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Excerpts from KGI Securities report
Analyst: Chen Guangzhi
▪ Wafermine® Emergency Use Authorization (EUA) pathway at final regulatory step.
A US emergency declaration published on 3 September 2026 allows FDA to consider drugs for moderate-to-severe acute pain in military casualties. |
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▪ Phase 3 derisked with Department of War (DoW) funding. In February 2026, iX received a sole-source US$40.95mn DoW award to fund Wafermine's EUA work and Phase 3 programme.
Sole-source awards are made when the US Government determines that only one supplier can meet its requirement.
The funding lets iX keep full ownership of Wafermine through Phase 3 and approach partners with late-stage data, which should command better licensing terms.
▪ Policy support for non-opioid pain treatment. According to the CDC, opioids were involved in c.64% of the 69,973 US drug-overdose deaths in 2025 and FDA has issued guidance to encourage non-opioid pain medicines.
DelveInsight expects the seven-major-market acute-pain market to grow from US$4.5bn in 2025 to US$15.5bn by 2036.
▪ Compounding pharmacy offers immediate monetisation. Through Ligo, iX has a portfolio of about 40 sublingual wafer products, which management says are ready for compounding without further clinical work, to US compounding pharmacies.
These span men's and women's health, weight management and longevity.
The company estimates the US compounding market at US$10.7bn by 2033.
Management expects B2B sales to begin in 1Q CY2027, and we forecast c.S$20mn of compounding revenue in FY28F.
| Human validation is strongest for Wafermine |
The Company has tested absorption and pharmacokinetics (PK) in humans across numerous active drug compounds, including buprenorphine, ketamine and dexmedetomidine.
Wafermine® has completed seven clinical studies involving 320 participants, including a Phase 2b study on safety and efficacy.
|
Stock price |
$0.53 |
|
52-week range |
$0.08-$0.63 |
|
Market cap |
$580 M |
|
52-week change |
502% |
|
PE (ttm) |
-- |
|
Dividend yield (ttm) |
-- |
|
P/B |
37 |
One of these, a published Phase 1 study in eight healthy male participants reported absolute bioavailability of approximately 29% for a 25mg sublingual ketamine wafer.
Ketamine was first quantifiable in plasma within five minutes, while median time to maximum concentration was approximately 0.75 hours. The formulation was reported to have good local tolerability.
This study shows that the wafer can deliver ketamine rapidly. While clinical data are most advanced for Wafermine® and other formulations remain at earlier stages, this human evidence reduces platform risk relative to a technology supported only by laboratory testing.
We initiate coverage on iX Biopharma with an OUTPERFORM rating and a 12- month target price of S$1.17, based on SOTP, implying 120.8% upside from the S$0.53 last close. Risks. |
 See earlier story: iX BIOPHARMA: Why Investors Are Paying S$600M for Future Value |
