SXTP 最新10-Q变化

相对上期新增的文字 · 来源:10-Q · 2026-08-14

• On May 19, 2026, we received a letter from U.S. Food and Drug Administration (FDA) regarding Australian Chestnut Extract and their objection to us marketing it as a dietary supplement.

• On June 11, 2026, we announced the signing of a patent license with Florida State University (“FSU”) for the non-prescription use of Australian Chestnut extract as a botanical supplement.

• In addition, the Company has non-cancelable purchase obligations totaling $468,960, payable to its manufacturer Piramal, contingent upon the vendor meeting certain manufacturing milestones. $228,960 is expected to be payable around December 2026, with the remaining $240,000 is expected in March 2027…

• 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 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 the three months ended June 30, 2026, product revenues – net of discounts and rebates were $207,898, compared to $100,932 for the same period in 2025, an increase of $106,966, or 105.98%. The increase was attributable to two factors. First, the prior-year period was affected by a shortage of Ara…

相对上期删除的文字 · 来源:10-Q · 2026-05-15

• 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…

• 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 dis…

相对上期新增的文字 · 来源:10-Q · 2026-08-14

• As previously disclosed in our Annual Report on Form 10-K for the year ended December 31, 2025, management identified material weaknesses in our internal control over financial reporting relating to (1) inadequate design of policies and procedures, (2) lack of documentation, and (3) access control a…

• The remediation efforts set out in our Annual Report are largely dependent upon our securing additional financing to cover the costs of implementing the changes required. As of the date of this Quarterly Report, we have not yet completed the remediation of these material weaknesses. We continue to e…