2023 年 10 月 2 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 9 月 29 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/

September 29, 2023
David Bautz, PhD
312-265-9471
dbautz@zacks.com

Zacks Small-Cap Research
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10 S. Riverside Plaza, Chicago, IL 60606

MediciNova, Inc.

(MNOV-NASDAQ)MNOV: Positive Results for MN-166 in
Chlorine Gas-Induced Acute Lung Injury
Model…

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 (09/29/23)
Valuation$2.12$27.00On September 27, 2023, MediciNova, Inc. (MNOV)
announced results of nonclinical studies conductedunder the BARDA contract to develop MN-166(ibudilast) as a medical countermeasure (MCM) for thetreatment of chlorine gas-induced lung injury. The
studies included both a single-dose and multi-dose
evaluation of MN-166 following chlorine gas exposure.
The multi-dose study showed that treatment with highdose MN-166 resulted in greater improvement inPaO2/FiO2 (ratio of arterial oxygen partial pressure to
fractional inspired oxygen) compared to low-dose MN166, the positive control rolipram, and negative control(P=0.0001). The company plans to meet with the FDA
to determine the next steps for the program.

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

$2.66
$1.95
-3.20
0.93
23,797

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

49
$104
N/A
11
17

Annual Cash Dividend
Dividend Yield (%)
5-Yr. Historical Growth Rates
Sales (%)
Earnings Per Share (%)
Dividend (%)

$0.00
0.00

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

0A

0A

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
2024
2025

© 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-$0.06 A-$0.06 A-$0.08 E-$0.08 E-$0.28 E-$0.32 E-$0.35 E

WHAT’S NEW
Business Update
Positive Results for MN-166 in Nonclinical Model of Chlorine Gas-Induced Lung Injury
On September 27, 2023, MediciNova, Inc. (MNOV) announced results from the nonclinical studies conductedunder its contract with the Biomedical Advanced Research and Development Authority (BARDA) to develop
MN-166 (ibudilast) as a potential medical countermeasure (MCM) against chlorine gas (Cl2)-induced lungdamage such as acute respiratory distress syndrome (ARDS) and acute lung injury (ALI).
The primary objective of the study was to determine the safety and pharmacological activity of MN-166
following ALI induced by Cl2 gas inhalation. Both single- and multi-dose treatments were evaluated. The
primary endpoint of the study was pulmonary function as measured by PaO2/FiO2, the ratio of arterial oxygen
partial pressure to fractional inspired oxygen. ARDS is defined as a PaO2/FiO2 ratio < 300 mmHg while
moderate ALI is defined as a mean PaO2/FiO2 < 200 mmHg.
Following Cl2 gas-induced moderate ALI, the animals were divided into four different treatment groups: twodoses of MN-166 (high dose or low dose), a positive control (rolipram), and a negative control. Treatments
were given intravenously (IV) over 30 minutes. In the single-dose treatment study the animals were treated
only once following the Cl2 gas challenge while in the multi-dose study they were treated every 12 hours for a
total of four doses following Cl2 gas challenge.
The results of the single-dose study showed that MN-166 high dose and the positive control were more
efficacious than MN-166 low dose and the negative control until 12 hours after Cl2 exposure. However, there
was not a statistically significant difference in overall pulmonary function. MN-166 was well tolerated and there
were no safety concerns observed.
In the multi-dose trial, treatment with MN-166 high dose resulted in a statistically significant improvement in
the mean PaO2/FiO2 ratio when compared to MN-166 low dose, rolipram, and the negative control (P=0.0001).
The following table shows the PaO2/FiO2 ratio at baseline and 48 hours after Cl2 gas exposure for the negative
control group and the high-dose MN-166 group.

The PaO2/FiO2 ratio was 46% higher (a higher value is better) in the high dose MN-166 group than in thenegative control group. In addition, since ARDS is defined as a PaO2/FiO2 ratio < 300 mmHg, the values at 48
hours indicate that the negative control group was still categorized as having mild ARDS but the high dose
MN-166 group had recovered sufficiently to no longer be defined as having ARDS. MN-166 was well tolerated
and there were no safety concerns observed.
The BARDA contract had called for two different animal models of Cl2 gas induced lung injury to be evaluated,
however MediciNova’s subcontractor was unable to establish the feasibility of a second model and thus there
were no evaluable efficacy results obtained from that second model.
Background on ARDS
ARDS is a serious lung disorder that results from the small blood vessels of the lung leaking fluid that fills up
the alveoli, thus preventing proper oxygen exchange (Stevens et al., 2018). There are many causes of ARDS,
including infections (e.g., pneumonia), severe burns, pancreatitis, inhalation of smoke or chemicals, or other

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serious illnesses. An excessive inflammatory response appears to be involved in the pathogenesis of ARDS
(Li et al., 2019). Current treatment options involve supportive care while the lungs heal, which involves oxygentherapy supplied through a ventilator. There are no pharmacological treatments specifically for ARDS andapproximately 40% of hospitalized patients die from it (Siegel et al., 2020).
According to the NIH, infections are the most common risk factors for ARDS (NIH). The most common
infections are due to influenza (and other respiratory viruses), pneumonia, and sepsis. There areapproximately one million adults hospitalized in the U.S. each year for pneumonia (ATS), approximately
400,000 hospitalizations due to influenza each year in the U.S. (CDC), and approximately 1 million
hospitalizations due to sepsis (UMich). While not all of these patients will go on to develop ARDS, it is thispool of patients that are at a high-risk of developing ARDS that will be the target market for MediciNova.
The release of toxic chemicals, either deliberately through chemical weapons or accidentally through an
industrial accident, can also result in ALI or ARDS. Chlorine is a widely used industrial chemical (e.g., water
purification) that has been previously implicated in both intentional and accidental releases:•

During World War I, Germany launched the first known chemical weapon attack by releasing chlorine
gas from 6,000 cylinders against French troops, which caused >1,000 casualties.

•

Multiple times in the past decade, the Syrian government of Bashar al-Assad used chlorine as achemical weapon against its enemies, and a report by the U.S. government in 2020 claimed theregime continues to pursue chemical weapons development.

•

In June 2005, a train derailment in South Carolina resulted in the accidental release of 40-60 tons ofchlorine gas (Van Sickle et al., 2009). Nine individuals died and >250 were treated for toxic chlorine
exposure.

•

A mixture of sodium hypochlorite and hydrochloric acid is sometimes used as a cleaning solution. The
chlorine gas that is produced can cause airway damage and reactive airways dysfunction syndrome(RADS) (Gorguner et al., 2004).

Chlorine inhalation results in the formation of hydrochloric acid (HCl) and hypochlorous acid (HOCl) as it
dissolves into the airway surface liquid. Both of those compounds can result in oxidative injury following theformation of reactive oxygen species, which can result in edema, inflammation, and immediate airway
constriction. In addition, chlorine exposure results in the recruitment of inflammatory neutrophils andmacrophages (Balakrishna et al., 2014). The inflammatory response is accompanied by increases in various
inflammatory markers such as CXCL1, GM-CSF, IL-6, and VEGF.
Current treatment for chlorine inhalation is mostly supportive care. For patients who show airway obstruction,
inhaled -2-adrenergic agonists are used (Wang et al., 2004) with early administration of corticosteroids
shown to prevent ALI in mouse models (Jonasson et al., 2013). Humidified oxygen is typically administered toall victims, however supplemental oxygen could worsen cardiopulmonary function (Okponyia et al., 2018).
The Department of Homeland Security estimates that a deliberate release of highly concentrated chlorine gas
upwind of an urban area with 700,000 individuals would lead to approximately 5% being exposed to a lethal
dose of chlorine with approximately 17,500 fatalities and 100,000 hospitalizations (Department of Homeland
Security). Chlorine gas is fairly easy to produce, thus the U.S. government is interested in finding MCMs totreat lung injuries caused by chlorine exposure.
The potential market opportunity for MN-166 in chlorine gas-induced ALI is significant as the U.S. government
would likely decide to purchase large quantities of the drug for public health emergencies in the homeland(Strategic National Stockpile) and to protect U.S. military personnel abroad.
In addition, drugs approved as MCMs are eligible for a priority review voucher (PRV). A PRV allows the holderof the voucher to receive an expedited six-month review from the FDA for a new drug application (NDA) or
biologics license application (BLA) instead of the usual ten-month review. PRVs are fully transferrable and in
the past couple of years a number of them have sold for approximately $100 million each.

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MN-166 was previously tested in a lipopolysaccharide (LPS) ARDS mouse model (Yang et al., 2020). While
this model induces ARDS through a different mechanism than chlorine gas exposure, a number of theresulting phenotypes are similar between the two models. MN-166 was shown to reduce the overexpression of
PDE4, reduce the overexpression of different inflammatory cytokines (e.g., TNF-, IL-1b, IL-6, MCP-1),
reduce pulmonary edema, and reduce lung cell apoptosis. Since ARDS can be induced by a number ofdifferent pathologic insults, success in one model system (e.g., LPS-induced ARDS) is likely to translate tosuccess in other models (e.g., chlorine gas-induced ARDS).
In June 2022, MediciNova announced positive results from a Phase 2 clinical trial of MN-166 (ibudilast) in
hospitalized COVID-19 patients at risk for developing ARDS. The trial achieved statistical significance for oneof the co-primary endpoints (the proportion of subjects free of respiratory failure), and achieved statisticalsignificance for the proportion of subjects discharged from the hospital. A total of 34 subjects were randomized
1:1 to receive MN-166 or placebo for seven days, and on Day 7, 71% of subjects in the MN-166 group and
35% of the placebo group were free of respiratory failure (P=0.02).
Conclusion
The positive results from the Cl2 gas-induced lung injury model evaluating MN-166 as an MCM are very
encouraging and we look forward to updates from the company on next steps for the program, which will likely
occur after meeting with the FDA. Development of MN-166 as an MCM would not require efficacy trials inhumans, thus it could represent a faster path to approval for the drug along with the potential for a PRV. We
have increased the probability of MN-166 being approved as an MCM, which has slightly increased ourvaluation to $27 per share.

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PROJECTED FINANCIALS
MediciNova Inc.
Income Statement

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

Total Revenues

2022 A

Q1 A

Q2 A

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

Cost of Sales

$0

$0

$0

$0

$0

$0

$0

$0

Product Gross Margin

-

-

-

-

-

-

-

-

$9.1
$5.5
$0

$1.5
$1.5
$0

$1.7
$1.6
$0

$2.5
$1.5
$0

$2.6
$1.6
$0

$8.3
$6.2
$0

$10.0
$6.0
$0

$11.0
$6.5
$0

($14.6)($3.0)($3.3)($4.0)($4.2)($14.5)($16.0)($17.5)

-

-

-

-

-

-

-

-

$0.6

$0.0

$0.4

$0.2

$0.2

$0.9

$0.1

$0.1

Research & Development
General & Administrative
Other Expenses

Operating Income
Operating Margin

Non-Operating Expenses (Net)

Pre-Tax Income($14.1)($2.9)($2.9)($3.8)($4.0)($13.6)($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)($2.9)($2.9)($3.8)($4.0)($13.6)($15.9)($17.4)Net Income
Net Margin

Reported EPS
YOY Growth

Basic Shares Outstanding
Source: Zacks Investment Research, Inc.

-

-

-

-

-

-

-

-

($0.29)($0.06)($0.06)($0.08)($0.08)($0.28)($0.32)($0.35)

-

-

-

-

-

-

-

-

49.04549.04649.04649.05049.05049.04849.20049.500David 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.
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securities and issuers. I also certify that no part of my compensation was, is, or will be, directly or indirectly, related to the recommendations or
views expressed in this research report. I believe the information used for the creation of this report has been obtained from sources I considered
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