Microbix: RNA Controls, Kinlytic Progress, and the Shift to Direct Customers
A Steady Quarter of Recovery
Microbix's fiscal Q3 (June 30, 2026) results signal a genuine turnaround from the client-specific setbacks of mid-2025. CEO Cameron Groome opened the call by emphasizing the resumption of growth: ““In the Q3, we demonstrated, I think, solid year over year growth of 17% for the quarter close to our goal of, at least 20% year over year sales growth and really putting us back on track following the 2 client-specific setbacks.” — Cameron L. Groome, CEO · 2026-08-13 Antigen sales rose 20% and controls (caps) rose 13%, while gross margins improved to 4% (from 41% a year earlier, though later discussion implies the improvement is more meaningful). The company continues to keep operating expenses under control, posting a modest net loss while maintaining a cash position of $7.2 million.
The recovery is also being driven by a deliberate diversification of revenue. CFO James Currie noted that business-to-consumer (B2C) sales—recurring orders from end-user clinical laboratories—grew 35% sequentially, and now exceed a seven-figure annual run rate. This is a notable shift from the historical heavy reliance on a few large diagnostics customers, reducing customer concentration risk. As Cameron put it: ““We are seeing a growing proportion of b to c sales These are sales to end user clinical laboratories. And that is a more diverse client base and very much a recurring stream of sales that is not the dependent on any single client.” — Cameron L. Groome, CEO · 2026-08-13
Kinlytic: On Track for a 2027 Refiling
The therapeutic asset program, drug substance production for Kinlytic, continues to advance with partner Sequel. COO Kenneth Hughes detailed major breakthroughs in process development that have increased yields and therefore will improve margins. The team is preparing engineering batches and developing comparability protocols to present to the FDA.
“I will start by saying that we do not make oligos for controls, and whether it is an RNA oligo or a DNA oligo, so I will not give any particular technical details unless Cameron wants to, but suffice it to say that RNA is armored. So it is encapsulated, it looks like the product that you are supposed to be testing for, as do all our CAPS.
That statement, about armored RNA controls, actually ties to a broader strategic expansion into synthetic controls for RNA-based viruses—a capability presented at the ESCMID conference. This is a new area for Microbix, and it deepens their offering for new assay development, particularly for molecular diagnostics. The comparability protocols for Kinlytic are being developed to show the new production process yields a product equivalent to the incumbent. Management expects to meet with the FDA before the end of 2026 and refile the sBLA in 2027—a timeline consistent with prior guidance. As Ken Hughes affirmed in a prior call, “the timeline remains the same for 2027.” — Ken Hughes, Chief Operating Officer · 2025-05-15
The Kinlytic program is fully funded by Sequel, with no dilution risk to shareholders, and the relationship remains “extremely strong” according to the COO. The drug product CDMO is also progressing, and senior hires are being made across the program, signaling confidence in the expected 2027 submission.
New Capabilities and a Shift Toward Direct Customers
Beyond Kinlytic, Microbix is building momentum in its core diagnostics business. The introduction of synthetic controls for RNA viruses is a meaningful expansion of their test cartridge portfolio, allowing them to serve test manufacturers with more sophisticated validation tools. The company is actively engaging multiple major international diagnostics companies for CAPS-related projects, with one advancing toward a formal agreement that could be disclosed later this year.
Meanwhile, China—a historically significant market—is showing early signs of recovery. After falling to near-zero, sales have moved back into the six-figure range this year, and management expects to reach seven figures in fiscal 2027, potentially normalizing to $2–3 million per year. This represents a cautious but optimistic rebound from the drastic slowdown. In a prior call, Cameron had noted the market's opacity: “China is not the most transparent market. We've certainly been pushing hard at our distributor to get a good handle on that. We've not seen sales in China resume too much of an extent as yet.” — Cameron Groome, Chief Executive Officer (CEO) · 2026-02-12
The company is also leveraging its new assay opportunities through the QUANTDx reference materials line, which supports test developers in early-stage validation and provides ongoing revenue streams as products move to commercial release. Management emphasized that the business is now growing into profitability, with a focus on operational efficiencies and yield improvements. As CFO James Currie stated on the call, “We continue to be bullish,” and the outlook for Q4 is for continued sequential growth.
Summary
Microbix's Q3 results demonstrate that the recovery from the 2025 setbacks is firmly underway. The company has reaccelerated revenue growth, expanded gross margins, and is making tangible progress on both its diagnostics franchise and the Kinlytic therapeutic asset. The introduction of armored RNA controls and the growing B2C channel represent new strategic levers that should reduce volatility and broaden the customer base. With a clean balance sheet and a clear path to breakeven, Microbix appears well-positioned to deliver on its promises as it heads into fiscal 2027.