Quratis

Quratis is a vaccine-focused biotech that runs the full development chain in-house, from candidate discovery through process development, clinical trials, approval, and commercial manufacturing, with the tuberculosis vaccine candidate QTP101 as its lead pipeline asset.

QTP101 combines a recombinant fusion protein antigen derived from Mycobacterium tuberculosis with the company's proprietary GLA-SE adjuvant, and is currently in a multinational Phase 2b/3 trial spanning Korea and the Philippines.

The pipeline also includes QTP105, a vaccine candidate for the tropical parasitic disease schistosomiasis currently in Phase 1b, and QTP104, a next-generation mRNA COVID-19 vaccine candidate.

The company's other business line is contract development and manufacturing (CDMO) based on its Osong Bioplant in Chungbuk, which houses both drug substance and drug product (liquid and lyophilized) lines with capacity for up to 50 million liquid injectable vials per year.

Its CDMO customer base skews toward biotech ventures and small-to-mid-sized pharmaceutical companies rather than large pharma, reflecting a niche strategy focused on high-mix, low-volume production.

Since Inventage Lab, a long-acting injectable platform company, became the controlling shareholder in February 2025, the Osong Bioplant has also served as a manufacturing partner for Inventage Lab's own pipeline in obesity, dementia, and addiction treatment, both for clinical and commercial supply.

The two companies signed a KRW 7 billion supply contract to build a dedicated microfluidics-based long-acting injectable CDMO production line.

The Osong Bioplant holds KGMP certification domestically as well as US cGMP and EU-GMP-level qualifications, giving it the manufacturing base needed to supply clinical trial materials globally.

Annual revenue fell sharply from KRW 8.4 billion in 2022 to KRW 1.0 billion in 2023 and KRW 0.4 billion in 2024, before rebounding to KRW 2.5 billion in 2025, a recovery largely attributable to CDMO service revenue becoming the dominant sales component.

The operating loss narrowed from KRW 22.4 billion in 2022 to KRW 16.9 billion in 2023, widened again to KRW 19.7 billion in 2024, then narrowed to KRW 10.3 billion in 2025.

Net losses shrank from KRW 36.3 billion in 2022 to KRW 17.0 billion in 2023 but then widened to KRW 26.3 billion in 2024 and KRW 29.7 billion in 2025.

On a quarterly basis, Q2 2025 posted revenue of KRW 0.48 billion, an operating loss of KRW 3.3 billion, and a net loss of KRW 10.1 billion, while Q3 showed revenue of KRW 0.51 billion with the operating loss narrowing to KRW 2.2 billion.

Q4 revenue fell to KRW 0.26 billion and the operating loss stayed roughly flat at KRW 2.2 billion, but the net loss expanded sharply to KRW 12.3 billion, suggesting non-operating items may have added to the bottom-line loss that quarter.

In Q1 2026, revenue collapsed to about KRW 9.5 million; a Wiseinfo report noted that non-consolidated Q1 revenue fell 99.3% year over year.

Still, the operating loss of KRW 2.5 billion did not widen materially versus the prior quarter, and in Q2 2026, revenue recovered to KRW 0.32 billion with an operating loss of KRW 3.0 billion and a net loss of KRW 3.0 billion, a comparatively smaller net loss relative to preceding quarters.

Total equity swung from a negative KRW 26.0 billion (capital impairment) in 2022 to KRW 36.1 billion in 2023, KRW 20.5 billion in 2024, and KRW 44.3 billion in 2025, reflecting multiple rounds of capital raises and convertible bond issuance and conversion.

A June 2026 Daishin Securities company report noted that CDMO service revenue accounted for most of 2025 sales and that the operating loss narrowed on lower selling and administrative expenses, adding that cash and equivalents stood at KRW 14.4 billion and total equity at KRW 50.3 billion at the end of Q1, both up from year-end 2025.

Tuberculosis is regarded as one of the world's three major infectious disease threats alongside malaria and HIV/AIDS, and the World Health Organization has estimated the investment value of adolescent and adult tuberculosis vaccines at approximately $372 billion.

Because the protective effect of the BCG vaccine given in infancy fades within roughly a decade, a separate booster vaccine is needed for adults, yet only a handful of developers worldwide have advanced candidates into late-stage trials for this market.

At the WHO-hosted tuberculosis vaccine industry roundtable in July 2026, Quratis presented its QTP101 supply and manufacturing strategy alongside Gates MRI/GSK, BioFabri/Bharat Biotech, and BioNTech, underscoring its recognition as one of four global candidate developers.

Industry observers note that development of tuberculosis vaccines by GSK (UK) and SSI (Denmark) is widely presumed to have effectively stalled given years without official progress updates, a backdrop against which Quratis is seen as relatively advanced in late-stage trial progression.

On the CDMO side, large domestic players such as Samsung Biologics, SK Bioscience, and Lotte Biologics continue to expand capacity as the broader market grows, and Quratis has chosen to target a niche of high-mix, low-volume production for biotech ventures and small-to-mid-sized pharma companies rather than compete on scale economics.

Its collaboration with controlling shareholder Inventage Lab also positions it as a specialized manufacturing partner in the long-acting injectable segment.

Quratis has stated that it is pursuing global development of QTP101 through parallel, multi-region programs spanning the United States, Europe, and Africa.

In the United States, preparation is underway for a tuberculosis therapeutic vaccine clinical program (A5397/HVTN 603) run by an NIH-affiliated clinical research network, with a site inspection of the Osong Bioplant that the company said was scheduled for early August 2026.

In Africa, a Phase 2a trial of a single-vial formulation is being advanced in South Africa and Nigeria with EDCTP3 support. Domestically, a trial in elderly subjects is progressing, with the company targeting Phase 2 entry as early as the first quarter of 2027.

On the CDMO side, the Osong Bioplant passed an EU-GMP QP on-site inspection in late January 2026, following US FDA cGMP-level approval for clinical trial material supply in July 2025, giving it a manufacturing base capable of supplying clinical materials for European and US trials.

With Inventage Lab's contract manufacturing facility construction completed and commissioning finished, the two companies are negotiating supply pricing for clinical trial materials for pipeline candidates including IVL3003 (dementia), IVL3021 (obesity), and IVL3024 (diabetes), with full-scale production announced as forthcoming.

On the financial side, the company is pursuing balance sheet repair and compliance with KOSDAQ listing maintenance requirements simultaneously through the 9-for-1 capital reduction, which cut registered capital and offset part of the accumulated deficit.