of revenues was, in part, due to higher product sales during the year, as well as higher write-offs of inventory not expected to be sold prior to its expiration date. Write-offs for expiring inventory were $445,181 during the year ended December 31, 2025, as compared to $22,046 during the year ended December 31, 2024. The excess inventory resulted from our strategic decision to validate a new, larger-scale production method with then soon to be expiring raw materials (API), with the offsetting assistance from our USAMMDA grant. The development proved successful but the dating on the produced inventory is already considered in the industry to be short-dated and will have to be replaced by the beginning of the second quarter of 2026. The temporary increase in inventory write-offs was a necessary step in scaling our operations and is not expected to be recurring. Our new larger-scale production processes are expected to help keep inventory costs lower than otherwise. Due to these factors, the Gross Margin % decreased from 36.67% for the year ended December 31, 2024 to 22.26% for the year ended December 31, 2025.
Current report
Kentucky for tafenoquine clinical trial supply. We recognized research revenues of $298,868 related to the USAMMDA grant for the year ended December 31, 2025 ($12,994 for the year ended December 31, 2024). We recognized research revenues of $89,302 from the University of Kentucky for the year ended December 31, 2025 ($0 for the year ended December 31, 2024). Other research revenues were $15,454 for the year ended December 31, 2025 ($60,777 for the year ended December 31, 2024).
Current report
For the year ended December 31, 2025, we recognized $131,970 in other income compared to $101,464 in other income for the year ended December 31, 2024. We recognized interest income of $104,360 during the year ended December 31, 2025 ($103,299 during the year ended December 31, 2024). Other income for the year ended December 31, 2024 also included $10,789 of storage revenue recognized in association with final payment under the legacy contract with the USAMMDA for storing Arakoda purchases. We did not recognize storage revenue for the year ended December 31, 2025.
Current report
We also received lower proceeds from the exercise of warrants at $2,804 for the year ended December 31, 2025, compared to $10,963 for the year ended December 31, 2024. Additionally, for the year ended December 31, 2025, we withheld shares valued at $18,000 to cover tax withholdings for net share settlement of certain 2024 performance bonuses awarded to our executives ($0 for the year ended December 31, 2024).
Current report
In September 2025, the FASB issued ASU 2025-06, Intangibles - Goodwill and Other - Internal-Use Software (Subtopic 350-40): Targeted Improvements to the Accounting for Internal-Use Software(“ASU 2025-06”), which amends certain aspects of the accounting for and disclosure of software costs under ASC 350-40. The amendments modernize the recognition and disclosure framework for internal-use software costs, removing the previous “development stage” model and introducing a more judgment-based approach. The ASU is effective for all entities for interim and annual periods beginning after December 15, 2027, with early adoption permitted. We are currently evaluating the impact that ASU 2025-06 will have on our consolidated financial statements.
Current report
In September 2025, the FASB issued ASU 2025-07, Derivatives Scope Refinements and Scope Clarification for Share-Based Noncash Consideration from a Customer in a Revenue Contract (“ASU 2025-07”). ASU 2025-07 adds a new scope exception from derivative accounting under ASC 815 for certain non-exchange-traded contracts with customers with an underlying that is based on operations or activities specific to one of the parties to the contract. Further, ASU 2025-07 clarifies that an entity should apply the guidance in ASC 606 to a contract with stock-based noncash consideration. The ASU is effective for annual periods beginning after December 15, 2026 and interim periods within those annual periods, with early adoption permitted. We are currently evaluating the impact that ASU 2025-06 will have on our consolidated financial statements.
Removed paragraphs (12)
Previous report
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. In October 2023, we made a decision to suspend this study. This was a consequence of advice previously received from the U.S. 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). 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. 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.
Previous report
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.
Previous report
Cost of Revenues, Gross Profit (Loss), and Gross Margin
Previous report
Cost of Revenues, Gross Profit (Loss), and Gross Margin
Previous report
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. 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. Due to these factors, the Gross Margin % increased significantly from (87.15%) for the year ended December 31, 2023 to 37.78% for the year ended December 31, 2024.
Previous report
Derivative Expense
Previous report
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 record derivative expense when the initial fair value of the related derivative liabilities exceeds the cash proceeds received. We did not record derivative expense for the year ended December 31, 2024 as we did not complete any debt financing transactions during the period.
Previous report
Loss on Debt Extinguishment
Previous report
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). 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 net amount for the year ended December 31, 2023 was partially offset by a debt extinguishment gain of $223,077 recognized on conversion of the Xu Yu promissory note on the date of our IPO.
Previous report
Change in Fair Value of Promissory Note
Previous report
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. The gain relates to the mark to market adjustment recognized immediately prior to the automatic conversion of the outstanding debt obligation into our equity shares upon the closing of our IPO. 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.
Previous report
For the year ended December 31, 2024, we recognized $101,464 in other income compared to $83,116 in other expense for the year ended December 31, 2023. As a result of the IPO as well as additional equity financing transactions completed in 2024, we have earned higher interest income from investing certain cash proceeds in interest-bearing accounts and short-term certificates of deposit. We recognized interest income of $103,299 during the year ended December 31, 2024 ($19,985 during the year ended December 31, 2023). Additionally, during the year ended December 31, 2024, we recognized $10,789 in service revenue in association with the final payment from the USAMMDA for storing Arakoda purchases ($0 for the year ended December 31, 2023), upon the final resolution of storage fees payable from the USAMMDA under the original development contract entered into in 2014. 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.
Reworded paragraphs (24)
Previous wording
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. 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.
Current wording
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. Currently,60 P’s pipeline under development covers development programs for vector-borne, fungal, and viral diseases utilizing three of the Company’s future products: (i) new products that contain the Arakoda regimen of Tafenoquine; (ii) new products that contain Tafenoquine; and (iii) Celgosivir and/or botanical extracts from Australian Chestnut Trees.
Previous wording
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. Sales to resellers in the US are subject to considerable discounts and rebates for services provided by our third-party logistics (“3PL”) partner and wholesalers and pharmacy benefit managers (“PBMs”).
Current wording
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 were further subject to profit sharing agreements for boxes sold to customers. Sales to resellers in the US are subject to considerable discounts and rebates for services provided by our third-party logistics (“3 PL”) partner and wholesalers and pharmacy benefit managers (“PBMs”).
Previous wording
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. 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. We have also issued shares of our common stock to vendors in exchange for research and development services.
Current wording
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. 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. We have also issued shares of our common stock to vendors in exchange for research and development services
Previous wording
Prior to the IPO, our interest expense consisted of interest accrued on our outstanding debt obligations and amortization of debt discounts and deferred issuance costs. Subsequently, interest expense is mostly limited to a single, $150,000 SBA loan. 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. We also earn interest income from cash invested in interest-bearing accounts, as well as cash equivalents and short-term investments consisting of certificates of deposits with original maturities ranging from three to six months.
Current wording
We earn interest income from cash invested in interest-bearing accounts, as well as cash equivalents and short-term investments consisting of certificates of deposits with original maturities ranging from three to six months. Interest expense for the periods presented is limited to a single $150,000 SBA loan that bears interest at 3.75%. Other components of other income (expense) include changes in the fair value of derivative liabilities and other miscellaneous income or expenses.
Previous wording
Product Revenues - net of Discounts and Rebates, Cost of Revenues, Gross Profit (Loss), and Gross Margin
Current wording
Product Revenues - net of Discounts and Rebates, Cost of Revenues, Gross Profit, and Gross Margin
Previous wording
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. 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). Domestic commercial product sales are primarily driving increased sales volume during the period.
Current wording
Our product revenues - net of discounts and rebates were $1,005,471 for the year ended December 31, 2025, as compared to $607,574 for the year ended December 31, 2024. For the year ended December 31, 2025, our U.S. pharmaceutical distributor accounted for 92% of our total net product sales and Kodatef sales to our Australian distributor accounted for 6% of total net product sales (95% and 5% for the year ended December 31, 2024, respectively). Despite a shortage of Arakoda 16-ct boxes starting in April 2025, which resulted from a delay in completing commercial validation of a new packaging format, domestic, commercial product sales increased during the period, primarily due to the combination of rising sales, price increases and fewer returns.
Previous wording
We offer discounts and rebates to the civilian U.S. supply chain distribution channel. We record sales when our 3PL partner transfers boxes into their title model. 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%. 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.
Current wording
We offer discounts and rebates to the civilian U.S. supply chain distribution channel. We record sales when our 3 PL partner transfers boxes into their title model. Discounts and rebates offered to our 3 PL partner amount to 12% (lower rates available upon reaching larger revenue tiers) along with a $5,500 fixed monthly fee. 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. The rebate associated with PBMs ranges from 30% to 41.25% depending on the amount of coverage provided. For the year ended December 31, 2025, discounts and rebates were $476,430 compared to $476,218 for the year ended December 31, 2024.
Previous wording
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. Based on IQVIA data, this growth in sales volume appears to be driven primarily by organic growth in the Lyme disease community, whose prescribers utilize Arakoda for treatment of babesiosis.
Current wording
Arakoda entered the U.S. civilian supply chain in the third quarter of 2019. Since the introduction of the new 8-ct bottle in June 2025, we will be reporting Arakoda unit sales in terms of 16-ct box equivalents. For the year ended December 31, 2024,5,119 16-ct box equivalents were sold to pharmacies and dispensaries. Sales volume increased by 12% to 5,724 16-ct box equivalents sold to pharmacies and dispensaries for the year ended December 31, 2025.
Previous wording
Kodatef sales to our distributor Biocelect in Australia for the year ended December 31, 2024 were $30,652 ($53,718 for the year ended December 31, 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. Biocelect reported approximately 105% year-over-year growth, the equivalent of 1,850 boxes sold for the year ended December 31, 2024, compared to 903 boxes for the year ended December 31, 2023. As of December 31, 2024, Biocelect’s unsold inventory that remains subject to profit share was the equivalent of 385 boxes. While growth in Australia is similarly positive to that in the US, Biocelect has achieved that growth by competing directly with Malarone in terms of price in their market for the approved antimalarial prophylaxis indication. As of December 31, 2024, $9,444 of profit share was due to us ($0 as of December 31, 2023).
Current wording
Kodatef sales to our distributor Biocelect in Australia for the year ended December 31, 2025 were $57,058 ($30,652 for the year ended December 31, 2024). A historical portion of sales to Biocelect remained subject to a profit share distribution once the original transfer price has been recouped. As of December 31, 2025, Biocelect has no inventory left that remains subject to profit share. Biocelect, which acts as a distributor in the Australian and New Zealand markets, reported year-over-year growth of <1%, with 1,854 boxes sold for the year ended December 31, 2025, compared to 1,850 boxes for the year ended December 31, 2024. Additionally, under a new agreement executed during 2025, Biocelect began to purchase from the latest manufactured lot of Kodatef at $49.50 AUD per box which are not subject to historical profit share. As of December 31, 2025, no receivables were due to us ($9,444 as of December 31, 2024).
Previous wording
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.
Current wording
Arakoda sales volume in Europe continues to grow. We first shipped Arakoda to our distributor Scandinavian Biopharma (“SB”) in September 2022. For the year ended December 31, 2025, SB reported 353 boxes sold (147 for the year ended December 31, 2024). According to our distributor, this is due to greater interest in treating babesiosis. Additionally, we recorded $22,500 in European sales for the year ended December 31, 2025 ($0 for the year ended December 31, 2024).
Previous wording
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. 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 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. In 2024, we also began to recognize research revenues related to the new USAMMDA contract we were awarded in July 2024 to facilitate commercial validation of a new bottle and replacement blister packaging of Arakoda.
Current wording
The research revenues earned by us were $403,624 for the year ended December 31, 2025, as compared to $73,771 for the year ended December 31, 2024. The increase in research revenues is due to the new USAMMDA contract we were awarded in July 2024 to facilitate commercial validation of a new bottle and replacement blister packaging of Arakoda and the contract we signed with the University of
Previous wording
Research and development costs increased during the year ended December 31, 2024 when compared to the year ended December 31, 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. 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. During the year ended December 31, 2024, $3,225,000, or 65% of the total research and development costs, relate to share-based payments granted to two vendors in January 2023, which payments were initially deferred and capitalized. Kentucky Technology, Inc. delivered us a report on the potential development of SJ733 + tafenoquine in the second quarter of 2024 and Trevally completed the synthesis of 8.8 kilograms of castanospermine in the third quarter of 2024, resulting in $2,625,000 and $600,000, respectively, of research and development expense recognized for the year ended December 31, 2024. We also incurred $1,359,532 in costs related to our babesiosis trial for tafenoquine during the year ended December 31, 2024 ($0 during the year ended December 31, 2023).
Current wording
Research and development costs decreased by $2,880,370 during the year ended December 31, 2025 when compared to the year ended December 31, 2024. The decline is primarily attributable to non-cash charges totaling $3,225,000 recognized during the year ended December 31, 2024 related to share-based payments issued to vendors in January 2023 as advance consideration, which payments were initially deferred and capitalized. Kentucky Technology, Inc. delivered us a report on the potential development of SJ733 + tafenoquine in the second quarter of 2024 and Trevally completed the synthesis of 8.8 kilograms of castanospermine in the third quarter of 2024, resulting in $2,625,000 and $600,000, respectively, of research and development expense recognized for the year ended December 31, 2024. Otherwise, research and development costs incurred during the years ended December 31, 2025 and 2024 primarily consisted of costs related to our babesiosis trial for tafenoquine. Direct trial-related costs represent 71% of the total research and development costs at $1,496,148 during the year ended December 31, 2025, compared to 27% of the costs at $1,359,532 during the year ended December 31, 2024. We also recorded $153,198 in research and development expenses related to commercial validation and packaging of Arakoda, for which a majority qualifies for reimbursement under the USAMMDA grant discussed above.
Previous wording
For the year ended December 31, 2024, our general and administrative expenses increased by 18.46% or $783,149 from the year ended December 31, 2023. During the year ended December 31, 2024, we recorded higher compensation expenses including $275,114 of bonus expense and $662,951 of salaries, taxes, and benefits expense, respectively (compared to $0 and $492,780 for the year ended December 31, 2023, respectively) due to certain sales and performance bonuses payable to our executives, and higher salaries due to hiring of our new Chief Commercial Officer in February 2024. Additionally, during the year ended December 31, 2024, we incurred $410,016 in legal and professional fees, $549,912 of insurance expenses, $1,019,111 of investor outreach expenses, and $433,884 of advertising and promotion expenses (up from $268,611, $304,581, $668,639, and $172,551 for the year ended December 31, 2023, respectively). These were partially offset by a significant decrease in stock-based compensation, which decreased from $528,926 for the year ended December 31, 2023 to $32,767 for the year ended December 31, 2024. The decrease is, in part, due to a decrease in the average grant date fair value of stock-based awards granted in 2024 as compared to 2023, as well as certain fully vested stock-based awards granted to our directors on the closing date of our IPO, and to our executives at the end of 2023.
Current wording
For the year ended December 31, 2025, our general and administrative expenses increased by 24.97% or $1,254,588 from the year ended December 31, 2024. During the year ended December 31, 2025, we recorded lower compensation expenses including $11,791 of bonus expense and $728,829 of salaries, taxes, and benefits expense, respectively (compared to $275,114 and $662,951 for the year ended December 31, 2024, respectively) due to certain sales and performance bonuses awarded to our executives in 2024. However, during the year ended December 31, 2025, we incurred $518,150 in legal and professional fees, $1,217,826 of investor outreach expenses, and $1,401,529 of sales advisory, advertising and promotion expenses (up from $410,016, $1,019,111, and $433,884 for the year ended December 31, 2024, respectively). Additionally, we recognized higher stock-based compensation costs, from $32,767 for the year ended December 31, 2024 to $279,873 for the year ended December 31, 2025. This increase was in part due to new partially vested option grants awarded to two executives in January 2025 and certain fully vested stock-based awards granted to our directors at the end of 2025, as well as the ongoing quarterly expense recognized for additional stock options granted in the third quarter of 2024.
Previous wording
For the year ended December 31, 2024, we recognized $7,912 of interest expense ($2,286,637 for the year ended December 31, 2023). 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 $8,772 and $179,117 for the years ended December 31, 2024 and December 31, 2023, respectively.
Current wording
For the year ended December 31, 2025, we recognized $7,805 of interest expense ($7,912 for the year ended December 31, 2024). Our interest expense for the periods presented relates primarily to our single outstanding loan from the SBA. Cash paid for interest was $8,772 and $8,772 for the years ended December 31, 2025 and December 31, 2024, respectively.
Previous wording
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. During the year ended December 31, 2024, derivative liabilities include the contingent milestone payment due to Knight upon a future sale of Arakoda or a Change of Control. The fair value of the contingent milestone payment is inversely related to the net present value of future investments in the Company and anticipated timing to profitability within our budget models. During the year ended December 31, 2023, derivative liabilities consisted of bridge shares, certain warrants, and embedded conversion features in our convertible notes, which were each converted or reclassified to equity upon the closing of our IPO. We use a probability-weighted expected return method or a Monte Carlo simulation model to estimate the fair value of these instruments.
Current wording
For the year ended December 31, 2025, we recognized a net gain on the change in fair value of derivative liabilities of $266,089 compared to a net gain of $1,665,966 for the year ended December 31, 2024. During the years ended December 31, 2025 and December 31, 2024, derivative liabilities include the contingent milestone payment due to Knight upon a future sale of Arakoda or a Change of Control. We use a probability-weighted expected return method to estimate the fair value of this derivative liability.
Previous wording
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. To date, we have financed our operations primarily through the issuance of common stock, warrants to purchase common stock, and proceeds from the issuance of convertible debt and promissory notes. 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. We cannot give assurance that we can increase our cash balances or limit our cash consumption and thus maintain sufficient cash balances for our planned operations or future acquisitions. Future business demands may lead to cash utilization at levels greater than recently experienced. We may need to raise additional capital in the future. However, we cannot assure you that we will be able to raise additional capital on acceptable terms, or at all.
Current wording
As of December 31, 2025, we had cash and cash equivalents of $1,510,065 ($1,659,353 as of December 31, 2024). For the year ended December 31, 2025 and 2024, our net cash used in operating activities was $6,849,022 and $5,648,088, respectively. To date, we have financed our operations primarily through the issuance of common stock, warrants to purchase common stock, and proceeds from the issuance of convertible debt and promissory notes. Based on current internal projections, taking into consideration the net proceeds of approximately $4.3 million received from the July 2025 public offering, and approximately $4.0 million in gross proceeds received through the 2025 ATM Agreement between October 15, 2026 and March 25, 2026, we estimate that we will have sufficient funds to remain viable through September 30, 2026, assuming no additional capital raises. We cannot give assurance that we can increase our cash balances or limit our cash consumption and thus maintain sufficient cash balances for our planned operations or future acquisitions. Future business demands may lead to cash utilization at levels greater than recently experienced. We may need to raise additional capital in the future. However, we cannot assure you that we will be able to raise additional capital on acceptable terms, or at all.
Previous wording
The following table summarizes our contractual obligations as of December 31, 2024:
Current wording
The following table summarizes our contractual obligations as of December 31,2025:
Previous wording
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. 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. In addition, we incurred $1,304,183 in costs related to our planned babesiosis trial for tafenoquine during the year ended December 31, 2024 ($0 during the year ended December 31, 2023).
Current wording
Net cash used in operating activities was $6,849,022 for the year ended December 31, 2025, as compared to $5,648,088 for the year ended December 31, 2024. Our net cash used in operating activities increased, in part due to higher general and administrative expenses of $6,279,823 for the year ended December 31, 2025 ($5,025,235 for the year ended December 31, 2024) primarily due to higher cash compensation and related expenses, legal and professional fees, investor outreach expenses, and advertising and promotion expenses, as discussed above. In addition, we incurred $1,496,148 in costs related to our babesiosis trial for tafenoquine during the year ended December 31, 2025 ($1,304,183 during the year ended December 31, 2024).
Previous wording
Cash Used in Investing Activities
Current wording
Cash Provided by (Used in) Investing Activities
Previous wording
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. 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, 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).
Current wording
Net cash provided by investing activities was $254,916 for the year ended December 31, 2025, as compared to cash used in investing activities of $1,889,114 for the year ended December 31, 2024. The decrease in cash used in investing activities is primarily driven by purchases of short-term certificates of deposit for a total cost of $1,235,000 during the year ended December 31, 2025 ($1,708,000 during the year ended December 31, 2024), purchased for the purposes of earning interest income. Additionally, purchases of computer and lab equipment totaled $139,881 during the year ended December 31, 2025 ($103,773 during the year ended December 31, 2024), and capitalized website development costs and patent costs totaled $22,670 and $55,533, respectively, for the year ended December 31, 2025 ($25,374 and $51,967 for the year ended December 31, 2024, respectively).
Previous wording
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 increase in net cash provided by financing activities is primarily attributable to (i) net proceeds of $1,914,513 received for the sale of common stock and warrants in January 2024, (ii) net proceeds of $1,790,670 from the sale of common stock pursuant to the At-the-Market Sales Agreement in July and August 2024, and (iii) $3,439,502 received from the sale of warrants in our Private Placement offering that closed in September 2024, in each case partially offset by payment of deferred offering costs. 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.
Current wording
Net cash provided by financing activities was $6,437,691 for the year ended December 31, 2025, as compared to $7,053,571 for the year ended December 31, 2024. The decrease in net cash provided by financing activities is primarily attributable to net proceeds aggregating to $7,042,608 received in connection with our common stock and warrant offering in January 2024, (ii) the sale of common stock pursuant to the At-the-Market Sales Agreement in July and August 2024, and (iii) the sale of warrants in our Private Placement offering that closed in September 2024, which exceeded the aggregate net proceeds of $6,452,887 received in connection with our common stock and warrant offerings completed in January, February, and July 2025 and the sale of common stock pursuant to the At-the-Market Sales Agreement in October and December 2025.
Previous wording
We record U.S. commercial revenues as a receivable when our American distributor transfers shipped product to their title model for 60P. Foreign sales to both Australia and Europe are recognized as a receivable at the point product is shipped to distributor. The shipments to Australia and Europe are further subject to profit sharing agreements for boxes sold to customers.
Current wording
We record U.S. commercial revenues as a receivable when our American distributor transfers shipped product to their title model for 60P. Foreign sales to both Australia and Europe are recognized as a receivable at the point product is shipped to distributor. The shipments to Australia and Europe were further subject to profit sharing agreements for boxes sold to customers.
Previous wording
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. A box price is calculated per lot number and sales are recognized by their lot number.
Current wording
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. A box or a bottle price is calculated per lot number and sales are recognized by their lot number.
Previous wording
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. ASU 2023-09 is effective for fiscal years beginning after December 15, 2024, with early adoption permitted. We are currently evaluating the impact that ASU 2023-09 will have on our financial statement disclosures.
Current wording
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. ASU 2023-09 was effective for us for our annual period ending December 31, 2025. The impact of the adoption is limited to our financial statement disclosures, which are presented on a prospective basis. See Note 9 to the accompanying consolidated financial statements.