Medicinova (MNOV)
MediciNova, Inc. is a publicly-traded biopharmaceutical company founded upon developing novel, small-molecule therapeutics for the treatment of diseases with unmet medical needs with a primary commercial focus on the U.S. market. MediciNova's current strategy is to focus on MN-166 (ibudilast) for neurological disorders such as progressive multiple sclerosis (MS), amyotrophic lateral sclerosis (ALS), degenerative cervical myelopathy (DCM), substance dependence (e.g., alcohol use disorder, methamphetamine dependence, opioid dependence) and glioblastoma (GBM), as well as prevention of acute respiratory distress syndrome (ARDS) caused by COVID-19, and MN-001 (tipelukast) for fibrotic diseases such as nonalcoholic steatohepatitis (NASH) and idiopathic pulmonary fibrosis (IPF). MediciNova's pipeline also includes MN-221 (bedoradrine) and MN-029 (denibulin).

Company profile
Ticker
MNOV
Exchange
Website
CEO
Yuichi Iwaki
Employees
Incorporated
Location
Fiscal year end
Industry (SIC)
SEC CIK
Corporate docs
IRS number
330927979
MNOV stock data
News
MNOV: Genzyme Patent Litigation Could Lead to Significant Payout…
11 Apr 22
MediciNova Announces Plans For A Phase 2 Trial Of MN-001 In NAFLD With Type 2 Diabetes Mellitus And Hypertriglyceridemia
11 Apr 22
MediciNova's Alcohol Use Disorder Candidate Reduces Alcohol Craving, Odds Of Heavy Drinking
8 Apr 22
MediciNova Receives Notice Of Allowance For New Patent Covering MN-001 And MN-002 For The Treatment Of Advanced NASH In Korea
17 Mar 22
MNOV: Ibudilast Identified as Promising Development Candidate in Alcohol Use Disorder and Degenerative Cervical Myelopathy…
1 Mar 22
Press releases
MediciNova to Participate in the B. Riley Neuro & Ophthalmology Conference
21 Apr 22
MediciNova Announces Publication of MN-166 (ibudilast) Data regarding Prevention of Metastasis in Uveal Melanoma in Molecular Cancer Research
20 Apr 22
MediciNova Announces Completion of Enrollment in the Phase 2 Clinical Trial of MN-166 (ibudilast) in Hospitalized COVID-19 Patients at Risk for Acute Respiratory Distress Syndrome
12 Apr 22
MediciNova Announces Plans for a Phase 2 Trial of MN-001 (tipelukast) in NAFLD with Type 2 Diabetes Mellitus and Hypertriglyceridemia
11 Apr 22
MediciNova Announces Secondary Analysis of Phase 2 Trial of MN-166 (ibudilast) in Alcohol Use Disorder Published in Alcoholism: Clinical and Experimental Research
7 Apr 22
Calendar
12 May 22
17 May 22
31 Dec 22
Financial summary
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Cash burn rate (est.) | Burn method: Change in cash | Burn method: Operating income | Burn method: FCF (opex + capex) | Last Q | Avg 4Q | Last Q | Avg 4Q | Last Q | Avg 4Q |
---|---|---|---|---|---|---|
Cash on hand (at last report) | 67.7M | 67.7M | 67.7M | 67.7M | 67.7M | 67.7M |
Cash burn (monthly) | 1.25M | 717.22K | 1.14M | 1.12M | 1.24M | 771.34K |
Cash used (since last report) | 1.94M | 1.12M | 1.77M | 1.74M | 1.93M | 1.2M |
Cash remaining | 65.76M | 66.58M | 65.93M | 65.96M | 65.76M | 66.5M |
Runway (months of cash) | 52.8 | 92.8 | 58.0 | 59.0 | 52.9 | 86.2 |
Recent insider trades
Date | Owner | Security | Transaction | Code | Indirect | 10b5-1 | $Price | #Shares | $Value | #Remaining |
---|---|---|---|---|---|---|---|---|---|---|
27 Jan 22 | Geoffrey OBrien | Employee Stock Option Common Stock | Grant | Acquire A | No | No | 5.92 | 99,000 | 586.08K | 99,000 |
27 Jan 22 | Matsuda Kazuko | Employee Stock Option Common Stock | Grant | Acquire A | No | No | 5.92 | 192,500 | 1.14M | 192,500 |
27 Jan 22 | Iwaki Yuichi | Employee Stock Option Common Stock | Grant | Acquire A | No | No | 5.92 | 302,500 | 1.79M | 302,500 |
23 Aug 21 | Matsuda Kazuko | Common Stock | Option exercise | Acquire M | No | No | 2.3 | 60,000 | 138K | 322,996 |
23 Aug 21 | Matsuda Kazuko | Employee Stock Option Common Stock | Option exercise | Dispose M | No | No | 2.3 | 60,000 | 138K | 0 |
Institutional ownership, Q4 2021
26.8% owned by funds/institutions
13F holders | Current |
---|---|
Total holders | 44 |
Opened positions | 9 |
Closed positions | 5 |
Increased positions | 15 |
Reduced positions | 10 |
13F shares | Current |
---|---|
Total value | 54.75M |
Total shares | 13.14M |
Total puts | 0 |
Total calls | 19.8K |
Total put/call ratio | – |
Largest owners | Shares | Value |
---|---|---|
3D Investment Partners Pte. | 5.5M | $30.65M |
Vanguard | 1.84M | $4.92M |
Essex Woodlands Management | 1.11M | $2.96M |
BLK Blackrock | 731.89K | $1.96M |
Geode Capital Management | 450.67K | $1.21M |
C Citigroup | 447.96K | $1.2M |
Millennium Management | 391.22K | $1.05M |
JPM JPMorgan Chase & Co. | 301.17K | $807K |
Susquehanna International | 276.28K | $740K |
Bridgeway Capital Management | 220.15K | $590K |
Financial report summary
?Competition
Bristol-Myers Squibb • Pfizer • AMGEN • Celgene • Regeneron Pharmaceuticals • Ionis Pharmaceuticals • Alkermes • Biogen • Incyte • Gilead SciencesRisks
- If we fail to obtain the capital necessary to fund our operations, we will be unable to develop and commercialize our product candidates.
- We do not have any products that are approved for commercial sale and therefore do not expect to generate any revenues from product sales in the foreseeable future, if ever.
- Because the results of early clinical trials are not necessarily predictive of future results, our product candidates we advance into clinical trials in any indication may not have favorable results in later clinical trials, if any, or receive regulatory approval.
- Our attempts to develop MN-001 (tipelukast) in NASH and IPF may detract from our efforts to develop other product candidates and may limit the effectiveness of our product development efforts as a whole.
- In order to commercialize a therapeutic drug successfully, a product candidate must receive regulatory approval after the successful completion of clinical trials, which are long, complex and costly, have a high risk of failure and can be delayed or terminated at any time.
- We are subject to stringent regulation of our product candidates, which could delay the development and commercialization of our product candidates.
- Even if our product candidates receive regulatory approval, they may still face future development and regulatory difficulties.
- Any product candidates that we advance into clinical trials may cause undesirable side effects or have other properties that could delay or prevent regulatory approval or commercialization or limit its commercial potential.
- Delays in the commencement or completion of clinical trials, or suspension or termination of our clinical trials, could result in increased costs to us and delay or limit our ability to obtain regulatory approval for our product candidates.
- The loss of any rights to develop and market any of our product candidates could significantly harm our business.
- We rely on third parties to conduct our clinical trials, and we may incur additional development costs, experience delays in the commencement and completion of clinical trials, and be unable to obtain regulatory approval for or commercialize our product candidates on our anticipated timeline if these third parties do not successfully carry out their contractual duties or meet expected deadlines.
- We rely on third party manufacturers to produce our product candidates, which may result in delays in our clinical trials and the commercialization of products, as well as increased costs.
- We may not be able to manufacture our product candidates in commercial quantities, which would prevent us from commercializing our product candidates.
- Our product candidates, if approved for sale, may not gain acceptance among physicians, patients and the medical community, thereby limiting our potential to generate revenues.
- If our products are not accepted by the market or if users of our products are unable to obtain adequate coverage of and reimbursement for our products from government and other third party payers, our revenues and profitability will suffer.
- We are dependent on our management team, particularly our President and Chief Executive Officer, and our experienced scientific staff, and if we are unable to retain, motivate and attract key personnel, our product development programs may be delayed and we may be unable to develop successfully or commercialize our product candidates.
- If we are unable to establish sales, marketing and distribution capabilities, whether independently or with third parties, we will be unable to commercialize our product candidates successfully.
- Health care reform measures could adversely affect our business.
- We may be sued for product liability, which could result in substantial liabilities that exceed our available resources and damage our reputation.
- We expect that our results of operations will fluctuate, which may make it difficult to predict our future performance from period to period.
- We will continue to incur significant increased costs as a result of operating as a public company, and our management will be required to devote substantial time to new compliance initiatives.
- We may be subject to information technology systems failures, network disruptions, breaches in data security and computer crime and cyber-attacks.
- Our ability to compete may decline if we do not adequately protect our proprietary rights.
- Confidentiality agreements with employees and others may not adequately prevent disclosure of our trade secrets and other proprietary information and may not adequately protect our intellectual property, which could limit our ability to compete.
- A dispute concerning the infringement or misappropriation of our proprietary rights or the proprietary rights of others could be time consuming and costly, and an unfavorable outcome could harm our business.
- We may be subject to claims that our employees have wrongfully used or disclosed alleged trade secrets of their former employers.
- Our stock price may be volatile, and you may not be able to resell our shares at a profit or at all.
- Our common stock may be delisted on the NASDAQ Global Market or the JASDAQ Market of the Tokyo Stock Exchange.
- The sale of additional common stock under our existing at-the-market issuance sales agreement may cause substantial dilution to our existing stockholders and/or the price of our common stock to decline.
- We may become involved in securities class action litigation that could divert management’s attention and harm our business.
- Future sales of our common stock may cause our stock price to decline and may make it difficult for us to raise additional capital or for you to sell your shares.
- Anti-takeover provisions in our charter documents and under Delaware law may make an acquisition of us more complicated and the removal and replacement of our directors and management more difficult.
Management Discussion
- Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations
- We are a biopharmaceutical company focused on developing novel, therapeutics for the treatment of serious diseases with unmet medical needs and a commercial focus on the United States market. Our current strategy is to focus our development activities on MN-166 (ibudilast) for neurological and other disorders such as progressive multiple sclerosis (MS), amyotrophic lateral sclerosis (ALS), chemotherapy-induced peripheral neuropathy, degenerative cervical myelopathy, glioblastoma, substance dependence and addiction (e.g., methamphetamine dependence, opioid dependence, and alcohol dependence), and prevention of acute respiratory distress syndrome (ARDS), and MN-001 (tipelukast) for fibrotic diseases such as nonalcoholic steatohepatitis (NASH) and idiopathic pulmonary fibrosis (IPF). Our pipeline also includes MN-221 (bedoradrine) for the treatment of acute exacerbation of asthma and MN-029 (denibulin) for solid tumor cancers. We were incorporated in Delaware in September 2000.
- We have incurred significant net losses since our inception. For the year ended December 31, 2021, we had a net loss of $10.1 million. At December 31, 2021, from inception, our accumulated deficit was $393.1 million. We expect to incur substantial net losses for the next several years as we continue to develop certain of our existing product development programs, and over the long-term if we expand our research and development programs and acquire or in-license products, technologies or businesses that are complementary to our own.
Content analysis
?Positive | ||
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H.S. freshman Avg
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New words:
adjusted, analogized, ASC, attention, aware, brought, case, certainty, Codification, committee, component, comprehensive, divert, Europe, exclusivity, expended, fatty, functional, GmbH, ill, liver, local, minimum, molecule, NAFLD, payable, reduction, running, scope, small, translation, ultimately, unable
Removed:
allocated, amending, bearing, clarifying, consistent, contractual, curve, decreased, default, derivative, derive, earn, enrolled, exposed, exposure, facilitating, financially, fluctuating, health, higher, hypothetical, interest, invested, investing, investment, involving, manage, mitigate, move, NeuroNEXT, NIH, occasionally, ongoing, Phase, portfolio, post, posted, preserve, primary, principal, proportional, purpose, referred, relationship, removing, Secondary, sensitive, simplification, Simplifying, structured, supply, traded, unconsolidated, variable, Web, yield
Financial reports
Current reports
8-K
Other Events
4 Apr 22
8-K
Departure of Directors or Certain Officers
2 Aug 21
8-K
Entry into a Material Definitive Agreement
23 Jul 21
8-K
Submission of Matters to a Vote of Security Holders
17 Jun 21
8-K
Other Events
18 May 21
8-K
Other Events
5 May 21
8-K
MediciNova Announces Closing of US$20 Million Private Placement Transaction
1 Feb 21
8-K
MediciNova Enters into US$20 Million Securities Purchase Agreement with a fund
12 Jan 21
8-K
MediciNova Appoints Carolyn Beaver to its Board of Directors and as Audit Committee Chair
21 Oct 20
8-K
Departure of Directors or Certain Officers
21 Jun 20
Registration and prospectus
S-8
Registration of securities for employees
13 May 22
424B3
Prospectus supplement
12 Feb 21
424B5
Prospectus supplement for primary offering
23 Aug 19
S-8
Registration of securities for employees
21 Jun 19
424B5
Prospectus supplement for primary offering
7 Feb 18
424B5
Prospectus supplement for primary offering
6 Feb 18
S-3
Shelf registration
21 Sep 17
S-8
Registration of securities for employees
25 Jul 17
Proxies
DEFA14A
Additional proxy soliciting materials
26 Apr 22
DEFA14A
Additional proxy soliciting materials
27 Apr 21
DEFA14A
Additional proxy soliciting materials
27 Apr 20
DEFA14A
Additional proxy soliciting materials
1 May 19
DEFA14A
Additional proxy soliciting materials
9 May 18
DEF 14A
Definitive proxy
25 Apr 18
Other
EFFECT
Notice of effectiveness
11 Feb 21
CORRESP
Correspondence with SEC
7 Feb 21
UPLOAD
Letter from SEC
4 Feb 21
EFFECT
Notice of effectiveness
23 Aug 19
CORRESP
Correspondence with SEC
19 Aug 19
UPLOAD
Letter from SEC
13 Aug 19
UPLOAD
Letter from SEC
5 Nov 17
EFFECT
Notice of effectiveness
1 Oct 17
CORRESP
Correspondence with SEC
26 Sep 17
EFFECT
Notice of effectiveness
8 Dec 16
Ownership
4
MEDICINOVA / Geoffrey OBrien ownership change
31 Jan 22
4
MEDICINOVA / Kazuko Matsuda ownership change
31 Jan 22
4
MEDICINOVA / YUICHI IWAKI ownership change
31 Jan 22
4
MEDICINOVA / Kazuko Matsuda ownership change
25 Aug 21
3
MEDICINOVA / Douglas Paulin ownership change
10 Aug 21
4
MEDICINOVA / YUICHI IWAKI ownership change
23 Jul 21
SC 13G/A
MEDICINOVA / BlackRock ownership change
12 Jul 21
4
MEDICINOVA / Kazuko Matsuda ownership change
28 Jun 21
4
MEDICINOVA / Hideki Nagao ownership change
21 Jun 21
4
MEDICINOVA / CAROLYN BEAVER ownership change
21 Jun 21
Patents
Utility
Combination of ibudilast and riluzole and methods of using same
22 Mar 22
The present disclosure relates generally to methods for treating neurodegenerative diseases, including their progressive forms.
Utility
Methods of treating ophthalmic disease/disorder or injury with ibudilast
26 Oct 21
This disclosure is directed to methods of treating ophthalmic disease/disorder or injury associated with neurodegenerative disease/disorder, such as progressive multiple sclerosis, or a neuro-ophthalmologic disorder in human patients using ibudilast.
Utility
Methods of Reducing Plasma Level of Macrophage Migratory Inhibitory Factor In Patients
7 Oct 21
Disclosed is a method of reducing plasma level of macrophage migratory inhibitory factor in a subject in need thereof, the method comprising administering to the subject a therapeutically effective amount of ibudilast, or a pharmaceutical salt thereof.
Utility
Treatment of progressive neurodegenerative disease with ibudilast
10 Aug 21
Compositions and methods for treating progressive neurodegenerative diseases, and their associated symptoms by administration of ibudilast (3-isobutyryl-2-isopropylpyrazolo[1,5-a]pyridine).
Utility
Methods of Suppressing Myeloid-derived Suppressor Cells In Patients
17 Jun 21
Methods of suppressing myeloid-derived suppressor cells (MDSCs), reducing immune suppression, reducing regulatory T-cell count and increasing CD4+ T-cell count in cancer patients using ibudilast.
Reddit threads
Daily Discussion Thread - May 12th, 2022
12 May 22
Daily Discussion Thread - May 11th, 2022
11 May 22
This is an explosive short squeeze opportunity - HUGE: CSE / HUGE: NASDAQ
3 May 22
Interesting email received from investment banker in Europe - HUGE: CSE. HUGE: NASDAQ - FSD Pharma
3 May 22
Interesting email I received from an investment banker - HUGE: CSE. HUGE: NASDAQ - FSD Pharma
3 May 22
Pre-market summary April 11
11 Apr 22
Daily Discussion Thread - March 31st, 2022
31 Mar 22
Daily Discussion Thread - March 30th, 2022
30 Mar 22
Daily Discussion Thread - March 29th, 2022
29 Mar 22
Daily Discussion Thread - March 28th, 2022
28 Mar 22