ENVALITH
カルナバイオサイエンス株式会社 logo

Carna Biosciences, Inc.

4572・Growth Market・Pharmaceuticals

Official website
カルナバイオサイエンス株式会社 logo
Carna Biosciences, Inc.4572

Business

Carna Biosciences is a kinase-specialized drug discovery venture (listed on TSE Growth) that spun off from Japan Organon in 2003. Its business consists of two pillars: the Drug Discovery Business and the Drug Discovery Support Business. In the Drug Discovery Business, the company is conducting clinical development of three pipelines: the BTK inhibitors docirbrutinib (AS-1763) (hematologic cancers) and sofnobrutinib (AS-0871) (immuno-inflammatory diseases), and the CDC7 inhibitor monzosertib (AS-0141) (solid tumors/AML). In the Drug Discovery Support Business, the company provides over 750 types of kinase protein products and profiling services to pharmaceutical companies, biotech ventures, and research institutions worldwide, generating internal funding for the R&D of the Drug Discovery Business. Its main customers are domestic and overseas pharmaceutical companies, CROs, and AI drug discovery companies, and it has developed a sales network across China, North America, and Europe.

Business Model

The Drug Discovery Support Business secures continuous revenue through products and contracted services such as Kinase Protein Sales and Profiling Service, thereby supplementing R&D expenses for the Drug Discovery Business. The Drug Discovery Business follows a model of licensing out the intellectual property rights of drug candidate compounds to pharmaceutical companies and receiving upfront payments, development milestones, and post-launch royalties. In the oncology area, the company conducts development in-house up through Phase 2 at most to enhance pipeline value before out-licensing, while for other areas it adopts a policy of early out-licensing at the Phase 1 or preclinical stage.

Company Strengths

The company holds over 750 types of kinase proteins, including mutants, and over 200 types of biotinylated proteins. It is the only company in the world able to provide profiling services using the Mobility Shift Assay System with SCIEX's BioPhase 8800, demonstrating differentiated competitive advantage in both retaining existing customers and acquiring new ones.

The company out-licensed its DGKα Inhibitor to Gilead (June 2019) for an upfront payment of $20 million, and has received a cumulative total of $35 million following the achievement of two milestones. The joint research collaboration with Sumitomo Pharma in the CNS disease area, ongoing since 2018, was extended in March 2025 through March 2027. A track record of out-licensing to multiple mega-pharma companies, including J&J, Cerevel, and BioNova, underpins the company's credibility.

At ASH2025 in December 2025, docirbrutinib reported promising and durable responses in CLL, MCL, and WM patients with multiple prior lines of therapy. The trial advanced ahead of schedule to the dose expansion part (October 2024), and the number of trial sites expanded to 13. The existing BTK inhibitor market reached approximately $12 billion as of 2024, indicating blockbuster potential.

ENVALITH's Perspective

The company has disclosed that material doubt exists regarding its ability to continue as a going concern, and concluding a docirbrutinib licensing agreement during 2026 is key to its funding situation. Attention is focused on whether new interim results to be presented at EHA2026 (June 2026) will accelerate partnering activities. If contract conclusion is delayed, there is a high risk that additional fundraising (dilution) will become unavoidable.

In 1Q FY2026, the Drug Discovery Support Business turned profitable with operating income of ¥19 million (compared to an operating loss of ¥12 million in the same period of the previous year), confirming improvement. However, performance has been sluggish in the US due to a decline in large protein orders and a temporary decrease in orders from AI drug discovery companies, and recovery in this largest market is a condition for sustained earnings improvement. As an external factor, it should also be noted that the continuation of the AI drug discovery boom will affect the company's order trends.

In February 2026, the company issued its 2nd series of unsecured straight bonds (¥1,850 million) and stock acquisition rights with an exercise price reset clause (7,698,300 potential shares). As of the end of 1Q, net assets stood at ¥(163) million and the equity ratio was (8.1)%, indicating a state of negative net worth. The exercise price of the stock acquisition rights is set to be revised in line with 90% of the share price, creating a risk that fundraising amounts could fall short of expectations if the share price declines. As a subsequent event, partial conversion of convertible bonds (500,801 shares) is progressing, and dilution pressure is expected to continue.

Growth Strategy

Rebuilding the financial foundation through two pillars: securing a large upfront payment via early out-licensing of docirbrutinib, and expanding revenue in the Drug Discovery Support Business

The dose expansion part of the US Phase 1b trial (13 sites nationwide) is underway. Following the presentation of promising interim results at ASH2025 and publication in the Blood Cancer Journal (May 2026), partnering activities will be accelerated through new interim results to be presented at EHA2026 (June 2026). The top priority goal is to conclude a licensing agreement and secure an upfront payment during 2026.

The last patients in the solid tumor dose expansion part and the hematologic malignancy monotherapy trial have completed the study, and data analysis is underway. Preparations for concluding a CTA with MD Anderson Cancer Center in the US are progressing, aiming to initiate an investigator-initiated triple-combination Phase 1b trial targeting AML. Partnering activities will be intensified after data analysis is completed.

The Phase 1 trial has been completed. Differentiating data showing no teratogenicity in embryo-fetal developmental toxicity studies has been obtained, supporting the appeal that there are no usage restrictions for women of childbearing potential. Partnering activities continue, targeting the CSU (chronic spontaneous urticaria) market (projected at approximately $5.4 billion by 2032) as the primary target.

Operating profit turned positive in 1Q FY2026 (¥19 million). The company will continue to expand orders from domestic, European, Chinese, and AI drug discovery customers, while working to achieve recovery in the US. Customer convenience is being enhanced through standalone sales of assay buffers and substrates and utilization of the Kinase Assay Support Portal (available in Japanese, English, and Chinese), promoting product usage and new customer acquisition.

On February 17, 2026, the company issued the 2nd Series Unsecured Straight Bonds (¥1,850 million), stock acquisition rights with exercise price revision clauses (potential shares: 7,698,300), and new shares (46,200 shares), raising a net amount of ¥1,496 million. Proceeds from the exercise of the stock acquisition rights are expected to be applied to the redemption of these bonds. Conversion of the convertible bonds has also partially progressed (subsequent event: 500,801 shares).

Last updated: July 17, 2026