SXTP — what changed in the latest 10-Q

Text added vs the prior filing · source: 10-Q · 2026-05-15

• On January 22, 2026, we announced our partnership with Runway Health, a direct-to-patient telehealth platform, to expand pre-departure access to Arakoda for prevention of malaria among international travelers through the Runway Health travel medicine platform. The partnership with Runway Health comm…

• On January 26, 2026, we exercised an option under our agreement with Florida State University (“FSU”), at no cost, to negotiate an exclusive license to use large-scale purification techniques to extract castanospermine from the seeds of Castanospermum australe (commonly known as the Australian Chest…

• On February 2, 2026, we commenced our partnership with GoodRx, the leading platform for prescription savings in the U.S., to offer eligible patients savings of up to 30% on Arakoda.

• On March 11, 2026, we announced that all three enrolled patients were cured of babesiosis after completing the tafenoquine regimen in the Company’s trial of relapsing babesiosis in immunosuppressed patients.

• On March 11, 2026, we submitted a New Dietary Ingredient Notification (NDIN) to the U.S. Food and Drug Administration (FDA) for Australian Chestnut Extract. The FDA has until May 25, 2026, to object to the notification, after which the Company will be free to market our planned dietary supplement co…

Text removed vs the prior filing · source: 10-Q · 2025-11-13

• On July 14, 2025, we announced our intent to seek a Minor Use Minor Species (MUMS) designation from the United States Food and Drug Administration (FDA) for the treatment of acute canine babesiosis upon completing a gap analysis of our existing data.

• After completing a 6,000 nationwide patient survey and quantitative research study, on July 15, 2025, we announced that we had determined the total addressable market (TAM) for Babesiosis treatment to be $1.1 billion through patent expiration in 2035.

• On July 17, 2025, we announced our entry into a sponsored research agreement with Tulane University to evaluate activity of tafenoquine against lyme and bartonella bacteria.

• On August 19, 2025, we announced our partnership with the Icahn School of Medicine at Mount Sinai for our planned Phase II clinical study of tafenoquine in treating chronic babesiosis.

• On July 15, 2025, we entered into a securities purchase agreement with certain institutional investors pursuant to which we sold, in a registered direct offering (the “July 2025 Offering”), 1,753,314 units at an offering price of $1.90 per unit and 878,264 pre-funded units at an offering price of $1…

Text added vs the prior filing · source: 10-Q · 2026-05-15

• Based on this assessment, our management concluded that our internal control over financial reporting was not effective as of March 31, 2026, due to the existence of material weaknesses in our internal control over financial reporting. These material weaknesses are described below:

• Inadequate Design of Policies and Procedures: We did not design policies and procedures at a sufficient level of precision to support the operating effectiveness of controls to prevent and detect potential errors.

• Lack of Documentation: There was a failure to maintain adequate documentation to evidence the operating effectiveness of certain control activities and a lack of proper levels of supervision and review of complex accounting matters.

• Access Control and Segregation of Duties: Inadequate controls in place related to maintaining appropriate access to certain systems and maintaining appropriate segregation of duties within those systems.

Text removed vs the prior filing · source: 10-Q · 2025-11-13

• Our management concluded that as of September 30, 2025, our internal control over financial reporting was not effective, and that material weaknesses existed in the following areas:

• we do not employ full time in-house personnel with the technical knowledge to identify and address some of the reporting issues surrounding certain complex or non-routine transactions. With respect to material, complex and non-routine transactions, management has and will continue to seek guidance f…

• we have inadequate segregation of duties consistent with the control objectives including but not limited to the disbursement process, transaction or account changes, and the performance of account reconciliations and approval; and

• we have ineffective controls over the period end financial disclosure and reporting process caused by insufficient accounting staff.