iX Biopharma Ltd. has released a set of responses to shareholder questions in advance of its upcoming annual general meeting scheduled for Oct, 16 2026.
The company said Phase 3-enabling toxicology and pharmacokinetic studies for its sublingual ketamine wafer, Wafermine, are under way, funded by a US Department of Defense contract awarded in Feb, 2026. Over the next 12 months, iX Biopharma plans to hold a Type C meeting with the US Food and Drug Administration (FDA) and initiate two Phase 3 trials, KET006 and KET007. It also intends to file for an Emergency Use Authorization that, if granted, would permit supply of Wafermine to the US military before full FDA approval.
Separately, the group is preparing to launch a US compounding-pharmacy business using selected formulations from its portfolio of about 40 sublingual products. Freeze-dry equipment was relocated in Jun, 2026, with installation, commissioning, training and validation to follow.
As of Jun, 30 2026, the group held cash and cash equivalents of 14.74 million Singapore dollars, which management believes is sufficient for current requirements provided no major new initiatives are undertaken.
Regarding equity incentives, 36.36 million shares have been granted and remain outstanding or vested under the iX Performance Share Plan, representing about 22.2 % of the 15 % scheme limit. No options have been issued under the iX Employee Share Option Scheme.
Management added that decisions on monetizing Wafermine, including potential out-licensing, will be made after successful completion of Phase 3. Negotiations on a joint venture with Orion Specialty Labs are ongoing, with further announcements to follow upon material developments.