MediSync, Inc. H1 2026 Earnings Deep Dive

1. Executive Summary

For the first half of the fiscal year ending December 2026, biopharmaceutical developer MediSync, Inc. (TSE Standard: 4875 / NASDAQ: MNOV) achieved significant milestones and made substantial progress toward data disclosure across its multiple clinical pipelines.

Financially, the company saw operating revenue grow to 103,732 thousand JPY (an increase of 82,100 thousand JPY year-on-year) . Meanwhile, through the optimization of R&D expenditures, the operating loss narrowed to -864,190 thousand JPY (a reduction in deficit of 230,249 thousand JPY year-on-year) , and the net loss for the period improved to -787,591 thousand JPY (a reduction in deficit of 200,082 thousand JPY year-on-year) . The company maintains a solid cash position with 4,084,846 thousand JPY (approx. 4.08 billion JPY) in cash and cash equivalents , ensuring a stable foundation for continued pipeline development.

In terms of business development, clinical trials for the two core compounds, "MN-166 (ibudilast)" and "MN-001 (tipelukast)," have reached the completion and evaluation phases. Notably, the MN-001 trial for hypertriglyceridemia/non-alcoholic fatty liver disease (NAFLD) has completed database lock, with top-line data expected by the end of September 2026 . Furthermore, the Phase 2b/3 trial for MN-166 in amyotrophic lateral sclerosis (ALS) (COMBAT-ALS) has completed its double-blind evaluation, with top-line data scheduled for release by the end of 2026 . Major catalysts directly impacting corporate value are imminent.

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2. Financial Highlights and Analysis of Profit Structure

Comparative Analysis of the Income Statement (3-Period Comparison)

MediSync’s financial performance for the first half of the fiscal year ending December 2026 reflects simultaneous revenue growth and cost containment compared to the same period last year.

As shown in the slide above, operating revenue increased significantly from 21,632 thousand JPY in the same period last year to 103,732 thousand JPY (+379.5%) . On a quarterly basis, revenue showed steady growth from 30,052 thousand JPY in Q1 to 73,680 thousand JPY in Q2.

Structural changes have occurred on the expense side in line with R&D strategy progress:

• R&D and Patent Expenses : Decreased significantly from 647,453 thousand JPY in the same period last year to 368,318 thousand JPY (a decrease of 279,135 thousand JPY, or -43.1%) . This is attributed to the completion of patient enrollment for large-scale clinical trials and the transition to data analysis and evaluation phases, as well as efficient development utilizing external research institutions and grants.
• SG&A Expenses : Increased from 449,919 thousand JPY in the same period last year to 549,655 thousand JPY (+99,736 thousand JPY) .
• Cost of Service Revenue : Recorded at 49,948 thousand JPY (+31,249 thousand JPY year-on-year).

As a result, total operating expenses were contained at 967,923 thousand JPY (a decrease of 148,148 thousand JPY year-on-year) , leading to an operating loss of -864,190 thousand JPY , a reduction in the deficit of 230,249 thousand JPY compared to the -1,094,439 thousand JPY recorded in the same period last year. After accounting for non-operating income, such as interest income of 77,932 thousand JPY, the net loss for the period was -787,591 thousand JPY , a significant improvement from the -987,673 thousand JPY in the same period last year.

Financial Position and Cash Flow

• Assets : Total assets stand at 6,498,467 thousand JPY , with cash and cash equivalents accounting for 4,084,846 thousand JPY , the majority of current assets.
• Liabilities and Net Assets : Total liabilities remain low at 508,335 thousand JPY , with shareholders' equity at 5,990,131 thousand JPY , maintaining an extremely healthy equity ratio of approximately 92.2% .
• Cash Flow : Cash flow from operating activities was -866,322 thousand JPY (compared to -978,795 thousand JPY in the same period last year), confirming the containment of the burn rate.

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3. Pipeline Progress and Development Structure

MediSync effectively combines an in-house development model with an out-licensing/co-development model leveraging external partners (universities, public research institutions, and grants) to advance its pipeline while diversifying development risks and financial burdens.

The progress of the major pipelines currently underway is summarized below:

Summary of Major Pipeline Progress

1. MN-166 (ALS / COMBAT-ALS) : Phase 2b/3 | Patient enrollment completed / Double-blind evaluation expected to be completed (In-house development / Fast Track & Orphan Drug designation)
2. MN-166 (ALS / SEANOBI-ALS) : Expanded Access Program (EAP) | Target of 200 enrollments achieved (NIH grant approx. 3 billion JPY / Mayo Clinic partnership)
3. MN-166 (Degenerative Cervical Myelopathy / DCM) : Phase 2b/3 (RECEDE) | Planned enrollment reached (64 patients enrolled) (NIHR grant / Led by University of Cambridge)
4. MN-166 (Chemotherapy-Induced Peripheral Neuropathy / CIPN) : Phase 2b (OXTOX) | Last Patient Last Visit completed (AGITG grant / University of Sydney partnership)
5. MN-166 (Glioblastoma / Malignant Brain Tumor) : Phase 2 | Clinical Study Report (CSR) submitted / New patent granted (In-house development / Fast Track designation)
6. MN-001 (Type 2 Diabetes, Hypertriglyceridemia, NAFLD) : Phase 2 (MN-001-NATG-202) | Database lock completed (In-house development / Fast Track designation)

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4. Clinical Progress of Core Compound "MN-166 (ibudilast)"

MN-166 (ibudilast) is a small-molecule oral compound with MIF (macrophage migration inhibitory factor) inhibitory action and phosphodiesterase (PDE-3, 4, 10) inhibitory action , possessing both anti-inflammatory and neuroprotective properties.

(1) Amyotrophic Lateral Sclerosis (ALS) Program

• COMBAT-ALS (Phase 2b/3 trial / In-house development) :
  • Completed enrollment of 234 patients in September 2025, followed by a 12-month double-blind phase and a 6-month open-label extension.
  • Final patient evaluation for the double-blind phase is expected to be completed within September 2026 . Following data cleanup and database lock, top-line data is scheduled for release by the end of 2026 .
  • Received Fast Track and Orphan Drug designations from the FDA, which are expected to accelerate development upon positive results.
• SEANOBI-ALS (Expanded Access Program / EAP) :
  • Conducted under the leadership of the Mayo Clinic with approx. 3 billion JPY in funding from the National Institutes of Health (NIH).
  • A program providing treatment opportunities to severe patients who do not meet standard trial eligibility criteria; achieved the target enrollment of 200 patients in July 2026 . Final patient evaluation is scheduled for February 2027.

(2) DCM and CIPN Programs

• DCM (RECEDE trial) : Led by the University of Cambridge with funding from the UK NIHR. As of the end of August 2026, 64 patients have been enrolled , reaching the target. The company has entered discussions with the principal investigator regarding the data analysis plan.
• CIPN (OXTOX trial) : A Phase 2b trial in Australia targeting peripheral neuropathy associated with oxaliplatin. The last patient last visit was completed in August 2026 , and top-line data is expected in the second half of 2026 .

(3) Oncology (Glioblastoma)

• The Clinical Study Report (CSR) for the combination trial with temozolomide has been submitted to the FDA . In June 2026, a new patent regarding the "combination therapy of MN-166 and immune checkpoint inhibitors (PD-1 antibodies)" was granted in the U.S., strengthening the intellectual property foundation.

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5. Progress of Metabolic Disease Compound "MN-001 (tipelukast)"

MN-001 possesses leukotriene receptor antagonist , PDE-3/4 inhibitory , and 5-lipoxygenase inhibitory properties, and is expected to improve lipid metabolism and provide anti-fibrotic effects.

• NAFLD / Hypertriglyceridemia (MN-001-NATG-202 / Phase 2) :
  • A placebo-controlled, double-blind comparative trial involving 40 patients with hypertriglyceridemia and non-alcoholic fatty liver disease (NAFLD) caused by type 2 diabetes.
  • Following the last patient visit in May 2026, database lock was completed on September 9, 2026 .
  • Top-line data is scheduled for release by the end of September 2026 , with attention focused on the verification of improvements in liver fat content (Fibroscan CAP score) and triglyceride levels.

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6. Future Key Milestones and Conclusion

The second half of 2026 is a critical period for MediSync, as the results of years of clinical development are set to converge.

List of Upcoming Catalysts

• End of September 2026 : MN-001 (NAFLD/Hypertriglyceridemia) Phase 2 top-line data release
• Second half of 2026 : Receipt of MN-166 (CIPN) Phase 2b top-line data
• By the end of 2026 : MN-166 (ALS/COMBAT-ALS) Phase 2b/3 double-blind top-line data release
• February 2027 : Completion of MN-166 (ALS/SEANOBI-ALS) EAP final patient evaluation

By skillfully combining a strong cash position (approx. 4.08 billion JPY) with external research grants, the company is maintaining financial discipline while accumulating clinical data across neurodegenerative diseases, oncology, and metabolic diseases. The content of the top-line data for each pipeline will be a decisive factor in future licensing negotiations with major pharmaceutical companies and the advancement of in-house development to the next phase.