MEDICINOVA INC DE false 0001226616 0001226616 2025-03-11 2025-03-11
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 OR 15(d)
of The Securities Exchange Act of 1934
Date of Report (date of earliest event reported): March 11, 2025
MEDICINOVA, INC.
(Exact name of registrant as specified in charter)
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| DELAWARE |
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001-33185 |
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33-0927979 |
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(Commission File Number) |
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(I.R.S. Employer Identification No.) |
| 4275 EXECUTIVE SQUARE, |
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| SUITE 300, LA JOLLA, CA |
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92037 |
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(Zip Code) |
Registrant’s telephone number, including area code: (858) 373-1500
Not applicable.
(Former name or former address, if changed since last report.)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
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Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
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Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
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Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
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Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Securities registered pursuant to Section 12(b) of the Act:
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| Common Stock, $0.001 par value |
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MNOV |
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The Nasdaq Stock Market LLC |
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(Name of each exchange
on which registered) |
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (17 CFR §230.405) or Rule 12b-2 of the Securities Exchange Act of 1934 (17 CFR §240.12b-2).
Emerging growth company ☐
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
On March 11, 2025, MediciNova, Inc. (the “Company”) updated the slide presentation to be used by the Company at investor meetings. A copy of the revised slide presentation is furnished as Exhibit 99.1 to this Current Report on Form 8-K (the “Report”) and is incorporated herein by reference. The Company does not undertake to update this presentation.
The information in this Report, including Exhibit 99.1 hereto, is being furnished and shall not be deemed “filed” for the purposes of Section 18 of the Securities Exchange Act of 1934, as amended (“Exchange Act”), or otherwise subject to the liabilities of that Section, and shall not be deemed incorporated by reference in any registration statement or other filing pursuant to the Securities Act of 1933, as amended, or the Exchange Act, except as otherwise expressly stated in such filing.
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Financial Statements and Exhibits. |
(d) Exhibits.
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
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| Date: March 11, 2025 |
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MEDICINOVA, INC. |
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By: |
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/s/ Yuichi Iwaki |
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Yuichi Iwaki |
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President and Chief Executive Officer |
Exhibit 99.1 MediciNova Corporate Presentation March 2025
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 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 simil ar 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, 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 la ter 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 MediciNov a'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 Securi ties and Exchange Commission, including its
annual report on Form 10-K for the year ended December 31, 2024 and its subsequent periodic reports on Forms 10-Q and 8-K. MediciNova disclaims any intent or obligation to revise or update these forward-looking statements. © MediciNova, Inc.
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MediciNova Overview ✓ US Office: San Diego; Japan Office: Tokyo
• Dual listed in TSE JASDAQ (4875) and NASDAQ (MNOV) ✓ Biopharma company developing late-stage drug candidate • Multiple late-stage pipelines (Phase 2/3, Phase 2) • Well-established safety profile ✓ Focused on unmet
medical needs • MN-166 (ibudilast):Neurodegenerative disease, Brain tumor • MN-001(tipelukast): Metabolic diseases (Hyperlipidemia/T2DM, NAFLD (MAFLD)) ✓ Capital efficient model • Operating cash burn ~ $12 M/year •
Royalty income from out-licensed program (Sanofi/Genzyme) • Majority funding for MNOV Clinical trials have been sponsored by the US and/or other government agencies. © MediciNova, Inc. 3
MNOV Core Pipelines Phase 1 Phase 2 Phase 3 Indication MN-166
(ibudilast) * ALS (Amyotrophic Lateral Sclerosis) * Orphan disease, Fast Track ** Brain Tumor (Glioblastoma Brain metastasis) ** Fast Track Acute Lung Injury / Sever Pneumonia MN-001 (tipelukast) 5 Type 2 DM+ Hyper TG + NAFLD SAR 444836 (AAV gene
therapy) Out-licensed to Sanofi/Genzyme 5 PKU (Phenylketonuria ) © MediciNova, Inc. 4
Academia Partnered Programs • All non-core programs are FULLY
FUNDED by public/government agencies, run by academia researchers from reputable institutions in US, UK, Australia, and Canada • Upon completion MNOV has full rights for regulatory applications with ZERO development expenses • MNOV then
has exclusive rights to commercialization, following regulatory filings © MediciNova, Inc. 5
MN-166 Ibudilast 6
MN-166 Overview CODE MN-166 Description Small Molecule Chemical Name
Ibudilast Administrate Route Oral I.V. injection Mechanism of Action Multiple MOAs (MOA) MIF (macrophage inhibitory factor) inhibitor PDE (phosphodiesterase) 3, 4, 10, and 11 inhibitor TLR4 ( Toll-Like-Receptor 4) inhibitor Clinical effect Reduce
neuroinflammation Neuro-protection Tumor microenvironment modification © MediciNova, Inc. 7
Positive outcome from first Phase 2 ALS study (MN-166-ALS-1201) Study
Summary • Single-center (PI: Dr. Brooks, Carolina Neuromuscular ALS MDA Center), R(1:2), PCT, DB followed by OLE • Target ALS patients (ALS history ~ 5 years), on Riluzole treatment • Treatment: 60 mg/day MN-166 or Placebo X 6
months followed by 6-mo OLE • Total 51 patients enrolled R=Randomized , PCT=placebo-control , DB=double-blind, OLE=Open-Label-Extension Responder Anlaysis Outcome Responder Category Placebo (n=16) MN-166 (n=33) +Riluzole +Riluzole ALSFRS-R
Stable or improved from baseline 2/16 (12.5%) 7/33 (21.2%) ALSAQ-5 4/16 (25%) 17/33 (51.5%) (QOL) MMT 4/16 (25%) 11/33 (33.3%) (muscle strength) Results: More responders in MN-166 treatment group © MediciNova, Inc. Ref: Oskarsson B, et al.
Neurodegener Dis Manag. 2021 Dec;11(6) 8
Ongoing Phase 2/3 ALS study (COMBAT-ALS / MN-166-ALS-2301) Study Sites :
Multi-centers in US and Canada Study Design : R (1:1), PCT, DB study followed by OLE Target Patients: Early-stage ALS (ALS history within 18 mo ) Dose : 100mg/day or placebo Treatment Duration : 12-mo DB, 6-mo OLE Size: N=230 (randomized) Primary
Endpoint : Change from baseline in ALSFRS-R score at Month 12 and survival time (global rank test) Secondary Muscle strength (HHD), Quality of Life (ALSAQ-5)Responder Analysis (ALSFRS-R) Endpoint : Survival time, Safety and tolerability Study status
: As of Dec 2024, total 228 enrolled, 193 randomized © MediciNova, Inc. 9
Upcoming NIH funding Expand Access ALS study (SEA-NOBI-ALS) Sponsor :
NIH NINDS (National Institute of Neurological Disorders and Strokes ) Funding Amount : $ 22 M Lead PI : Mayo Clinic Dr. Oskarsson Study Sites : Multi-centers in US (approx. 20 sites) Study Design: Open-Label study Target Patients: Late-stage ALS
patients (ALS history > 36 months) or VC (respiratory function) < 50 % Dose : 60 mg/day Treatment Duration : 6 month Size : N=200 Primary Plasma NfL (Neurofilament Light) Concentration Endpoint : ALSFRS-R score Secondary ALSAQ-5 (QOL), Neuro
QOL, inflammatory cytokines assay Endpoint: Study status : Plan to enroll first patient in 2Q 2025 © MediciNova, Inc. 10
Positive outcome from first Phase 1/2 GBM study (MN-166-GBM-1201 )
Study Summary • Single-center (PI: Dr. Wen, Dana-Farber Cancer Institute), Open-Label study • GBM patients on Standard of Care (TMZ chemo-therapy) • Treatment: 100 mg/day MN-166 with up to TMZ chemo-therapy 12 cycles • Total
62 patients (26 recurrent, 36 newly Dx) Results: MN-166 was safe and well tolerated with TMZ treatment PFS rate at 6 mo was higher in the recurrent GBM cohort than historical control. Gilbert Youssef at 2024 ASCO © MediciNova, Inc.
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Positive outcome from first Phase 2 COVID-19 ARDS risk study
(MN-166-COVID19-201 ) Study Summary • Multi-center (PI: Dr. Wyler Dr. Sauler), R(1:1), RCT, DB • Severe hospitalized COVID-19 patients with ARDS risk factor (i.e. Age, Medical History, Obesity) • Treatment: 100 mg/day or placebo 7
days • Total 34 patients randomized Outcome MN-166 (n=17) Placebo (n=17) Difference Recovered from Respiratory Failure by Day 7 12/17 (70.6%) 6/17 ( 35.3%) 35.3% (p=0.0196) Improved NIAID8-point score by Day 7 12/17 (70.6%) 8/17 (47.1%) 23.5%
( p=0.0817) Discharged from hospital by Day 7 11/17 (64.7%) 5/17 (29.4%) 35.3 % ( p=0.0196) All cause mortality 0 /17 (0%) 2/17 ( 11.8%) Results: More MN-166 treatment group recovered from respiratory failure and discharged from hospital by Day 7 No
deaths from MN-166 group, 2 deaths from placebo group Ref: MN-166-CODIV19-201 CSR © MediciNova, Inc. 12
MN-001 Tipelukast 13
MN-001 Overview CODE MN-001 Description Small Molecule Chemical Name
Tipelukast Administrate Route Oral Mechanism of Action Multiple MOA (MOA) Leukotriene & 5-lipoxygenase (5-LO) pathway inhibitor PDE (phosphodiesterase) 3,4 inhibitor Clinical effect Anti-inflammation Reduce serum triglyceride Reduce CD36
expression and inhibits the uptake of arachidonic acid into hepatocytes © MediciNova, Inc. 14
Positive outcome from first Phase 2 NAFLD/ NASH + HyperTG study
(MN-001-NATG-201) Study Summary • Multi-center, Open-Label study in US • NAFLD/NASH patients with Hyper TG • Treatment : 250 mg/day x 4 weeks followed by 500 mg/day x 8 weeks • Total 19 patients enrolled Serum TG level
(mg/dL) Serum HDL-C level (mg/dL) Timepoints All subjects With T2DM w/o T2DM All subjects With T2DM w/o T2DM (n=19) (n=10) (n=9) (n=19) (n=10) (n=9) Baseline 345.7 444.7 235.7 38.7 36 41.8 Week 8 206.9 218.8 193.8 41.9 41.7 42.2 Mean % change from -
40.2% -50.8% -17.8% + 8.3% +15.8% +0.9% (p=0.098) (p<0.0002) Baseline (p-value) Results: The subjects with T2DM had a reduction in serum TG levels (-50.82%, p=0.098 ) and significant increase (+ 15.8%, p<0.0002) in HDL-C levels at Week 8 Ref:
MN-001-NATG-201 CSR © MediciNova, Inc. 15
Ongoing Phase 2 HyperTG + T2DM + NAFLD study (MN-001-NATG-202) Study
Sites : 2 centers in US Study Design : R (1:1), PCT, DB study • Jubilee Clinical Research Center o PI: Dr. Shin • South Texas Research Institute o PI: Dr. Patil Target Patients : HyperTG + T2DM+ NAFLD Dose : 500mg/day or placebo
Treatment Duration : 24 Weeks Size : N=40 (randomized) Change from baseline in Controlled Attenuation Parameter score by Fibroscan at Week 24 Primary Endpoint : Change from baseline in fasting serum TG level at Week 24 Secondary Evaluate the safety
and tolerability of MN-001 Endpoint : Evaluate the effect of MN-001 on lipid profile (i.e., HDL-C, LDL-C, total cholesterol level) Study status : As of Dec 2024, total 43 enrolled, 26 randomized © MediciNova, Inc. 16
CONTACT: Yuichi Iwaki, MD, PhD David H. Crean, PhD Thank you !
CEO/President Chief Business Officer iwaki@medicinova.com crean@medicinova.com © MediciNova, Inc. 17
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