Message from the CEO to MediciNova Shareholders

Rhea-AI Summary

MediciNova (MNOV) reported a peer-reviewed publication showing MN-002, the primary metabolite of MN-001, increases cholesterol efflux by upregulating ABCA1 and ABCG1 in macrophages, a mechanism tied to Reverse Cholesterol Transport.

The company completed patient enrollment in its Phase 2 MN-001-NATG-202 randomized, double-blind, placebo-controlled trial in hypertriglyceridemia and NAFLD due to T2DM; top-line results are expected by summer 2026. Management says the mechanistic data reinforce prior clinical lipid-profile observations and will inform next steps toward advancing MN-001 as a potential first-in-class therapy for metabolic and cardiovascular disease.

Positive

• Peer-reviewed publication confirming MN-002 mechanism on ABCA1/ABCG1
• Completed Phase 2 enrollment in MN-001-NATG-202
• Top-line results timing set for summer 2026

Negative

• No top-line efficacy data yet; results pending summer 2026

News Market Reaction

-2.76%

2 alerts

-2.76% News Effect

+2.7% Peak Tracked

-$2M Valuation Impact

$73M Market Cap

0.2x Rel. Volume

On the day this news was published, MNOV declined 2.76%, reflecting a moderate negative market reaction. Argus tracked a peak move of +2.7% during that session. Our momentum scanner triggered 2 alerts that day, indicating moderate trading interest and price volatility. This price movement removed approximately $2M from the company's valuation, bringing the market cap to $73M at that time.

Data tracked by StockTitan Argus on the day of publication.

Key Figures

Q3 2025 revenue: $123,319 Q3 2025 net loss: $3,050,373 Cash & equivalents: $32,562,612 +4 more

7 metrics

Q3 2025 revenue $123,319 Service revenue under Mayo ALS research agreement

Q3 2025 net loss $3,050,373 Net loss, or $0.06 per share, per 10-Q

Cash & equivalents $32,562,612 Balance as of Q3 2025; management cites runway through Nov 2026

SEPA capacity $30.0 million Standby Equity Purchase Agreement with Yorkville

ATM program $75.0 million At-the-market equity facility, no shares sold year-to-date

Authorized shares 100,000,000 Common stock authorized as of Q2 2025

Shares outstanding 49,046,246 Common shares issued and outstanding as of Nov 10, 2025

Market Reality Check

Price: $1.60 Vol: Volume 43,013 is 0.36x th...

low vol

$1.60 Last Close

Volume Volume 43,013 is 0.36x the 20-day average of 120,645, indicating subdued trading. low

Technical Price $1.51 is trading above the 200-day MA $1.38 but remains 36.29% below the 52-week high.

Peers on Argus

MNOV was down 1.95% with light volume, while key biotech peers showed mixed move...

1 Down

MNOV was down 1.95% with light volume, while key biotech peers showed mixed moves, including QNTM at -4.74% and ANL at +4.92%. Momentum data flagged only one peer (VTVT, -6.36%), suggesting stock-specific trading rather than a broad sector trend.

Common Catalyst Peer headlines focused on litigation (QNTM lawsuit coverage), unrelated to MNOV’s mechanistic and clinical update.

Historical Context

5 past events · Latest: Dec 08 (Positive)

Pattern 5 events

Date	Event	Sentiment	Move	Catalyst
Dec 08	ALS trial update	Positive	-3.2%	COMBAT-ALS Phase 2b/3 enrollment, baseline metrics and design update.
Dec 01	Mechanistic & trial	Positive	-2.8%	MN-002 mechanistic data and completed Phase 2 enrollment in MN-001-NATG-202.
Nov 18	Leadership change	Positive	+2.1%	Appointment of Dr. Christopher Breder as Clinical and Regulatory Advisor.
Nov 06	Industry award	Positive	-7.3%	Biotech Breakthrough award recognizing MN-166 development efforts.
Nov 04	Trial enrollment	Positive	-5.3%	Completion of patient enrollment in Phase 2 MN-001-NATG-202 trial.

Pattern Detected

Recent MNOV news has often been followed by negative price reactions even on seemingly positive operational or clinical updates, with only one of the last five events showing a positive next-day move.

Recent Company History

Over the last few months, MediciNova has highlighted steady clinical and corporate progress. Enrollment completed in the MN-001-NATG-202 Phase 2 trial and mechanistic data on MN-002 supported MN-001’s metabolic and cardiovascular potential, yet shares fell after both updates. The company also won a biotech innovation award and provided detailed COMBAT-ALS Phase 2b/3 trial enrollment characteristics for MN-166, but those events likewise saw negative price reactions. Only the appointment of a new Clinical and Regulatory Advisor on Nov 18, 2025 coincided with a positive move, underscoring a pattern of cautious market response to progress news.

Market Pulse Summary

This announcement links a new mechanistic publication for MN-002 with completed enrollment in the Ph...

Analysis

This announcement links a new mechanistic publication for MN-002 with completed enrollment in the Phase 2 MN-001-NATG-202 trial, strengthening the scientific rationale behind MN-001 in metabolic and cardiovascular indications. Recent history shows the stock often reacted cautiously to positive updates, including trial milestones and awards. Against a backdrop of $32.56M in cash and access to a $30.0M SEPA and $75.0M ATM, investors may watch for 2026 top-line data, regulatory interactions, and use of equity facilities as key future markers.

Key Terms

cholesterol efflux, macrophages, abca1, abcg1, +4 more

8 terms

cholesterol efflux medical

"MN-002, the primary metabolite of MN-001, enhances cholesterol efflux in macrophages"

Cholesterol efflux is the process by which cells unload excess cholesterol onto carrier particles, such as HDL (“good” cholesterol), which then transport it to the liver for removal. Investors care because the efficiency of this cleanup system is linked to cardiovascular risk and is used as a biomarker and therapeutic target in drug development; improving efflux can signal lower long‑term costs from heart disease and greater commercial potential for related treatments.

macrophages medical

"enhances cholesterol efflux in macrophages through upregulation of ABCA1 and ABCG1"

Large immune cells that act like the body's garbage collectors and first responders, swallowing germs, dead cells and unwanted material, and coordinating inflammation and tissue repair. They matter to investors because many drugs, diagnostics and medical devices aim to change how these cells behave; success or failure in modifying macrophages can strongly influence a therapy's effectiveness, safety profile, regulatory approval and market potential.

abca1 medical

"through upregulation of ABCA1 and ABCG1 transporters"

ABCA1 is a protein that helps move excess cholesterol out of cells and assembles it into high-density lipoprotein (HDL), the “good” cholesterol that travels to the liver for clearance. Think of it as a cellular garbage truck that loads and sends cholesterol away. Investors care because drugs or diagnostics that affect ABCA1 function can change cardiovascular risk, influence clinical trial outcomes, regulatory decisions, and the commercial value of therapies targeting cholesterol-related diseases.

abcg1 medical

"through upregulation of ABCA1 and ABCG1 transporters"

ABCG1 is a human gene that makes a membrane protein helping cells remove excess cholesterol and other fats, acting like a cellular recycling pump that hands unwanted material to carriers that take it away. For investors, changes in ABCG1 activity can influence risk and treatment strategies for heart disease, metabolic disorders, and related drug development, so findings about ABCG1 can affect valuations and regulatory outlooks for biotech and pharmaceutical firms.

reverse cholesterol transport medical

"the first step in Reverse Cholesterol Transport (RCT)—the body’s natural process"

Reverse cholesterol transport is the body's process of collecting excess cholesterol from arteries and tissues and carrying it back to the liver for disposal, like street sweepers picking up trash and hauling it to a landfill. Investors care because this pathway is a major focus of drugs and diagnostics aimed at reducing heart disease risk; advances or setbacks can change a company’s sales prospects, regulatory outlook, and valuation.

hypertriglyceridemia medical

"address multiple interconnected metabolic disorders—hypertriglyceridemia, non-alcoholic fatty liver disease"

An unusually high level of triglycerides — a type of fat carried in the bloodstream — that signals an increased risk of heart disease and related health problems. For investors, it matters because the size of the patient population, effectiveness of treatments, regulatory approvals, and insurance coverage can drive demand, clinical-trial outcomes, and revenue for drugmakers and medical-device companies; think of it like too much oil in an engine increasing the need for maintenance and repairs.

non-alcoholic fatty liver disease medical

"hypertriglyceridemia, non-alcoholic fatty liver disease (NAFLD), and type 2 diabetes"

Non-alcoholic fatty liver disease is a condition where excess fat builds up in the liver of people who drink little or no alcohol; the liver can become inflamed and scarred over time, reducing its ability to function. Investors should care because its large and growing patient population drives demand for diagnostics, treatments, monitoring tools and healthcare services—think of it like a slowly spreading problem in a factory that creates ongoing repair and replacement business opportunities across pharmaceuticals, medical devices, and insurers.

type 2 diabetes medical

"non-alcoholic fatty liver disease (NAFLD), and type 2 diabetes (T2DM)"

Type 2 diabetes is a chronic condition where the body struggles to control blood sugar levels because it becomes less responsive to insulin, a hormone that helps regulate sugar in the blood. It matters to investors because it can lead to increased healthcare costs, affect workforce productivity, and influence the performance of companies in the healthcare and pharmaceutical sectors. Managing or preventing the condition has significant implications for public health and economic stability.

AI-generated analysis. Not financial advice.

Strengthening MN-001’s Scientific Foundation and Clinical Outlook

LA JOLLA, Calif., Dec. 01, 2025 (GLOBE NEWSWIRE) --

Dear Fellow Shareholders,

Following the recent publication in the Journal of Atherosclerosis and Thrombosis, I would like to provide additional perspective on why this research represents a significant milestone for MediciNova and our MN-001 program. The study, conducted in collaboration with a leading Japanese academic research team, revealed a novel mechanism by MN-002, the primary metabolite of MN-001, enhances cholesterol efflux in macrophages through upregulation of ABCA1 and ABCG1 transporters. This mechanism is critical because cholesterol efflux is the first step in Reverse Cholesterol Transport (RCT)—the body’s natural process for clearing cholesterol from arterial walls, a key driver of atherosclerosis and cardiovascular disease.

Why This Matters for Our Strategy
This mechanistic insight provides strong scientific validation for the lipid profile improvements observed in prior MN-001 clinical studies. It also reinforces MN-001’s potential to address multiple interconnected metabolic disorders—hypertriglyceridemia, non-alcoholic fatty liver disease (NAFLD), and type 2 diabetes (T2DM)—conditions that share underlying pathologies of lipid dysregulation and chronic inflammation. MN-001’s multi-modal activity, including anti-inflammatory and anti-fibrotic properties, positions it uniquely among emerging therapies.

Clinical Progress and Next Steps
We have completed patient enrollment in our Phase 2 trial (MN-001-NATG-202) in patients with hypertriglyceridemia and NAFLD due to T2DM. This is the first randomized, double-blind, placebo-controlled study to evaluate the efficacy of MN-001 in Hypertriglyceridemia and NAFLD due to T2DM. Top-line results are expected by summer 2026. These data, combined with the newly published mechanistic findings, will inform our next steps toward advancing MN-001 as a potential first-in-class therapy for metabolic and cardiovascular disease.

This is an exciting time for MediciNova. We remain committed to translating these scientific advances into meaningful clinical outcomes and creating long-term value for our shareholders.

Thank you for your continued support.

Yuichi Iwaki, M.D., Ph.D.
President and Chief Executive Officer

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-001 (tipelukast) is in a Phase 2 trial treating hypertriglycedemia in type 2 diabetic patients. MediciNova has a strong track record of securing investigator-sponsored clinical trials funded through government grants.

Forward-Looking Statements
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, 2024 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

FAQ

What did MediciNova announce about MN-001/MN-002 mechanism for MNOV on December 1, 2025?

MediciNova said a Journal of Atherosclerosis and Thrombosis paper showed MN-002 enhances cholesterol efflux via upregulation of ABCA1 and ABCG1 in macrophages.

What is the status of MediciNova's Phase 2 MN-001-NATG-202 trial (MNOV)?

The company reported patient enrollment is complete for MN-001-NATG-202, a randomized, double-blind, placebo-controlled Phase 2 trial.

When does MediciNova expect top-line results for MN-001 (MNOV)?

MediciNova expects top-line Phase 2 results by summer 2026.

How might the MN-002 mechanistic finding affect MN-001's development for MNOV shareholders?

The company says the mechanistic data validate prior lipid-profile improvements and will inform development toward a potential first-in-class metabolic and cardiovascular therapy.

Does the December 1, 2025 message include financial guidance for MNOV shareholders?

No; the message focuses on scientific findings and clinical progress and does not provide financial guidance or numeric forecasts.