60 Degrees Pharmaceuticals Announces Second Quarter 2025 Results

• A now resolved supply disruption led to Q2 net product revenue decline but higher profitability due to increased usage of a cash-pay distribution model
• $1.97 million cash on hand, runway through March 31, 2026
  
  

WASHINGTON, Aug. 13, 2025 (GLOBE NEWSWIRE) -- 60 Degrees Pharmaceuticals, Inc. (NASDAQ:SXTP, SXTPW)) (the "Company"), a pharmaceutical company focused on developing new medicines for infectious diseases, reported today its financial results for the second quarter of 2025, ended June 30, 2025.

While net product revenues declined compared to Q2 2024 due to a now resolved supply chain disruption, the Company reported an increase in profitability, largely attributed to cash-pay patients using KODATEF^® (tafenoquine) 16-count boxes which were imported with U.S. Food and Drug Administration (FDA) consent to help mitigate a temporary disruption of supply of ARAKODA^® 16-count boxes.

Provided the Company reaches minimum enrollment in its hospitalized babesiosis study prior to the end of the 2025 tick season in early October, the Company's current cash position is expected to allow the trial's interim analysis to be conducted prior to the need for additional capital.

Financial Highlights:

• Q2 2025 net product revenues decreased 19% year-over-year from $125 thousand to $101 thousand. This was associated with a decrease of 17% in ARAKODA pharmacy deliveries, from 1,301 boxes (Q2 2024) to 1,082 16-count box equivalents (Q2 2025). This occurred due to a temporary disruption of supply of ARAKODA 16-count boxes which was incompletely mitigated by the introduction of the new 8-count ARAKODA bottle, and importation, with FDA consent, of KODATEF (tafenoquine 16-count boxes). New commercial lots of ARAKODA 16-count boxes are anticipated to enter the supply chain in September, 2025.
• The Company achieved a gross profit of approximately $51 thousand in the second quarter of 2025, compared to an approximate gross profit of $35 thousand in the second quarter of 2024. This was primarily due to lower overall cost of sales and via the sale of KODATEF 16-count boxes (which had fewer discounts/rebates).
• Operating expenses were approximately $1.86 million in the second quarter of 2025, compared to approximately $4.22 million in the second quarter of 2024. This was primarily due to the absence of one-off, non-cash, research and development costs that occurred during the same period in 2024.
• Net loss attributable to common shareholders in the second quarter of 2025 was approximately $1.84 million, or ($1.25) per share, compared to a net loss of approximately $4.29 million, or ($21.12) per share in the second quarter of 2024, representing a $2.45 million decrease in loss.
  
  
• Based on current internal sales projections and considering the $1.97 million in cash/cash equivalents on hand at June 30, 2025, and the net proceeds of approximately $4.46 million received from our recent July 15 public offering, we expect to remain financially viable through March 31, 2026, assuming no additional capital is raised. If we are successful in enrolling a total of at least 24 patients in our hospitalized babesiosis patient study before the end of the tick season in early October 2025, we expect the trial's interim data analysis to be conducted prior to March 31, 2026.

Business Highlights for the Quarter Ended June 30, 2025

• The Company concluded several commercial research studies that collectively suggest that annual incidence of babesiosis is between 25,000 and 380,000 cases and that the total addressable U.S. market for ARAKODA for human babesiosis may approach $1.1 billion over the remaining 10-year patent life.
• A new 8-count bottle format of ARAKODA was introduced into the U.S. supply chain. This option will reduce the cost of ARAKODA for short-term travelers to malaria-endemic regions of the world.

About 60 Degrees Pharmaceuticals, Inc.

60 Degrees Pharmaceuticals, Inc., founded in 2010, specializes in developing and marketing new medicines for the treatment and prevention of infectious diseases that affect the lives of millions of people. 60 Degrees Pharmaceuticals, Inc. achieved FDA approval of its lead product, ARAKODA^® (tafenoquine), for malaria prevention, in 2018. 60 Degrees Pharmaceuticals, Inc. also collaborates with prominent research organizations in the U.S., Australia, and Singapore. The 60 Degrees Pharmaceuticals, Inc. mission has been supported through in-kind funding from the U.S. Department of Defense and private institutional investors including Knight Therapeutics Inc., a Canadian-based pan-American specialty pharmaceutical company. 60 Degrees Pharmaceuticals, Inc. is headquartered in Washington D.C., with a majority-owned subsidiary in Australia. Learn more at www.60degreespharma.com.

Cautionary Note Regarding Forward-Looking Statements

This press release may contain "forward-looking statements" within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. Forward‐looking statements reflect the current view about future events. When used in this press release, the words "anticipate," "believe," "estimate," "expect," "future," "intend," "plan," or the negative of these terms and similar expressions, as they relate to us or our management, identify forward‐looking statements. Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based only on our current beliefs, expectations and assumptions regarding the future of our business, future plans and strategies, projections, anticipated events and trends, the economy, activities of regulators and future regulations and other future conditions. Because forward-looking statements relate to the future, they are subject to inherent uncertainties, risks and changes in circumstances that are difficult to predict and many of which are outside of our control. Our actual results and financial condition may differ materially from those indicated in the forward-looking statements. Therefore, you should not rely on any of these forward-looking statements. Important factors that could cause our actual results and financial condition to differ materially from those indicated in the forward-looking statements include, among others, the following: there is substantial doubt as to our ability to continue on a going-concern basis; we might not be eligible for Australian government research and development tax rebates; if we are not able to successfully develop, obtain FDA approval for, and provide for the commercialization of non-malaria prevention indications for tafenoquine (ARAKODA^® or other regimen) or Celgosivir in a timely manner, we may not be able to expand our business operations; we may not be able to successfully conduct planned clinical trials; and we have no manufacturing capacity which puts us at risk of lengthy and costly delays of bringing our products to market. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company's filings with the Securities and Exchange Commission ("SEC"), including the information contained in our Annual Report on Form 10-K filed with the SEC on March 27, 2025, and our subsequent SEC filings. Investors and security holders are urged to read these documents free of charge on the SEC's web site at www.sec.gov. As a result of these matters, changes in facts, assumptions not being realized or other circumstances, the Company's actual results may differ materially from the expected results discussed in the forward-looking statements contained in this press release. Any forward-looking statement made by us in this press release is based only on information currently available to us and speaks only as of the date on which it is made. We undertake no obligation to publicly update any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise.

Media Contact:

Sheila A. Burke

[email protected]

(484) 667-6330

Investor Contact:

Patrick Gaynes

[email protected]

(310) 989-5666