Minerva Neurosciences Stock

Minerva Neurosciences, Inc. (Minerva), a clinical-stage biopharmaceutical company, focuses on the development and commercialization of proprietary product candidates to treat patients suffering from central nervous system (CNS) diseases.

The company is developing roluperidone for the treatment of negative symptoms in patients with schizophrenia; and has exclusive rights to develop and commercialize MIN-301 for the treatment of Parkinson's disease. In addition, the company previously co-developed seltorexant with Janssen Pharmaceutica NV (Janssen) for the treatment of insomnia disorder and adjunctive treatment of Major Depressive Disorder (MDD). Janssen is conducting two Phase 3 studies with seltorexant, a third Phase 3 study was discontinued during 2022. The company completed certain pharmacology trials that include a Drug-Drug Interaction study, which comprise a standard part of the NDA. The company completed non-clinical studies that provide evidence of the effect of roluperidone on Brain-Derived Neurotrophic Factor (BDNF) and on Glial Cell-Derived Neurotrophic Factor (GDNF).

In August 2022, the company submitted a New Drug Application (NDA) with the U.S. Food and Drug Administration (the FDA) for its lead product candidate, roluperidone. The FDA subsequently notified the company that they would not accept the file for review, issuing a refusal to file letter in October 2022. In December 2022, the company announced that, following the Type A meeting held on November 30, 2022, the FDA confirmed that the refusal to file letter remains in effect with respect to its NDA for roluperidone. The company anticipates further discussion with the FDA over the coming months regarding the status of the roluperidone NDA and development program.

Strategy

The company's strategy is to develop and commercialize first-in-class products that address critical unmet medical needs in the CNS therapeutic area. The company is pursuing this strategy based on the following principles: selection of differentiated products with novel mechanisms of action that target therapeutic areas of high unmet need and significant disease burden; attention to patient safety and compliance; scientific rigor applied to patient selection and clinical trial conduct; engagement of highly trained clinical trial investigators; incorporation of patient and caregiver insights to drive clinical advancements; and integrity. With the experience and knowledge base of its clinicians and physicians, the company has generated substantive data from randomized, double blind, placebo-controlled trials that support the clinical advancement of these products in defined patient populations and in multiple regulatory jurisdictions.

The key elements of the company's strategy are to identify, acquire, and develop differentiated products with innovative mechanisms of action based on biological and clinical insights into the unmet needs of patients; leverage the randomized, double-blind, placebo-controlled data from completed trials to advance the clinical development of its product candidates in multiple regulatory jurisdictions; advance its lead product, roluperidone, which, if approved, will potentially be the first product approved to treat negative symptoms in patients with schizophrenia in the U.S. and, in the longer term as a potential treatment for other brain disorders in which negative symptoms represent a significant debilitating, unmet need; selectively explore collaborations with leading pharmaceutical companies to maximize the value of its current product candidate portfolio, particularly in connection with pivotal clinical trials and subsequent regulatory review, approval and commercialization; and apply its management team's expertise and current intellectual property portfolio to identify and explore additional indications to investigate with its current portfolio of compounds and to acquire additional product candidates.

Clinical-Stage Programs

Roluperidone (MIN-101)

The company is developing roluperidone to treat patients with schizophrenia. Roluperidone has been designed to block a specific subtype of serotonin receptor called 5-HT2A. When 5-HT2A is blocked, certain symptoms of schizophrenia, such as hallucinations, delusions, agitation and thought and movement disorders, as well as the side effects associated with antipsychotic treatments, can be minimized. Additionally, blocking 5-HT2A promotes slow wave sleep, a sleep stage often disrupted in patients with schizophrenia. Roluperidone has also been designed to block a specific subtype of sigma receptor called sigma2, which is involved in movement control, psychotic symptom control and learning and memory.

The company plans to seek approval of roluperidone initially as a first line treatment of negative symptoms in patients diagnosed with schizophrenia, and it also may study its use to treat all aspects of the disease, including positive symptoms and relapse prevention.

In August 2022, the company announced that it submitted an NDA to the FDA for roluperidone for the treatment of negative symptoms in patients with schizophrenia.

The company has a license agreement with Mitsubishi Tanabe Pharma Corporation (MTPC), as amended (Roluperidone License Agreement). Under the terms of the Roluperidone License Agreement, the company acquired an exclusive license to the lead compound known as CYR-101 (subsequently renamed MIN-101 and roluperidone), and other compounds with a similar structure and intended purpose and other data included within the valid claims of certain patents licensed to it under the Roluperidone License Agreement. The license is for world-wide rights other than certain countries in Asia, including China, Japan, India, and South Korea.

Seltorexant (MIN-202)

Seltorexant is an innovative selective orexin 2 receptor antagonist that the company co-developed with Janssen for the treatment of insomnia and MDD. Insomnia is the repeated difficulty with sleep initiation, maintenance or quality that occurs despite adequate time and opportunity for sleep, resulting in daytime impairment.

The company has its right to opt out of its agreement with Janssen for the future Phase 3 development and commercialization of seltorexant. Under the terms of the opt-out agreement, the company was entitled to collect royalties in the mid-single digits on potential future worldwide sales of seltorexant in certain indications, with no further financial obligations to Janssen. Janssen is conducting two Phase 3 studies with seltorexant, a third Phase 3 study was discontinued during 2022.

MIN-301

The company has exclusive rights to develop and commercialize MIN-301, a soluble recombinant form of the Neuregulin-1b1 (NRG-1b1), protein, for the treatment of Parkinson's disease and potentially for other neurodegenerative disorders. MIN-301 has the potential to slow the onset of, and restore the brain tissue damage caused by, the disease. MIN-301 is produced by recombinant technology, which is a type of process that modifies the genetics of a biological organism to cause it to produce a particular product. MIN-301 is a peptide that contains the extracellular domain of the human neureglin-1 beta 1 protein and is produced using an Escherichia coli organism that is genetically engineered to express this peptide.

Intellectual Property

The patent portfolios for the company's product candidates, which it owns or is exclusively licensed to the company, are summarized below.

Roluperidone

Compound

Minerva owns numerous granted patents and patent applications worldwide that provide strong protection for roluperidone. These include patents and applications directed to pharmaceutical compositions comprising roluperidone and methods of using roluperidone.

Pharmaceutical Compositions

The company owns four granted U.S. patents, U.S. Patent Nos. 9,458,130, 9,730,920, 10,258,614 and 10,799,493, and patents in Australia, Chile, Colombia, Europe, Israel, Mexico, and Ukraine, as well as pending applications in the U.S., Australia, Brazil, Canada, Chile, Eurasia, Europe, Israel, New Zealand, Peru, Ukraine, and South Africa that cover a novel formulation comprising roluperidone. This novel formulation provides improved therapeutic response and minimizes the potential for transient QTc increases - and thus safety issues - when compared to previous formulations. Because of this improved safety profile, it is this formulation of roluperidone that is being used in Phase 3 clinical trials, and it is this formulation that the company expects will be the basis for approval in the U.S. and European Union (EU). The granted U.S. patents, as well as any other U.S. or foreign patents that may grant from these applications, will expire no earlier than November 30, 2035. In addition to the patent terms, a patent term extension of up to 5 years may also be available.

The company also owns pending applications in the U.S., Australia, Brazil, Canada, Chile, Colombia, Europe, Israel, Mexico, New Zealand, Peru, Russia, Ukraine, and South Africa that cover gastro-resistant, controlled release dosage formulations of roluperidone. The terms of any future granted patents in this patent family would expire no earlier than June 21, 2038.

Methods of Use

The company owns U.S. Patent No. 9,732,059, three granted patents in Russia, a single patent in Canada, and a single patent in a number of European territories (Austria, Belgium, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Luxembourg, the Netherlands, Norway, Poland, Portugal, Spain, Sweden, Switzerland, Turkey, the United Kingdom, Anguilla, Bermuda, the Cayman Islands, Gibraltar, Jersey, Turks & Caicos Islands, and British Virgin Islands), as well as pending applications in the United States, Brazil, Canada, Europe, and Russia across two patent families that are directed to methods of use of roluperidone to treat negative and other symptoms of schizophrenia, sleep disorders, depression, and other sigma-2 disorders or conditions. U.S. Patent No. 9,732,059 covers the use of roluperidone to treat one or more negative symptoms of schizophrenia and will not expire until 2033. The foreign patents, as well as any future U.S. or foreign patents granting in these families, are scheduled to expire no earlier than July 20, 2031.

The company also owns U.S. and EP patent applications directed to the use of roluperidone to treat negative symptoms in non-schizophrenic patients. Any patents granting from these applications would expire no earlier than May 23, 2037.

In addition, the company owns a U.S. patent and pending applications in the U.S., Australia, Brazil, Canada, Chile, Europe, Israel, Mexico, New Zealand, Russia, Ukraine, the United Kingdom, and South Africa directed to the use of roluperidone to treat negative symptoms, various disorders (including autism disorders, amblyopia, personality disorders, traumatic brain injury), as well as increasing neuroplasticity and promoting neuroprotection in subjects in need thereof. The U.S. Patent and any future U.S. or foreign patents granting from these applications would expire no earlier than August 21, 2039.

MIN-301

The company owns a patent family that is directed to the use of MIN-301 for treating neurologic and psychiatric diseases, including Parkinson's disease. This patent family includes patents granted in the U.S., Australia, Brazil, Canada, Europe (Austria, Belgium, Denmark, France, Germany, Greece, Ireland, Italy, the Netherlands, Norway, Portugal, Spain, Sweden, Switzerland, Turkey, and the United Kingdom), Japan, Mexico, and Russia. Applications are also pending in the United States and Brazil. Any existing and future granted patents in this family will expire no earlier than November 17, 2028. A patent term extension of up to five years may be available in the United States.

Sigma Ligands

The company owns U.S. and PCT applications directed to sigma ligand compounds and their potential use in treating a variety of diseases and disorders, including pain disorders, CNS disorders (e.g., Parkinson's disease and Alzheimer's disease), viruses, and cancer. Any patents granting from the U.S. application, or any national phase applications that may be filed based upon the PCT application, would expire no earlier than August 12, 2041. A patent term extension of up to five years may be available in the United States.

Data and Marketing Exclusivity

In addition to patent protection, the company's product candidates may also be eligible for data and marketing exclusivity protection in the U.S., EU and certain other countries.

For small molecules, such as roluperidone, the data and marketing exclusivity period is generally five years in the U.S., measured from the FDA approval date.

Commercialization

Except for most of Asia, the company has global commercialization rights for roluperidone. The company also owns worldwide rights for MIN-301. Subject to receiving regulatory approvals, the company expects to commence commercialization activities by building a focused sales and marketing organization, either alone or through collaborations with third parties, in the United States, EU and Latin America to sell its product candidates.

Research and Development

For the year ended December 31, 2022, the company's research and development expenses were $14.6 million.

History

Minerva Neurosciences, Inc. was founded in 2007. The company, formerly known as Cyrenaic Pharmaceuticals, Inc., was incorporated in 2007.