ViroGates announces its interim report for Q1-Q3 2026

BIRKERØD, DENMARK - ViroGates A/S (“ViroGates” or the “Company”), a medical technology company developing blood tests for measuring chronic inflammation at health clinics and hospitals, announces its interim report for the period 1 January to 30 September 2026, as approved today by the Company's Board of Directors. The report is unaudited.

In Q1-Q3 2026, ViroGates reported revenue of DKK 6.2 million, an increase of 75% compared to Q1-Q3 2025 (DKK 3.5 million). As explained in the half-year report, growth was concentrated in the second quarter, when the Company's U.S. commercial partner, suPARbio™, took delivery of its minimum order under the 2024 distribution agreement. With that stock in place, Q3 revenue was slower, as expected, ending at DKK 1.1 million (Q3 2025: DKK 1.7 million). The next step is the roll-out of suPARnostic® through higher-volume commercial channels, which is key to broader adoption and scalable testing volumes. Operating loss (EBIT) improved to DKK -6.6 million (Q1-Q3 2025: DKK -7.9 million), and cash and cash equivalents amounted to DKK 14.9 million at the end of September.
 
In the U.S., suPARbio™ has moved further into the roll-out of suPARnostic® to end users, and ViroGates continues to provide technical assistance, product guidance, and laboratory implementation support as testing activity builds. suPARbio™ is approaching several potential channel partners in the longevity, prevention, and population-wide health screening markets.
 
Other major activities and developments included the submission of a De Novo application for suPARnostic® TurbiLatex with Swedish Orphan Biovitrum (Sobi) in April 2026 for use in combination with Kineret® (anakinra) (cf. Company Announcement No. 3-2026). As anticipated, the U.S. Food and Drug Administration (FDA) has requested additional information, and ViroGates held a Q-Sub meeting with the FDA on 3 September 2026 to clarify the need for additional study data. ViroGates and Sobi are preparing clinical and analytical data for the response. This work is not expected to have a revenue impact in 2026.
 
On the EU regulatory side, ViroGates advanced the transition of the suPARnostic® product line to the IVDR framework, upgrading its ISO systems and technical documentation ahead of an audit by the Notified Body.
 
Within research and development, ViroGates and GENSPEED Biotech completed further testing and refining of the suPARnostic® POC+ device during the reporting period. ViroGates is awaiting additional clinical data to assess the viability of a regulatory validation program and an approval submission. Currently, the product still needs strengthening of the clinical documentation before the validation can be conducted. ViroGates expects that a formal decision on progression into the IVDR conformity validation phase can be made during Q1 2027. A validation program and approval will take approximately one year.
 
ViroGates reports 18 recurring customers by the end of Q3 2026 (defined as customers placing at least two orders with an accumulated value above 10,000 EUR in the past 12 months), unchanged from the end of Q3 2025. Because the partnership-led strategy targets fewer, larger relationships, the Annual Report 2026 will be the last report with recurring customers as a KPI. From 2027, ViroGates will report revenue by product and geographic area and update on progress with key partners, including roll-out and testing volumes as they materialize.
 
On 3 August 2026, ViroGates announced a shift from a traditional sales-driven model toward a business development model focused on larger and more scalable partnerships (cf. Company Announcement No. 6-2026). Alexandre Delatour joined as VP of Business Development in August, and Thomas Krarup, VP Global Sales & Marketing, left the Company on 30 September 2026. ViroGates is now reviewing its partner portfolio to assess where current distributors and partners can take greater ownership of their local markets.
 
The strategic refocusing continues to involve execution risk related to regulatory processes, commercialization timelines, and organizational transition. ViroGates maintains its full-year guidance for 2026, revised in August (cf. Company Announcement No. 7-2026), and expects revenue of DKK 6.5 to 8 million and EBIT of DKK -10 to -12 million.
 
Jakob Knudsen, CEO of ViroGates, says: "With our new commercial organization now in place, ViroGates has moved from restructuring to execution. We are reviewing our partner portfolio to see where current partners can take greater ownership of their local markets and where new partners can help us reach more end users. In parallel, we are preparing our response to the FDA based on valuable guidance from our Q-Sub meeting in September, and upgrading our systems and documentation ahead of the IVDR audit. Our ambition is fewer, larger relationships that can scale faster, and we look forward to updating the market as new partnerships materialize."
 
Financial results in Q1-Q3 2026

• Revenue increased by 75% to TDKK 6,212 (TDKK 3,542)
• Operating expenses amounted to TDKK -11,645 (TDKK -12,578)
• Operating loss (EBIT) decreased by 16% to TDKK -6,643 (TDKK -7,904)
• Net loss decreased by 29% to TDKK -5,679 (TDKK -7,961)
• Cash and cash equivalents at the end of the period amounted to TDKK 14,885 (TDKK 9,120) 

Business highlights in Q1-Q3 2026

• ViroGates and Sobi submitted the De Novo application to the U.S. FDA for suPARnostic® TurbiLatex in April 2026, for use in combination with Kineret® (anakinra) (cf. Company Announcement No. 3-2026). As anticipated, the FDA has requested additional information, and following a Q-Sub meeting on 3 September 2026, the parties are preparing clinical and analytical data for the response.
• ViroGates and GENSPEED Biotech moved suPARnostic® POC+ from proof of concept into testing and validation. The parties are awaiting additional clinical data to assess the viability of a regulatory submission.
• ViroGates' U.S. partner, suPARbio™, took delivery of the minimum order under the 2024 distribution agreement, building up stock ahead of a scalable commercial launch. ViroGates continues to support and closely follow the roll-out.
• On 3 August 2026, ViroGates announced a shift toward a business development model built on larger, more scalable partnerships. Alexandre Delatour joined as VP of Business Development, and Thomas Krarup, VP Global Sales & Marketing, left ViroGates at the end of September (cf. Company Announcement No. 6-2026).
• ViroGates revised its 2026 guidance to revenue of DKK 6.5 to 8 million, with EBIT maintained at DKK -10 to -12 million (cf. Company Announcement No. 7-2026). The guidance is maintained in this report.
• Reported a recurring customer base of 18 customers (18 at the end of Q3 2025).

This announcement is a summary and should be read with ViroGates' Interim Report Q1-Q3 2026, published on 5 November 2026. A downloadable PDF version is available on ViroGates’ website.
 
For further information, please contact:
ViroGates A/S:
CEO, Jakob Knudsen
Tel. (+45) 2226 1355, email: jk@virogates.com

Certified Advisor:
Västra Hamnen Corporate Finance AB
Per Lönn
Tel. (+46) 40 200 250 | Email: per.lonn@vhcorp.se
 

About ViroGates

ViroGates A/S is an international medical technology company that develops and markets blood tests to measure chronic inflammation at health clinics and improve hospital patient care. ViroGates markets its blood test products under the suPARnostic® brand.
 
The company was founded in 2000. Headquartered in Denmark, ViroGates sells directly to markets across the EU and the rest of the world, complemented by a network of distributors covering selected markets. ViroGates’ shares (ticker “VIRO”) are listed on Nasdaq First North Growth Market Denmark. For more information, please visit www.virogates.com.