SINGAPORE – Catalist-listed iX Biopharma’s US expansion plans have come under scrutiny after questions emerged over the licensing status of its prospective US manufacturing partner, Orion Specialty Labs.
The Singapore drugmaker, whose share price has more than tripled since the start of 2026, has also been in the spotlight recently over a US$41 million US Department of Defense contract for its “ketamine wafer” Wafermine for use on the battlefield, awarded in February.
In November 2025, iX Biopharma announced plans to form a US joint venture with Orion to manufacture and sell its proprietary sublingual wafer products – medicines absorbed under the tongue.
In a Nov 3, 2026, filing in response to Singapore Exchange (SGX) queries, iX Biopharma clarified that Orion has yet to obtain a Nevada state licence and their joint venture agreement remains unsigned.
It added that its joint venture negotiations with Orion were at an advanced stage, with final terms, due diligence and tax assessments being worked through.
SGX’s questions followed an Oct 20 investigative report that Orion had yet to secure the state licence required to operate its facility and that its application had been postponed twice.
The exchange asked how this squared with iX Biopharma’s November 2025 announcement that its partnership with Orion would allow it to immediately tap Orion’s “operationally ready infrastructure and regulatory licences” to accelerate the US commercialisation of its products.
The drugmaker said the licensing timeline with Orion is consistent with its plans, and maintained that its earlier announcements remained accurate when read in full context.
iX Biopharma replied that in referring to “regulatory licenses”, it had meant Orion’s registration with the US Food and Drug Administration (FDA) as a 503B outsourcing facility in its announcement.
Such facilities prepare qualifying compounded medicines for healthcare providers under a separate regulatory framework. Compounding involves preparing medicines in formulations suited to particular patient needs.
The Nevada state licence is a separate requirement that was always expected to follow the finalisation of the joint venture and installation of its equipment, it said.
iX Biopharma said any earlier licence applications were made by Orion independently and that it is unable to comment on those applications.
It also explained that “operationally ready infrastructure” referred to Orion’s site having the infrastructure to accommodate its manufacturing operations, and that partnering Orion would save it the time and expense of building a US facility from scratch.
The company’s proprietary WaferiX technology requires a specific facility set-up.
iX Biopharma said it began moving specialised freeze-drying equipment from Australia to Orion’s facility in June. The equipment remains owned by iX Biopharma and could be moved to another manufacturing site if needed.
It added that its US military contract to develop a ketamine-based pain drug is separate from the joint venture and does not depend on Orion’s facility.
In an Oct 10 response to shareholders ahead of its annual general meeting, iX Biopharma said it was preparing to launch that business with selected products from its portfolio of around 40 sublingual formulations.
In a Sept 7 statement, iX Biopharma said a US government emergency declaration published on Sept 3 had opened a regulatory pathway for Wafermine to be considered for emergency use in military casualties.
Wafermine is described as having a rapid, “strong analgesic effect” for the treatment of acute moderate to severe pain.
If authorised, it could be supplied to US military personnel and generate revenue before full FDA approval, even while clinical trials for broader use, including by civilian patients, continue. The military contract will cover both the emergency use authorisation work and the clinical trial programme.
In September, the company said it expected to complete its emergency use submission in the fourth quarter of 2026. In its Oct 10 shareholder responses, it said it expects to complete the filing within the next 12 months.
The drugmaker’s shares rose after it replied to SGX, closing Nov 4 at 48 cents, up more than 1%.
In an Oct 12 report initialing coverage on the stock, KGI Securities analyst Chen Guangzhi noted that the stock could more than double from its current level to $1.17 in the next 12 months.
But this is assuming Wafermine secures FDA authorisation for emergency military use and full approval for broader civilian use, and attracts a pharmaceutical partner to license its civilian commercialisation rights.
Chen forecasts that the loss-making company could turn a profit of $138.9 million by 2029, driven largely by an assumed upfront payment from licensing Wafermine for civilian use.
The analyst also flagged risks including unsuccessful or delayed trials, a delayed or rejected emergency use application, weaker licensing terms and a slower rollout of the compounding business.
He warned that the company might also require additional funding over the next two years, given that the US government contract reimburses costs only after they are incurred, which could leave gaps between spending and payment.
