iX Biopharma: Wafermine plans ‘not dependent’ on Nevada partner Orion, which lacks state license

[SINGAPORE] Catalist-listed drugmaker iX Biopharma said its plans to manufacture Wafermine for the US military are not dependent on its proposed joint-venture partner Orion Specialty Labs, which has yet to secure a required operating licence in Nevada.

Orion’s difficulty in securing an outsourcing facility licence in Nevada was first reported by US news publication Politico on Oct 20, raising questions over its ability to manufacture drugs for iX Biopharma’s US operations.

The specialty pharmaceutical company said in response to queries by The Business Times that its US$41 million contract with the US Department of Defense (DoD) is separate from its planned joint venture with Orion.

“To be clear, the DoD contract does not depend on Orion,” said Eva Tan, chief commercial officer of iX Biopharma.

The company secured a contract in February 2026 to fund the development of Wafermine, a ketamine wafer taken sublingually, that is, under the tongue, for the treatment of pain in military casualties.

In September, the US government opened an emergency regulatory pathway that could allow Wafermine to be deployed ahead of it obtaining full approval by the Food and Drug Administration (FDA).

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The company still has to secure a separate Emergency Use Authorisation (EUA) for the drug from the FDA.

In November 2025, iX Biopharma announced a non-binding term sheet with Orion to set up a US manufacturing base for its longevity-focused, sublingual consumer products.

Orion is registered with the FDA as a Section 503B outsourcing facility, a designation allowing compounded or custom-made drugs to be manufactured in bulk for hospitals and healthcare providers, rather than individual patients.

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However, FDA registration does not constitute facility approval, and Orion has yet to obtain the necessary operating licence from Nevada’s pharmacy board.

Orion’s licensing woes

Orion’s representatives appeared before the Nevada pharmacy board in March and June this year to seek approval for its application for the outsourcing facility licence.

Both times, the application was tabled amid concerns raised by board members, including questions over the qualifications of its pharmacist in charge and its ownership structure.

In its November 2025 announcement, iX Biopharma described Orion as operating a pharmaceutical facility that is currently compliant with good manufacturing practices, in that it has “operationally ready infrastructure and regulatory licences”.

When queried by BT, Tan clarified that the reference to regulatory licences meant Orion’s FDA registration as a 503B outsourcing facility.

Tan confirmed that Orion does not currently hold a Nevada outsourcing facility licence, though she maintained that the manufacturing of Wafermine for the company’s contract with the DoD is not tied to Orion’s facility.

The company had previously stated in its fourth-quarter financial results that equipment relocated from its Australian manufacturing facility to Orion’s Nevada site would enable it to fulfil Wafermine orders under the DoD contract.

“We are evaluating a number of manufacturing pathways, of which Orion’s site is one option,” she said.

Tan said that Orion’s site offered iX Biopharma the infrastructure it needed to manufacture its products under its US consumer business, which was arranged prior to the DoD contract in February 2026.

“The key point was that partnering with Orion meant we did not need to build our own US facility from the ground up, which would have taken significant time and capital,” she said.

Tan said iX Biopharma expects the Nevada licensing to follow the finalisation of the joint venture and installation of its manufacturing equipment.

The joint venture agreement remains at an “advanced stage of negotiation” on its final terms, said Tan.

iX Biopharma has attracted renewed investor attention following the developments in Wafermine’s regulatory pathway and the company’s DoD contract.

In October, KGI Securities initiated coverage on the ticker with an “outperform” rating and a S$1.17 target price, and OCBC initiated coverage with a “buy” rating and a S$0.92 fair-value estimate.

Both brokerages cited the DoD contract as reducing financing risks associated with Wafermine’s Phase 3 clinical trials.

When reached by BT about iX Biopharma’s disclosure obligations on the subject, a Singapore Exchange Regulation (SGX RegCo) spokesperson said it does not publicly comment on regulatory interactions with individual issuers.

RegCo added that its listing rules require companies to announce material information to investors.

“Beyond that, companies should also keep investors updated on significant developments in their forward plans,” said the spokesperson.