Micot Pharma Reports Positive Operating Cash Flow and Advances Late-Stage Pipeline in 1H 2026

HONG KONG, August 31, 2026 - (ACN Newswire) - Operating Cash Flow Turns Positive for the First Time, with a Significantly Strengthened Capital Structure

On August 28, 2026, Micot Pharma (02335.HK), the first publicly listed peptide-focused innovative drug company in Hong Kong, announced its interim results for the first half of 2026.

During the reporting period, the Company recorded research and development expenses of RMB128 million, representing a significant year-on-year increase of 215.9%, reflecting an acceleration in R&D investment. Meanwhile, net cash generated from operating activities reached RMB109 million, marking a turnaround from net operating cash outflow in the corresponding period of 2025.

An important contributor to this shift was the commercialization partnership for MT1013.

In February 2026, Micot Pharma entered into an exclusive commercialization licensing agreement with Everest Medicines for MT1013, the Company's Core Product. Under the agreement, Everest Medicines was granted exclusive commercialization rights for MT1013 in Greater China and the Asia-Pacific region excluding Japan for the treatment of secondary hyperparathyroidism (SHPT).

Micot Pharma received an upfront payment of RMB200 million and is eligible to receive potential regulatory and commercial milestone payments of up to RMB1.04 billion, as well as tiered royalties based on net product sales.

As of the end of June 2026, the Company's cash and financial assets totaled approximately RMB1.227 billion, compared with RMB270 million at the end of 2025. Total equity reached approximately RMB957 million, compared with net liabilities of approximately RMB960 million at the end of 2025. The Company's gearing ratio also declined substantially from 389.6% to 25.2%.

For a clinical-stage biotechnology company, the strengthening of liquidity and capital structure provides important financial support for the continued advancement of multiple clinical programs.

MT1013 Advances Through Phase III, with a Clearer Path Toward Commercialization

Beyond its financial position, the key question for the market remains the progress and clinical potential of Micot Pharma's pipeline.

MT1013 remains the Company's most advanced asset and the product closest to commercialization.

MT1013 is the world’s first-in-class, new-generation dual-targeting peptide drug being developed for secondary hyperparathyroidism associated with chronic kidney disease (CKD-SHPT).The drug features a pioneering dual mechanism of action—“CaSR agonist + OGP (Osteogenic Growth Peptide) mimetic.”

Unlike conventional approaches that primarily focus on suppressing parathyroid hormone (PTH), MT1013 is designed to regulate PTH, calcium and phosphorus metabolism while simultaneously activating osteogenic pathways to promote bone formation and repair. This represents a potential therapeutic shift from indirectly suppressing bone resorption toward actively promoting bone formation.

The Phase III clinical study of MT1013 has completed patient enrollment, and the Company expects to submit a New Drug Application (NDA) in early 2027.

In a head-to-head clinical study against the calcimimetic etelcalcetide, the composite target attainment rate for serum calcium, phosphorus, and iPTH in the MT1013 groups after 20–27 weeks of treatment was 39.29% and 34.48%, respectively, approximately 2.2–2.5 times that of etelcalcetide (15.63%).

In addition, the proportion of patients in the MT1013 groups achieving a reduction of more than 30% in intact parathyroid hormone (iPTH) from baseline reached 83.9%–93.3%.

Clinical data from MT1013 have also been accepted as Late-Breaking Science by the American Society of Nephrology (ASN) Kidney Week.

Against this backdrop, Micot Pharma's commercialization partnership with Everest Medicines represents an important step in translating the clinical and scientific value of MT1013 into potential commercial value.

Positive Phase II Data for MT200605 Further Validate Its Potential as an Innovative Stroke Therapy

Shortly before the release of its interim results, Micot Pharma announced on August 26 that it had completed the Phase II clinical trial of MT200605, its internally developed candidate for the treatment of acute ischemic stroke (AIS).

The study was a multicenter, randomized, double-blind, placebo-controlled Phase II trial involving 360 patients, who were randomized at a 1:1:1:1 ratio into three MT200605 dose groups and a placebo group.

For the primary efficacy endpoint, the proportion of patients achieving a modified Rankin Scale (mRS) score of 0–1 in the high-dose MT200605 group was higher than that in the placebo group, with the odds ratio (OR) for functional recovery improving by more than 100% versus placebo.

From a clinical-benefit perspective, the results suggest that approximately one additional patient could achieve functional independence for every six patients treated.

The signal is noteworthy in the context of neuroprotection research, a field in which translating biological mechanisms into meaningful improvements in functional outcomes has historically been challenging.

For the secondary endpoints, improvement in National Institutes of Health Stroke Scale (NIHSS) scores in the high-dose group began to separate from placebo by Day 7. The direction of improvement was consistent with the mRS results, with a more pronounced difference observed by Day 14, suggesting faster early neurological recovery among patients receiving high-dose MT200605.

Another differentiated observation involved acute kidney injury (AKI).

MT200605 demonstrated the potential to reduce the incidence of AKI among patients with AIS in a dose-dependent manner. In the high-dose group, the incidence of AKI was more than 80% lower than that in the placebo group, indicating potential renal-protective benefits in addition to its neurological effects.

A Differentiated BDNF/TrkB-Based Mechanism Supporting Potential Brain and Kidney Protection

Mechanistically, MT200605 is a small molecule compound that acts as a tropomyosin receptor kinase B (TrkB) agonist with brain-derived neurotrophic factor (BDNF)-like effects.

By activating TrkB, it modulates downstream signaling pathways to protect the structure and function of brain neural tissues. Additionally, it enhances mitochondrial ATP synthesis and exerts antioxidant effects by scavenging oxygen free radicals.

This differentiated mechanism may also contribute to the renal-protective signal observed in the Phase II trial.

MT200605 has received recognition from both domestic and international scientific and regulatory communities. The program has been selected for China's National Science and Technology Major Project for Innovative Drug Development. Its preclinical and Phase I clinical findings have also been accepted for oral presentation at the 18th World Stroke Congress.

In addition, the U.S. Food and Drug Administration granted Orphan Drug Designation to MT200605 for the treatment of Huntington's disease in March 2026.

A Multi-Layered Pipeline Strengthens Micot Pharma's Capacity for Sustained R&D Output

Beyond MT1013 and MT200605, Micot Pharma is building a broader pipeline spanning different stages of clinical development.

XTL6001, a GLP-1R/GCGR/MasR triple agonist, has completed database lock for its Phase I clinical trial. By incorporating MasR into its mechanism of action, XTL6001 is designed to extend its therapeutic potential beyond weight management and metabolic regulation toward renal protection and anti-inflammatory and anti-fibrotic effects.

Research relating to XTL6001 has been accepted for presentation at several major international scientific conferences, including the American Diabetes Association (ADA) Scientific Sessions 2026, the European Association for the Study of Diabetes (EASD) Annual Meeting 2026 and ASN Kidney Week 2026.

Meanwhile, MT1002 continues to advance across indications including anticoagulation during hemodialysis and acute ischemic stroke, further expanding Micot Pharma's development footprint in cardiovascular, cerebrovascular and renal diseases.

Entering an Accelerated Validation Phase for R&D Outcomes

Taken together, the most important takeaway from Micot Pharma's 2026 interim results is not whether a clinical-stage biotechnology company can achieve near-term profitability.

Rather, three developments are taking place simultaneously.

First, MT1013 has entered the critical late-stage clinical development period ahead of a potential NDA submission, while its commercialization partnership with Everest Medicines has established a clearer pathway toward commercialization.

Second, the Phase II results of MT200605 have provided further clinical evidence supporting the therapeutic potential of its differentiated mechanism in acute ischemic stroke.

Third, proceeds from the Company's Hong Kong listing, together with the upfront payment received under the MT1013 commercialization agreement, have substantially strengthened Micot Pharma's liquidity and capital structure, providing greater financial flexibility to advance its clinical pipeline.

For investors and industry observers, these developments may represent the central theme through which Micot Pharma's first interim results following its Hong Kong listing should be understood: the Company is moving from a stage dominated by R&D investment toward one in which clinical progress, external partnerships and pipeline value are increasingly being validated through tangible milestones.