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MediciNova(MNOV) - 2024 Q2 - Quarterly Report
2024-08-08 20:32
Financial Performance - Total operating expenses for the three months ended June 30, 2024, were $3,046,496, a decrease of 7.7% compared to $3,300,030 for the same period in 2023[8]. - The net loss for the three months ended June 30, 2024, was $2,628,200, compared to a net loss of $2,871,820 for the same period in 2023, representing a reduction of 8.5%[8]. - Basic and diluted net loss per common share for the three months ended June 30, 2024, was $0.05, an improvement from $0.06 for the same period in 2023[8]. - Comprehensive loss for the three months ended June 30, 2024, was $2,632,745, compared to $2,876,033 for the same period in 2023, indicating a decrease of 8.5%[8]. - Net loss for the six months ended June 30, 2024, was $5,382,718, compared to a net loss of $5,789,324 for the same period in 2023, representing a decrease of approximately 7.0%[13]. Operating Expenses - Research, development, and patents expenses for the six months ended June 30, 2024, totaled $3,427,918, compared to $3,212,411 for the same period in 2023, reflecting an increase of 6.7%[8]. - General and administrative expenses for the six months ended June 30, 2024, were $2,754,571, down from $3,050,862 in the same period of 2023, a decrease of 9.7%[8]. - Non-cash stock-based compensation for the six months ended June 30, 2024, was $422,885, down from $728,973 in the same period of 2023, a decrease of about 42.0%[13]. - Stock-based compensation expense for the six months ended June 30, 2024, totaled $422,885, a decrease of 42% from $728,973 in the same period of 2023[47]. Cash and Cash Equivalents - Cash and cash equivalents at the end of the period were $44,337,824, down from $52,876,271 at the end of June 2023, indicating a decrease of about 16.2%[13]. - The company reported a net cash used in operating activities of $6,679,178 for the six months ended June 30, 2024, compared to $5,560,429 for the same period in 2023, an increase of approximately 20.1%[13]. Equity and Stockholder Information - The total stockholders' equity as of June 30, 2024, was $57,405,154, down from $70,242,035 as of June 30, 2023[9]. - The Company granted 1,100,000 stock options under the 2023 Plan, with a weighted average exercise price of $1.51[46]. - As of June 30, 2024, there were 1,502,923 shares available for future grants under the 2023 Equity Incentive Plan[43]. - The estimated fair value of stock options granted during the six months ended June 30, 2024, was $0.99 per option, compared to $1.60 per option in the same period of 2023[49]. Lease Liabilities - As of June 30, 2024, total operating lease liabilities amounted to $492,530, a decrease from $626,586 as of December 31, 2023, reflecting a reduction of approximately 21.4%[36]. - The Company’s current operating lease liabilities decreased from $215,926 as of December 31, 2023, to $190,047 as of June 30, 2024, reflecting a reduction of approximately 12%[36]. - Cash paid for operating lease liabilities for the six months ended June 30, 2024, was $128,833, compared to $127,391 for the same period in 2023, indicating a slight increase of 1.1%[36]. - The right-of-use asset obtained in exchange for operating lease liability was $42,281 for the six months ended June 30, 2024, compared to $139,001 in the same period of 2023, showing a decrease of about 69.6%[13]. - The weighted-average remaining lease term as of June 30, 2024, was 2.47 years, down from 2.81 years as of June 30, 2023[36]. - The total minimum lease payments for the remaining six months of 2024 are projected to be $109,879[36]. Strategic Focus - The company is focusing on developing MN-166 and MN-001 for various serious diseases, including progressive multiple sclerosis and nonalcoholic fatty liver disease, indicating a strategic emphasis on unmet medical needs[15]. - The company operates in a single segment focused on the acquisition and development of small molecule therapeutics for serious diseases[19]. Accounting and Compliance - The company is currently evaluating the potential impact of new accounting standards on its consolidated financial statements and related disclosures[28]. Investment and Financing - The company had no proceeds from the disposal of investments in the current period, contrasting with $39,929,015 in the previous year, indicating a significant change in investment strategy[13]. - The Company has an at-the-market issuance sales agreement allowing for the sale of common stock up to an aggregate offering price of $75.0 million[50]. - No shares of common stock were sold under the ATM Agreement in the six months ended June 30, 2024 and 2023[51]. Diluted Earnings Per Share - The basic net loss per share is computed using the weighted average number of common shares outstanding during the period[51]. - Diluted net loss per share includes potentially dilutive securities, with 8,431,644 shares excluded for the three and six months ended June 30, 2024 due to anti-dilutive effects[51]. - For the same period in 2023, 8,286,416 shares were excluded from the diluted net loss per share calculation due to anti-dilutive effects[51].
MediciNova Chief Business Officer David H. Crean, Ph.D.
GlobeNewswire News Room· 2024-06-20 10:00
Company to rededicate efforts toward updating stakeholders on corporate vision, strategy, and ongoing activities 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 11 programs in clinical development, two of which are the ...
MediciNova Receives Notice of Allowance for New Patent Covering MN-166 (ibudilast) for the Prevention of Metastasis of Various Solid Cancer
GlobeNewswire News Room· 2024-06-05 10:00
Core Viewpoint - MediciNova, Inc. has received a Notice of Allowance from the U.S. Patent and Trademark Office for a patent covering MN-166 (ibudilast) aimed at preventing metastasis in various cancers, which is a significant advancement for the company and its intellectual property portfolio [1][3]. Patent Details - The patent, once issued, is expected to expire no earlier than July 2042 and covers the use of MN-166 in combination with various therapies such as chemotherapy, immunotherapy, and radiotherapy [2]. - The claims specifically address the prevention, amelioration, or minimization of metastasis in cancers including pancreatic, lung, breast, colorectal, melanoma, and ovarian cancers, with provisions for oral administration and varying doses and treatment periods [2]. Product Information - MN-166 (ibudilast) is a small molecule compound that inhibits phosphodiesterase type-4 (PDE4) and inflammatory cytokines, currently in late-stage clinical development for neurodegenerative diseases and other conditions [4]. - The compound is in Phase 3 trials for amyotrophic lateral sclerosis (ALS) and degenerative cervical myelopathy (DCM), and is also being evaluated for Long COVID and substance use disorder [5]. Company Overview - MediciNova, Inc. is a clinical-stage biopharmaceutical company with a diverse late-stage pipeline focused on inflammatory, fibrotic, and neurodegenerative diseases, with 11 programs in clinical development [5]. - The company has a strong track record of securing investigator-sponsored clinical trials funded through government grants, enhancing its research capabilities and potential for future growth [5].
MediciNova Announces Data from Phase 1b/2a Clinical Trial of MN-166 (ibudilast) in Glioblastoma Patients at the American Society of Clinical Oncology (ASCO) Annual Meeting 2024
GlobeNewswire News Room· 2024-06-03 10:00
LA JOLLA, Calif., June 03, 2024 (GLOBE NEWSWIRE) -- MediciNova, Inc., a biopharmaceutical company traded on the NASDAQ Global Market (NASDAQ: MNOV) and the Standard Market of the Tokyo Stock Exchange (Code Number: 4875), today announced that MediciNova's collaborator, Gilbert Youssef, M.D. at Harvard Medical School, Attending Physician, Center for Neuro-Oncology at Dana-Farber Cancer Institute and Brigham and Women's Hospital, presented new data and results of a Phase 1b/2a Clinical Trial of MN-166 (ibudila ...
MediciNova Announces Two Poster Presentations at the 92nd EAS Congress 2024, the Annual Meeting of the European Atherosclerosis Society Regarding the Use of MN-001 (Tipelukast) for Cardiometabolic Conditions
Newsfilter· 2024-05-28 10:00
MediciNova's Dr. Huicheng Qi presented "MN-002, THE METABOLITE OF MN-001 (TIPELUKAST) PROMOTES MACROPHAGE CHOLESTEROL EFFLUX (Abstract # 856)", demonstrating positive data regarding cholesterol efflux capacity by MN-001 (Tipelukast) and MN-002. This is a collaborative effort between MediciNova and Professor Masatsune Ogura at Department of Clinical Laboratory Technology, Juntendo University and Professor Takashi Miida at Department of Clinical Laboratory Medicine, Juntendo University. Objectives of this stu ...
MediciNova Announces Two Poster Presentations at the 92nd EAS Congress 2024, the Annual Meeting of the European Atherosclerosis Society Regarding the Use of MN-001 (Tipelukast) for Cardiometabolic Conditions
globenewswire.com· 2024-05-28 10:00
LA JOLLA, Calif., May 28, 2024 (GLOBE NEWSWIRE) -- MediciNova, Inc., a biopharmaceutical company traded on the NASDAQ Global Market (NASDAQ: MNOV) and the Standard Market of the Tokyo Stock Exchange (Code Number: 4875), today announced that MediciNova conducted two poster presentations at the 92nd European Atherosclerosis Society (EAS) 2024 Congress held online May 26-29, 2024. MediciNova's Chief Medical Officer, Kazuko Matsuda, MD PhD MPH presented an update on the Company's "STUDY PROTOCOL TO EVALUATE MN- ...
MediciNova Receives Notice of Allowance for New Patent Covering MN-166 (ibudilast) for the Prevention of Metastasis of Eye Cancer
globenewswire.com· 2024-05-20 10:00
LA JOLLA, Calif., May 20, 2024 (GLOBE NEWSWIRE) -- MediciNova, Inc., a biopharmaceutical company traded on the NASDAQ Global Market (NASDAQ:MNOV) and the Standard Market of the Tokyo Stock Exchange (Code Number: 4875), today announced that it has received a Notice of Allowance from the U.S. Patent and Trademark Office for a pending patent application which covers MN-166 (ibudilast) for the prevention of metastasis of eye cancer. Once issued, this patent is expected to expire no earlier than July 2042. The a ...
MediciNova(MNOV) - 2024 Q1 - Quarterly Report
2024-05-09 20:15
Financial Performance - Total current assets decreased from $51,174,380 on December 31, 2023, to $47,863,595 on March 31, 2024, a decline of approximately 6.4%[15] - Operating expenses increased to $3,135,993 for the three months ended March 31, 2024, compared to $2,963,243 for the same period in 2023, representing a rise of about 5.8%[17] - The net loss for the first quarter of 2024 was $2,754,518, a slight improvement from the net loss of $2,917,504 in Q1 2023, indicating a reduction of approximately 5.6%[17] - Cash and cash equivalents decreased from $50,999,442 at the beginning of the period to $47,138,799 at the end of March 2024, a decrease of about 7.5%[22] - The total stockholders' equity decreased from $62,378,424 on December 31, 2023, to $59,830,444 on March 31, 2024, a decline of about 4.4%[15] - The company reported interest income of $397,510 for Q1 2024, down from $509,046 in Q1 2023, reflecting a decrease of approximately 22%[17] - The company’s cash flow from operating activities for Q1 2024 was $(3,868,248), compared to $(3,177,413) in Q1 2023, indicating an increase in cash used in operations[22] - The accumulated deficit of the company reached $418.5 million as of March 31, 2024, indicating significant net losses since inception[68] Research and Development - Research and development expenses totaled $1,781,869 for Q1 2024, up from $1,476,676 in Q1 2023, marking an increase of approximately 20.6%[17] - The company plans to advance the development of MN-166 (ibudilast) through a combination of investigator-sponsored clinical trials and trials funded by government grants[70] - The company has incurred research, development, and patents expenses primarily related to clinical development, with expectations to increase these costs through the remainder of 2024[76] - Research, development, and patents expenses increased to $1.8 million for the three months ended March 31, 2024, compared to $1.5 million in the same period of 2023, primarily due to higher manufacturing costs for MN-166[85] - Future potential milestone payments for product development total $26.5 million as of March 31, 2024, with $10 million related to MN-166 and MN-001[48] Stock and Equity - The company has maintained its common stock at 49,046,246 shares issued and outstanding as of March 31, 2024, consistent with the previous quarter[19] - As of March 31, 2024, 1,355,923 shares remain available for future grants under the 2023 Equity Incentive Plan[52] - The Company adopted the 2023 Equity Incentive Plan in June 2023, succeeding the 2013 Plan, with a maximum of 9,934,567 shares potentially available for issuance[51] - As of March 31, 2024, the company had a total of 1,016,000 shares underlying performance options subject to vesting based on achievement of corporate objectives for 2024[53] - The total stock-based compensation expense for the three months ended March 31, 2024, was $215,430, a decrease of 46.5% compared to $403,263 for the same period in 2023[56] - The weighted-average fair value of each stock option granted during the three months ended March 31, 2024, was $1.00, down from $1.60 in 2023[58] - As of March 31, 2024, there were 8,578,644 potentially dilutive outstanding stock options excluded from diluted net loss per share due to their anti-dilutive effect[63] Lease and Operating Expenses - The Company reported cash paid for operating lease liabilities of $64,594 for the three months ended March 31, 2024, compared to $64,990 for the same period in 2023[45] - Total operating lease liabilities as of March 31, 2024, amounted to $569,072, down from $626,586 as of December 31, 2023[45] - The weighted-average remaining lease term is 2.60 years, with a weighted-average discount rate of 9.3%[45] - General and administrative expenses decreased to $1.4 million for the three months ended March 31, 2024, from $1.5 million in the same period of 2023, mainly due to a reduction in performance-based stock option expenses[86] Strategic Partnerships and Future Plans - The company intends to pursue strategic partnerships with leading pharmaceutical companies to support clinical development and commercialization of its products[70] - The Company is currently evaluating the potential impact of ASU 2023-07 on its consolidated financial statements and related disclosures, effective for fiscal years beginning after December 15, 2023[39] - The company has not made any milestone payments under its licensing agreements during the three months ended March 31, 2024[48] - The company believes it carries reasonably adequate insurance for product liability risks associated with its drug products[46] - The company has not experienced any material changes in its critical accounting policies during the three months ended March 31, 2024[82] Cash Position - As of March 31, 2024, the company had available cash and cash equivalents of $47.1 million and working capital of $45.4 million, sufficient to fund operations at least through the end of 2025[90] - Net cash used in operating activities was $3.9 million for the three months ended March 31, 2024, compared to $3.2 million in the same period of 2023, reflecting a $0.7 million change related to decreased net loss[88] - The company has not sold any shares of common stock under the ATM Agreement in the three months ended March 31, 2024, and 2023[61] - No shares of common stock were sold under the at-the-market issuance sales agreement in the three months ended March 31, 2024, and 2023[92]
MediciNova Receives Issue Notification for New Patent Covering Extended-Release Formulations of MN-166 (ibudilast)
Newsfilter· 2024-05-07 10:00
LA JOLLA, Calif., May 07, 2024 (GLOBE NEWSWIRE) -- MediciNova, Inc., a biopharmaceutical company traded on the NASDAQ Global Market (NASDAQ:MNOV) and the Standard Market of the Tokyo Stock Exchange (Code Number: 4875), today announced that it has received an issue notification from the U.S. Patent and Trademark Office for a new patent which covers extended-release oral formulations of MN-166 (ibudilast). This new patent is expected to expire no earlier than September 2040. The allowed claims cover a formula ...
MediciNova(MNOV) - 2023 Q4 - Annual Report
2024-02-15 21:25
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 Form 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2023 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from. to Commission file number: 001-33185 MEDICINOVA, INC. (Exact Name of Registrant as Specified in its Charter) Delaware 33-0927979 (State or Other Jurisdiction of Inc ...