MediciNova Corporate Presentation

Forward-Looking Statements

Statements in this presentation 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 statements regarding MediciNova's clinical trials supporting the safety and efficacy of its product candidates and the potential novelty of such product candidates as treatments for disease, plans and objectives for clinical trials and product development, strategies, future performance, expectations, assumptions, financial condition, liquidity and capital resources. These forward-looking statements include, without limitation, statements regarding the future development and efficacy of MN-166,MN-221,MN-001, and MN-029. 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,MN-221,MN-001, and MN-029 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, risks related to MediciNova's reliance on the success of its MN-166 and MN-001 product candidates, 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, 2023 and its subsequent periodic reports on Forms 10-Q and 8-K. Undue reliance should not be placed on these forward-looking statements, which speak only as of March 15, 2024. MediciNova disclaims any intent or obligation to revise or update these forward-looking statements.

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MediciNova's mission is to develop promising new therapeutics for the treatment of diseases with high unmet medical needs.

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MediciNova Overview

Late-stage biopharma company developing oral, anti-inflammatory candidates with well-established safety and efficacy profiles

  • Differentiated product profiles have potential to meet needs of patients across a wide range of indications
  • Targeting large, underserved, markets

Robust pipeline focused on neurological, fibrotic, and other diseases with no or inadequate treatment options

  • MN-166(ibudilast): targeting CNS disorders with high unmet needs, including Phase 3 programs in ALS and DCM
    • Progressive MS program is Phase 3 ready
    • Other programs in ARDS, glioblastoma, CIPN, substance dependence, and Long COVID
  • MN-001(tipelukast): Phase 2 for NAFLD

Well-funded with capital efficient business model

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Robust Pipeline Targeting High Unmet Needs

Core Programs / Indications

Phase 1

Phase 2

Phase 3

MN-166 (ibudilast), Oral Anti-Inflammatory / Neuroprotective Therapeutic

Long COVID

COVID-19 ARDS

Progressive Multiple Sclerosis

Neurodegenerative Diseases

NeuroNEXT / Cleveland Clinic (Funded by NINDS)

ALS (Amyotrophic Lateral Sclerosis)

Carolinas / Massachusetts General Hospital (MGH)

Degenerative Cervical Myelopathy (DCM)

University of Cambridge (Funded by NIHR in the UK)

Chemotherapy-Induced Peripheral Neuropathy (CIPN)

University of Sydney (Funded by Concord Cancer Centre)

Glioblastoma (GBM)

Dana-Farber Cancer Institute

Substance Dependence

Methamphetamine Dependence

UCLA / Oregon Health & Science (Funded by NIDA / VA)

Opioid Dependence

Columbia University (Funded by NIDA)

Alcohol Dependence

UCLA (Funded by NIAAA / NIDA)

FT

  • FT

FT

MN-001 (tipelukast), Oral Anti-Inflammatory /Anti-Fibrotic Therapeutic

Nonalcoholic Fatty Liver Disease (NAFLD) / NASH

FT

IPF (Idiopathic Pulmonary Fibrosis)

FT

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Orphan Drug FT Fast Track

MN-166

Ibudilast

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MN-166 (ibudilast) Overview

Oral, anti-inflammatory neuroprotective candidate

  • Well established safety and tolerability profile
  • Approved in Japan for post-stroke dizziness / asthma (~3 MM patients)

Late-stage development across major indications

  • Phase 3 trials in Amyotrophic Lateral Sclerosis (ALS) and Degenerative Cervical Myelopathy (DCM) are ongoing
  • Phase 3 ready in progressive multiple sclerosis (MS)
    • Phase 2 data shows potential for strong efficacy in Secondary Progressive MS without Relapse for which there are no approved drugs
  • Completed Phase 2 trial in COVID-19 ARDS with positive results

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MN-166 (ibudilast): Multiple Mechanisms of Action

MICROGLIA STIMULATORS

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MIF Inhibition

  • Linked to attenuated disease progression in animal models of MS

PDE 4 Inhibition

  • Increases cAMP
  • Reduces pro-inflammatory cytokines (i.e. IL-1,TNF-α,IL-6)
  • Neuroprotection

Glial Cell Attenuation

  • Role of Glia:
    • Type of macrophage
    • Activated during brain damage
    • Glial activation leads to neurodegeneration

Amyotrophic Lateral Sclerosis (ALS) Landscape

ALS AFFECTS

LIFE EXPECTANCY

An effective new drug for

APPROVED DRUGS

ALS could generate sales of

RILUZOLE

~16K

2-5

Increases survival by

2

ONLY 2-3 months3

$

1B+

RADICAVA

No survival benefit on label4

People in United States1

Years1

RELYVRIO

Limited efficacy data5

No Phase 3 data

ORPHAN

FATAL

EXPECTED MARKET

QALSODY

INDICATION

OPPORTUNITY

Approved for SOD1-ALS6

which affects 2% of ALS patients

MN-166 (ibudilast) Advantages:

  • Potential to improve survival compared to standard of care
  • No serious safety issues (other ALS drugs have Warnings on the labels)

1. Source: ALS Association; 2. Source: Cowen & Co. estimate; 3. Cochrane Database of Systematic Reviews; 4. Radicava prescribing information; 5. Relyvrio prescribing information;

6. Qalsody prescribing information.

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Positive Phase 2 Results in ALS

Achieved Primary Endpoint

Safety And Tolerability

Efficacy Trends

ALSFRS-R Responders

  • N=51 ALS subjects not using non-invasive ventilation
  • MN-166(ibudilast) demonstrated a favorable safety and tolerability profile
  • 7 serious adverse events (SAEs) but none were related to the study drug
  • All treatment-related adverse events (TRAEs) were mild to moderate
    • No severe or life-threatening TRAEs
    • Most frequently reported TRAEs: nausea, anorexia, and loss of appetite were expected and are common side effects of both riluzole and MN-166 (ibudilast)
  • Responder was defined as a subject who improved on the ALSFRS-R total score*, had no change on the score, or the score declined by 1 point
  • 6-month, Double-BlindPeriod: 29.4% of subjects in the MN-166 (ibudilast) group were responders compared to 17.6% of subjects in the placebo group
  • 6-month, Open-LabelExtension (OLE): 35.3% of subjects on placebo in the double-blind period were responders when taking MN-166 (ibudilast) in OLE

*Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised(ALSFRS-R) total score measures the functional activity of an ALS subject. ALS subjects decline on the ALSFRS-R total score over time as the disease progresses and their symptoms worsen.

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MediciNova Inc. published this content on 15 March 2024 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 15 March 2024 22:36:08 UTC.