2023 年 2 月 28 日

Zacks Small-Cap Research による当社レポートの発表に関するお知らせ
現地時間の 2 月 27 日、米国シカゴに本拠を置く投資家向け情報サービス企業 Zacks SmallCap Research の David Bautz 氏による、当社レポートが発表されましたので、参考情報としてお知らせいたします。
なお、当該レポートは、恐れ入りますが、権利の都合上、英文のままでのご案内となります
ので、ご了承ください。
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MediciNova,Inc.（メディシノバ・インク）東京事務所 IR 担当
E-mail infojapan@medicinova.com
URL

https://medicinova.jp/

February 27, 2023
David Bautz, PhD
312-265-9471
dbautz@zacks.com

Zacks Small-Cap Research
Sponsored – Impartial - Comprehensive

Sponsored – Impartial - Comprehensive

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10 S. Riverside Plaza, Chicago, IL 60606

MediciNova, Inc.

(MNOV-NASDAQ)MNOV: Phase 1/2 Clinical Trial of MN-166
in GBM Fully Enrolled…

OUTLOOK

Based on our probability adjusted DCF model that takes into
account potential future revenues from MN-166 in ALS,
progressive MS, addiction, and as an MCM; and MN-001 in
NAFLD, MNOV is valued at $27.00/share. This model ishighly dependent upon continued clinical success of thecompany’s assets and will be adjusted accordingly based
upon future clinical results.

Current Price (02/27/23)
Valuation$2.23$27.00

MediciNova, Inc. (MNOV) recently filed form 10-K withfinancial results for the full year 2022. The company
recently announced that the Phase 1/2 clinical trial MN166 (ibudilast) in combination with temozolomide (TMZ)
in patients with glioblastoma is fully enrolled. Efficacy
data from Part 2 of the trial may be available in thesecond half of 2023. In December 2022, MediciNova
presented positive results from a subgroup analysis ofthe completed Phase 2 clinical trial of MN-001 thatshowed patients with Type 2 diabetes (T2DM) showed
greater improvement in serum lipid profile than those
without T2DM. A trial evaluating MN-001 in patientswith T2DM, non-alcoholic fatty liver disease (NAFLD),
and hypertriglyceridemia is currently ongoing.

SUMMARY DATA
52-Week High
52-Week Low
One-Year Return (%)
Beta
Average Daily Volume (sh)

$3.14
$1.97
-7.47
0.91
15,434

Shares Outstanding (mil)Market Capitalization ($mil)
Short Interest Ratio (days)
Institutional Ownership (%)
Insider Ownership (%)

49$109
N/A2517Annual Cash Dividend
Dividend Yield (%)
5-Yr. Historical Growth Rates
Sales (%)
Earnings Per Share (%)
Dividend (%)$0.000.00

Risk Level
Type of Stock
Industry

Average
Small-Value
Med-Biomed/GeneZACKS ESTIMATES
Revenue(In millions of $)

Q1
(Mar)

Q2(Jun)Q3(Sep)Q4(Dec)Year(Dec)

2022

0A

0A

0A

0A

0A

2023

0E

0E

0E

0E

0E

2024

0E

2025

0E

Earnings per Share
N/A
N/A
N/A

P/E using TTM EPS

N/A

P/E using 2018 Estimate
P/E using 2019 Estimate

N/A
N/A

2022
2023
20242025© Copyright 2023, Zacks Investment Research. All Rights Reserved.

Q1(Mar)Q2(Jun)Q3(Sep)Q4(Dec)Year(Dec)-$0.07 A-$0.08 A-$0.07 A-$0.06 A-$0.29 A-$0.07 E-$0.07 E-$0.08 E-$0.08 E-$0.30 E-$0.32 E-$0.35 E

WHAT’S NEW
Business Update
GBM Trial Fully Enrolled
On January 12, 2023, MediciNova, Inc. (MNOV) announced that the Phase 2 trial of MN-166 (ibudilast) in
combination with temozolomide (TMZ) for the treatment of glioblastoma (GBM) is fully enrolled(NCT03782415). This is a two-part trial taking place at Dana-Farber Cancer Institute; Part 1 of the trial
evaluated the safety and tolerability of MN-166 in combination with TMZ and determined the optimal dose ofMN-166 to use in Part 2 of the study. Part 2 will evaluate the efficacy of MN-166 and TMZ as measured by theproportion of subjects who are progression-free at 6 months. Additional outcome measures will include overall
survival, response rate, and median six-month progression-free survival.
On February 20, 2023, MediciNova announced the presentation of new data regarding tumor tissue analysis
and clinical outcome from Part 1 of the study (the dose ranging portion of the trial). The tumor tissues wereanalyzed to determine potential predictors of tumor response to MN-166 and TMZ combination therapy. Study
participants were divided into two groups: non-responders (disease progression within five months of receiving
MN-166/TMZ) and responders (no disease progression for five months after receiving MN-166/TMZ). The data
showed that responders had a lower percentage of CD3+ T cells than non-responders (P<0.05). In addition,
CD74 expression was also lower in the responders compared to the non-responders (P=0.06). The best
predictor for tumor progression for five months in recurrent GBM patients was CD3 expression.
The use of MN-166 in GBM is based on a proteomic profiling study of GBM samples from 30 GBM patients
which was presented at the 2017 American Society of Clinical Oncology (ASCO) annual meeting (McDonaldet al). The results showed that macrophage migration inhibitory factor (MIF) was expressed in “poorresponders” (e.g., those that lived < 1 year). MIF is an inflammatory-related cytokine that is secreted bycancer stem cells. The researchers then examined an additional 168 GBM samples and found co-expressionof MIF and its receptor CD74 in 57% of the samples. In addition, co-expression of MIF and CD74 wassignificantly associated with poor survival. These results point to MIF being a suitable target for GBM
treatment. MN-166 is an inhibitor of MIF (Cho et al., 2010).
Additional Positive Developments from MN-001 Study in NAFLDIn December 2022, MediciNova announced the presentation of positive results from a subgroup analysis ofthe completed Phase 2 clinical trial of MN-001 (tipelukast) for the treatment of hypertriglyceridemia (HTG). In
the trial, MN-001 significantly reduced serum triglycerides in participants with non-alcoholic fatty liver disease(NAFLD) and HTG. The subgroup analysis examined was conducted in participants with and without type 2
diabetes mellitus (T2DM). The results showed that:•The T2DM group showed a greater reduction in serum triglyceride level at Week 8 compared to those
without T2DM (50.8% reduction for those with T2DM versus 17.8% reduction for those without T2DM,P=0.098).

•Those with T2DM had a mean high-density lipoprotein cholesterol (HDL-C) increase at Week 8 thatwas significantly greater than those without T2DM (15.8% versus 1.0%, P<0.0002).

•The T2DM group showed a greater reduction in serum low-density lipoprotein cholesterol (LDL-C) at
Week 8 compared to those without T2DM (15.4% versus 6.7%).

These results are very encouraging as numerous studies have reported that approximately 50% of patientswith metabolic syndrome also have NAFLD. It also supports the rationale for the company’s ongoing clinical
trial of MN-001 in patients with NAFLD, T2DM, and HTG.

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Long COVID Trial Cleared to Initiate by Health CanadaOn February 8, 2023, MediciNova announced that Health Canada granted authorization to commence
RECLAIM (Recovering from COVID-19 Lingering Symptoms Adaptive Integrative Medicine Trial), which is agrant-funded, multi-center, randomized clinical trial to evaluate MN-166 and other therapies for the treatmentof Long COVID. The University Health Network is conducting the trial, which is being funded by the Canadiangovernment through the Canadian Institutes of Health Research.
This study is an excellent opportunity for MediciNova. Since it is a grant funded study the company will nothave to expend any financial resources other than drug supply. Grant funding is incredibly competitive, thus
the fact that a study involving MN-166 got selected for funding is very encouraging. Lastly, Long COVID could
represent a tremendous opportunity given the number of patients that could be affected by the condition.
Following an infection with SARS-CoV-2, the virus that causes COVID-19, approximately 30% of patients will
experience symptoms that last for weeks or months, which is referred to as Long COVID. The range ofsymptoms varies from patient to patient, however the most commonly reported (from a meta analysis) were
fatigue (58%), headache (44%), attention disorder (27%), hair loss (25%), and dyspnea (24%) (Lopez-Leon etal., 2021). With approximately 200 million individuals already having been infected with SARS-CoV-2 in theU.S., and greater than one billion around the world, there are a very large number of potential Long COVID
patients. There are currently no treatment options available for Long COVID.
New Parenteral Formulation for MN-166
In January 2023, MediciNova announced the completion of a Phase 1 clinical trial to evaluate MN-166 10 mg
intravenous infusion in healthy volunteers. The parenteral formulation had a favorable safety profile and waswell tolerated. In addition, there were no concerning adverse events (AEs), all AEs were mild, all study drugrelated AEs were mild, and none of the AEs were unexpected.
This new formulation will provide health care providers another option for administering MN-166, such as inacute care settings where a patient is unable to take an oral dose, and potentially other indications that require
injections in precise locations. Lastly, a parenteral formulation will allow MN-166 to be evaluated in additionaltarget indications that aren’t currently available with an oral formulation.
Phase 2 Alcohol Use Disorder Trial Fully Enrolled
In January 2023, MediciNova announced that the Phase 2b clinical trial of MN-166 for the treatment of alcohol
use disorder (AUD) has completed enrollment. This is a randomized, double blind, placebo controlled
outpatient clinical trial that enrolled 102 treatment-seeking individuals with moderate or severe AUD(NCT03594435). Participants took MN-166 (50 mg) or placebo twice a day for 12 weeks and completed theNIAAA-developed web-based program Take Control. The primary endpoint of the trial is the decrease inpercent heavy drinking days (defined as ≥5 drinks for men and ≥4 drinks for women) compared to placebo
over the course of the 12-week trial. Secondary endpoints will test the efficacy of MN-166 on: 1) the number ofdrinks consumed per day; 2) the number of drinks consumed per drinking day; 3) the percentage of days
abstinent; 4) the percentage of subjects with no heavy drinking days; and 5) the percentage of subjects whoare abstinent.
This is an NIH sponsored study being conducted by Dr. Lara Ray, who previously conducted two positive
small trials of MN-166 in AUD. MediciNova provided drug supply and regulatory support for the study,
however the company is not expending any financial resources for the trial. Data from the trial is likely later
this year.
Financial Update
On February 16, 2023, MediciNova filed Form 10-K with financial results for the full year 2022. The company
did not report any revenues in 2022 compared to $4.0 million for the year ended December 31, 2021. The
revenue in 2021 was related to the achievement of milestones from an assignment agreement with Genzyme.
Net loss for 2022 was $14.1 million, or $0.29 per share, compared to a net loss of $10.1 million, or $0.21 pershare, for 2021. R&D expenses in 2022 were $9.1 million compared to $8.5 million in 2021. The increase wasZacks Investment ResearchPage 3scr.zacks.com

primarily due to an increase in MN-166 and MN-221 related expenses. G&A expenses in 2022 were $5.5
million compared to $5.7 million in 2021. The decrease was primarily due to decreased non-cash stock-based
compensation partially offset by increased compensation costs and increased accounting expenses.
MediciNova exited 2022 with approximately $58.5 million in cash and investments (bank CDs). We estimate
the company has sufficient capital to fund operations at least through the end of 2024. As of February 13,
2023, the company had approximately 49.0 million shares outstanding and when factoring in stock options afully diluted share count of approximately 57.0 million.
Conclusion
MediciNova has multiple potential catalysts in 2023, including results from chlorine gas-induced acute lunginjury preclinical studies under an agreement with BARDA and topline data for the recently fully enrolled
Phase 1/2 GBM study and the Phase 2b AUD study, although we are unsure of the exact timing of those data
releases. The subgroup analysis for the HTG study of MN-001 is very encouraging and provides solid support
for the company’s decision to focus on patients with T2DM in the ongoing clinical trial of MN-001 in NAFLD,
T2DM, and HTG. We have made no changes to our model and our valuation remains at $27.

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PROJECTED FINANCIALS
MediciNova Inc.
Income Statement

MediciNova, Inc.
MN-166 (Multiple Sclerosis)
MN-166 (ALS)
MN-166 (Addiction)
MN-166 (DCM)
MN-001 (NASH)
Grants & Collaborative Revenue

Total Revenues

2022 A

Q1 E

Q2 E

Q3 E

Q4 E

2023 E2024 E2025 E$0$0$0$0
$0
$0

$0
$0
$0
$0
$0
$0

$0
$0
$0
$0
$0
$0

$0
$0
$0
$0
$0
$0

$0
$0
$0
$0
$0
$0

$0
$0
$0
$0
$0
$0

$0
$0
$0
$0
$0
$0

$0
$0
$0
$0
$0
$0

$0

$0

$0

$0

$0

$0

$0

$0

Cost of Sales

$0

$0

$0

$0

$0

$0

$0

$0

Product Gross Margin-------

-

$9.1
$5.5
$0

$2.2
$1.3
$0

$2.3
$1.4
$0

$2.5
$1.5
$0

$2.6
$1.6
$0

$9.6
$5.8
$0

$10.0
$6.0
$0

$11.0
$6.5
$0

($14.6)($3.5)($3.7)($4.0)($4.2)($15.4)($16.0)($17.5)--------

$0.6

$0.2

$0.2

$0.2

$0.2

$0.8

$0.1

$0.1

Research & Development
General & Administrative
Other Expenses

Operating Income
Operating Margin

Non-Operating Expenses (Net)

Pre-Tax Income($14.1)($3.3)($3.5)($3.8)($4.0)($14.6)($15.9)($17.4)

Income Taxes Paid

$0

$0

$0

$0

$0

$0

$0

$0

Tax Rate

0%0%

0%

0%

0%

0%0%

0%

($14.1)($3.3)($3.5)($3.8)($4.0)($14.6)($15.9)($17.4)Net Income
Net Margin

Reported EPS
YOY Growth

Basic Shares Outstanding
Source: Zacks Investment Research, Inc.

--------($0.29)($0.07)($0.07)($0.08)($0.08)($0.30)($0.32)($0.35)--------

49.04549.05049.05049.05049.05049.05049.20049.500David Bautz, PhD© Copyright 2023, Zacks Investment Research. All Rights Reserved.

HISTORICAL STOCK PRICE

Source: Zacks Small Cap Research© Copyright 2023, Zacks Investment Research. All Rights Reserved.

DISCLOSURESThe following disclosures relate to relationships between Zacks Small-Cap Research (“Zacks SCR”), a division of Zacks Investment Research(“ZIR”), and the issuers covered by the Zacks SCR Analysts in the Small-Cap Universe.
ANALYST DISCLOSURES
I, David Bautz, PhD, hereby certify that the view expressed in this research report accurately reflect my personal views about the subject
securities and issuers. I also certify that no part of my compensation was, is, or will be, directly or indirectly, related to the recommendations orviews expressed in this research report. I believe the information used for the creation of this report has been obtained from sources I considered
to be reliable, but I can neither guarantee nor represent the completeness or accuracy of the information herewith. Such information and theopinions expressed are subject to change without notice.

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Zacks SCR has received compensation from the issuer directly, from an investment manager, or from an investor relations consulting firmengaged by the issuer for providing non-investment banking services to this issuer and expects to receive additional compensation for such noninvestment banking services provided to this issuer. The non-investment banking services provided to the issuer includes the preparation of thisreport, investor relations services, investment software, financial database analysis, organization of non-deal road shows, and attendance fees
for conferences sponsored or co-sponsored by Zacks SCR. The fees for these services vary on a per-client basis and are subject to the numberand types of services contracted. Fees typically range between ten thousand and fifty thousand dollars per annum. Details of fees paid by thisissuer are available upon request.

POLICY DISCLOSURESThis report provides an objective valuation of the issuer today and expected valuations of the issuer at various future dates based on applying
standard investment valuation methodologies to the revenue and EPS forecasts made by the SCR Analyst of the issuer’s business.
SCR Analysts are restricted from holding or trading securities in the issuers that they cover. ZIR and Zacks SCR do not make a market in any
security followed by SCR nor do they act as dealers in these securities. Each Zacks SCR Analyst has full discretion over the valuation of theissuer included in this report based on his or her own due diligence. SCR Analysts are paid based on the number of companies they cover.
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CANADIAN COVERAGE
This research report is a product of Zacks SCR and prepared by a research analyst who is employed by or is a consultant to Zacks SCR. The
research analyst preparing the research report is resident outside of Canada, and is not an associated person of any Canadian registeredadviser and/or dealer. Therefore, the analyst is not subject to supervision by a Canadian registered adviser and/or dealer, and is not required tosatisfy the regulatory licensing requirements of any Canadian provincial securities regulators, the Investment Industry Regulatory Organization of
Canada and is not required to otherwise comply with Canadian rules or regulations.

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