MediciNova CEO Provides Shareholder Update
Dear Fellow Shareholders,
Below outlines our progress over the first half of the year, which includes strengthening of our intellectual property portfolio, continued pipeline development, and cultivating relationships in the market to increase our investor awareness. Inclusive of these activities, we attended the annual meeting of BIO2026 in our hometown of
Clinical Development Highlights
MN-166 (ibudilast)
SEANOBI Study Expanded-Access-Program (EAP) Evaluating MN-166 (ibudilast) in ALS patients: Earlier this year, the Company announced that 12 sites in the
Notice of Allowance for
Peer Reviewed Study on Ibudilast Highlighting its Role in Preventing Brain Metastases: Researchers at the Spanish National Cancer Research Centre (CNIO) identified macrophage migration inhibitory factor (MIF)–mediated reprogramming of CD74-positive microglia and macrophages as a central vulnerability in brain metastasis. The research, recently published in the peer-reviewed journal “Cancer Research” (
MN-001 (tipelukast)
Completion of Last Patient Last Visit: The completion of last patient last visit (LPLV) was achieved in its Phase 2 clinical trial, MN-001-NATG-202, evaluating MN-001 (tipelukast) for the treatment of hypertriglyceridemia and nonalcoholic fatty liver disease (NAFLD) associated with type 2 diabetes mellitus (T2DM). The MN-001-NATG-202 study is a multicenter, randomized, double-blind, placebo-controlled trial evaluating MN-001 (tipelukast). Top-line data are expected in the third quarter of 2026.
Business and
A clinical story is only as valuable as the market's ability to see it. Eighteen months ago, one equity research firm covered
For a company of our market capitalization, that is not a routine development. We believe it is a signal that the institutional research community sees the late-stage pipeline, the year-end ALS readout, and the capital-efficient model as worth the desk's time. We welcome the scrutiny. Coverage builds the audience that data will eventually convince.
As we move to the second half of 2026, we believe that we have good momentum to continue reaching our milestones, especially an upcoming key catalyst at the end of 2026 related to the topline data for our COMBAT ALS Phase 2b/3 Registration trial, while prudently and carefully managing our finances. We remain committed to helping better the lives of our patients suffering from serious diseases, as well as creating long-term value for our shareholders and we look forward to providing additional updates as they develop.
Thank you for your continued support and faith in the
President & CEO
About MediciNova
MediciNova, Inc. is a clinical-stage biopharmaceutical company developing a broad late-stage pipeline of novel small molecule therapies for inflammatory, fibrotic, and neurodegenerative diseases. Based on two compounds, MN-166 (ibudilast) and MN-001 (tipelukast), with multiple mechanisms of action and strong safety profiles, MediciNova has numerous programs in clinical development. MediciNova’s lead asset, MN-166 (ibudilast), is currently in Phase 3 for amyotrophic lateral sclerosis (ALS) and degenerative cervical myelopathy (DCM) and is Phase 3-ready for progressive multiple sclerosis (MS). MN-166 (ibudilast) is also being evaluated in Phase 2 trials in Long COVID and substance dependence. MN-001 (tipelukast) was evaluated in a Phase 2 trial in idiopathic pulmonary fibrosis (IPF) and a second Phase 2 trial in non-alcoholic fatty liver disease (NAFLD) is ongoing. MediciNova has a strong track record of securing investigator-sponsored clinical trials funded through government grants.
Statements in this press release that are not historical in nature constitute forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, without limitation, statements regarding the future development and efficacy of MN-166 and MN-001. These forward-looking statements may be preceded by, followed by, or otherwise include the words "believes," "expects," "anticipates," "intends," "estimates," "projects," "can," "could," "may," "will," "would," “considering,” “planning” or similar expressions. These forward-looking statements involve a number of risks and uncertainties that may cause actual results or events to differ materially from those expressed or implied by such forward-looking statements. Factors that may cause actual results or events to differ materially from those expressed or implied by these forward-looking statements include, but are not limited to, risks of obtaining future partner or grant funding for development of MN-166 and MN-001, and risks of raising sufficient capital when needed to fund MediciNova's operations and contribution to clinical development, risks and uncertainties inherent in clinical trials, including the potential cost, expected timing and risks associated with clinical trials designed to meet FDA guidance and the viability of further development considering these factors, product development and commercialization risks, the uncertainty of whether the results of clinical trials will be predictive of results in later stages of product development, the risk of delays or failure to obtain or maintain regulatory approval, risks associated with the reliance on third parties to sponsor and fund clinical trials, risks regarding intellectual property rights in product candidates and the ability to defend and enforce such intellectual property rights, the risk of failure of the third parties upon whom MediciNova relies to conduct its clinical trials and manufacture its product candidates to perform as expected, the risk of increased cost and delays due to delays in the commencement, enrollment, completion or analysis of clinical trials or significant issues regarding the adequacy of clinical trial designs or the execution of clinical trials, and the timing of expected filings with the regulatory authorities, MediciNova's collaborations with third parties, the availability of funds to complete product development plans and MediciNova's ability to obtain third party funding for programs and raise sufficient capital when needed, and the other risks and uncertainties described in MediciNova's filings with the Securities and Exchange Commission, including its annual report on Form 10-K for the year ended December 31, 2025 and its subsequent periodic reports on Form 10-Q and current reports on Form 8-K. Undue reliance should not be placed on these forward-looking statements, which speak only as of the date hereof. MediciNova disclaims any intent or obligation to revise or update these forward-looking statements.
INVESTOR CONTACT:
David H. Crean, Ph.D.
Chief Business Officer
MediciNova, Inc
info@medicinova.com
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