Lee H. Latimer Joins NeurOp to Manage Its Chemistry Operations

NeurOp, Inc. announces that Lee H. Latimer, Ph.D., has been appointed as its head of chemistry. He will oversee the company’s chemistry program to support its drug development initiatives for the treatment of depression, neuropathic pain, ischemia (stroke), schizophrenia and other central nervous system disorders.

Dr. Latimer was most recently a consultant to the pharmaceutical and biotechnology industries and provided expertise in process, analytical and medicinal chemistry. Prior to that, he was the senior director of process and analytical chemistry at Elan Pharmaceuticals. He successfully led in-house and outsourced oversight and development of GMP routes to five clinical candidates in its Alzheimer’s disease and multiple sclerosis programs. Dr. Latimer is also an inventor of semagacestat, which reached phase III clinical trials for Alzheimer’s disease in collaboration with Eli Lilly.

“Lee brings a wealth of development experience to NeurOp at a time when our internal programs are advancing into clinical development,” said Barney Koszalka, Ph.D., president and CEO at NeurOp. “His work in early-stage medical chemistry programs will also greatly contribute to our ongoing efforts to develop new modulators of the NMDA receptor through our collaboration with Emory University.”

Dr. Latimer earned his Ph.D. in organic chemistry from the University of Wisconsin under the mentorship of B.M. Trost and held an NIH Fellowship with W.G. Dauben at the University of California at Berkeley and C.J. Sih at the University of Wisconsin at Madison. He is an American Chemical Society Fellow.

About NeurOp

NeurOp, Inc. is an Atlanta-based biopharmaceutical company developing new medicines for central nervous system disorders, including depression, neuropathic pain, ischemia (stroke), schizophrenia, and Alzheimer’s and Parkinson’s diseases. Its research targets various subunits of neuronal NMDA receptors and their potential therapeutic benefit. The company has a research collaboration and licensing agreement with Bristol-Myers Squibb for the development of NeurOp’s compounds for the treatment of depression and neuropathic pain. Multi-year funding from the NIH supports the company’s research and development programs for schizophrenia and NP10679, its drug candidate for the prevention of ischemic damage. For more information, please visit www.neuropinc.com.

NeurOp contact:

Barney Koszalka, CEO
Phone: 404.941.2350

 

NeurOp Selects NP10679 as Development Candidate for SAH

NeurOp, Inc. has selected NP10679 as a development candidate for the prevention of ischemic damage and its consequences in persons receiving surgical treatment for subarachnoid hemorrhage (SAH). NP10679 is a GluN2B subunit-specific modulator designed to work at the site of ischemic insult.

NeurOp has begun late-stage preclinical development studies with this candidate with the goal to file an IND in 2015.

This news follows the publication of related research by NeurOp’s director of drug discovery, Scott J. Myers, Ph.D., in collaboration with a number of other scientists. In February, Neurocritical Care published their paper entitled “pH-Sensitive NMDA Inhibitors Improve Outcome in a Murine Model of SAH.”

The manuscript demonstrates that the use of a pH-dependent NMDA antagonist has the potential to work selectively in areas of ischemia known to undergo acidic pH shifts, which occur during SAH. Because of their regional selectivity, these NMDA antagonists may also be associated with fewer behavioral side effects than non-selective NMDA antagonists.

NeurOp contact:
Barney Koszalka, CEO
Phone: 404.941.2350

 

Letter to Shareholders | 2013 Highlights

Dear NeurOp Shareholder:

Within the last year, NeurOp has witnessed both financial challenge and significant scientific progress. Most importantly, our NMDA receptor drug discovery effort has matured from being exclusively engaged in early-stage preclinical work to one that maintains cutting-edge target validation and lead identification, while moving selected development candidates through late-stage studies that lead to clinical testing.

Our development candidates are aimed at areas of significant medical need, with initial clinical targets of treatment-resistant depression and subarachnoid hemorrhage. We have also made progress and remain engaged in efforts to identify additional applications for NMDA receptor modulators, such as controlling craving in addiction, improving cognitive function in Alzheimer’s disease, and motor performance in Parkinson’s disease.

Depression
The beginning of 2013 signaled the internalization of the depression program by Bristol-Myers Squibb. This marked the end of a productive three-year research phase of our agreement with BMS where NeurOp played a central role. In November 2013, BMS announced a major change in their research strategy that led to the discontinuation of many preclinical and clinical CNS programs. Our depression program was continued, however, and BMS remains committed to this late-stage preclinical program for depression and neuropathic pain. Lead optimization efforts have led to the identification and selection of a single lead molecule, as well as potential backups. BMS expects to elevate the lead to advanced-lead status this quarter and is expecting to declare it a clinical candidate later this year. We look forward to clinical candidate nomination and the initiation of studies to support Investigational New Drug (IND) filing with the FDA.

Ischemia & Addiction
Our ischemia research program identified a development candidate in 2013, and pre-IND studies have begun. NIH funding to complete large-scale synthesis and advanced toxicology studies was delayed until the end of the first quarter of 2014. This delay, which added seven additional months to our development timeline, was due to a multitude of issues, including the government shutdown in October, a lengthy review of the program’s data, and the bureaucracy of clearing funds through the NIH. However, the acceptance of NP10679 by the NIH as a development candidate was a major milestone for NeurOp, and we are on track to deliver an IND in 2015. The initial target for this therapy is prevention of ischemic damage and its consequences in persons receiving surgical treatment for subarachnoid hemorrhage.

The identification of multiple advanced compounds for ischemia has provided opportunities to study additional therapeutic applications. We have initiated investigation of our compound’s ability to influence addiction, specifically lessening the cravings associated with nicotine and opiate addiction, in collaboration with a leading researcher at Medical University of South Carolina. We are working toward a proposal to support advanced research in this area to better understand the value of applying our compounds to prevention of drug abuse and addiction.

Leveraging the NMDA Platform
Last year we told you about a NeurOp-Emory University collaborative research program to discover modulators of two subunits of the NMDA receptor beyond GluN2B (i.e. GluN2C and GluN2D). Rationale exists that supports the idea that subunit-selective modulators of these subunits may provide a novel class of antipsychotic drugs, as well as new treatments for Parkinson’s and Alzheimer’s diseases.

Our effort in this area was curtailed in the latter part of 2013 due to budget constraints. We are hopeful that recent interest by a major pharmaceutical organization to fund this research will lead to a research collaboration agreement in the near future and allow resumption of NeurOp’s GluN2C and GluN2D programs.

Looking Forward
In 2014, we anticipate that the depression program will reach the first milestone with BMS and trigger a payment to NeurOp. We also expect to complete critical pre-IND studies for NP10679, our compound for the ischemia indication, and advance this compound to the 28-D toxicology studies needed for filing an IND by end of 2015.

Meeting these objectives will require securing additional funding. Earlier this year, we raised $170,000 via convertible debt. The round was funded by members of the existing board and Mario Family Partners. Seeking additional funding is a top priority. Importantly, the current government grants do not cover the entire development costs of the NP10679 program, which is a key component of value generation for the company.

In 4Q 2013, we made a difficult decision and reduced our research staff to conserve our cash. Our value position is best improved by focusing the available cash on our development programs. We are also closely monitoring any developments at BMS that will indicate a change in priority in the depression program.

In this time of reduced federal and state budgets for R&D, we are looking at more traditional routes to fund our advancing development programs. We have raised over $11.5 million in funding from BMS, investors, government and industry sources, and almost 90 percent of this funding is non-dilutive. These funds provided the compounds and intellectual property that have built the value of NeurOp to what it is today. With our compounds moving into the clinic, the cost of these programs is projected to rise significantly, and we will be prepared to meet this challenge.

In Conclusion
The scientific news around modulating the NMDA receptor continues to be very positive. Recently, four new reports were published in scientific peer-reviewed journals that build on previous work documenting the beneficial effects of modulating the NMDA receptor for treating depression and suicidal ideation. Together, the studies represent robust clinical evidence showing a significant rapid and sustained response to treatment, usually within hours of starting the therapy. There is a critical unmet medical need for faster-acting and more effective therapies for treatment-resistant depression and suicidal ideation associated with both unipolar and bipolar depression. NeurOp’s approach of NMDA modulation may lead to treatments that meet this need.

Each year, we move our programs closer to the clinic while also seeking new potential areas of interest. I believe NeurOp’s NMDA-centered drug research is getting closer to achieving our goal of introducing novel approaches to treating both mood and neurodegenerative disorders that are such a burden to so many in our society. I look forward to updating you throughout the year on our progress.

Very sincerely yours,

George Koszalka, Ph.D.
President and Chief Executive Officer

NeurOp, Inc.
We are committed to keeping you informed of our progress. You may sign up on our website to receive our latest news through an RSS feed. We also post news to our LinkedIn page, so you may wish to follow us there.

NeurOp Receives Third Year of NIH Funding for Ischemia Research

NeurOp, Inc. has received $700,000 in funding as part of a $3 million National Institutes of Health (NIH) award to support its cerebral ischemia development program. This third year of funding from the NIH will support pre-IND and additional efficacy studies for NeurOp’s proprietary development candidate. First announced in July 2011, the NIH grant is a four-year award that provides annual financial support to NeurOp upon successfully meeting its scientific and development milestones.

“We identified a development compound last year with unique characteristics that modulate over-active NMDA receptors through a specific subunit,” commented Barney Koszalka, Ph.D., CEO of NeurOp. “Our primary focus with this compound is to develop it for treating patients that have suffered a subarachnoid hemorrhage (SAH).”

NeurOp will initially study its candidate as a prophylactic treatment for SAH patients, which comprise up to seven percent of all stroke victims. Since about half of SAH patients suffer a stroke-like event within 14 days after surgery to repair the cerebral aneurysm, drug administration would begin immediately after surgery and be maintained through this critical period to improve survival and reduce neurological and cognitive insults should a stroke occur. If the compound proves safe and effective in SAH, NeurOp believes this approach can be expanded into other patients at risk of ischemic or traumatic brain injury, providing a much-needed new therapy to address these serious and costly areas of medical need.

This project is supported by Award Number U44NS071657 from the National Institute of Neurological Disorders and Stroke (NINDS).

NeurOp contact:
Barney Koszalka, CEO
Phone: 404.941.2350

NeurOp Receives Second Half of NIH Grant for Meeting Schizophrenia Research Milestones

NeurOp, Inc. has received $346,000 from the National Institutes of Health (NIH), the second half of a $700,000 grant made last year to support its schizophrenia treatment research. NeurOp is studying NR2C and NR2D subunit-selective NMDA receptor compounds as potential new antipsychotic medications.

“This grant required that we meet certain research objectives to qualify for the second year of funding, and I’m pleased to say that we accomplished those,” said Barney Koszalka, Ph.D., NeurOp president and chief executive officer. “In the next 12 months, our goal is to use these funds to advance the medicinal chemistry and pharmacology work that are needed to complete a proof of concept in animals.”

This project is supported by the National Institute of Mental Health of the National Institutes of Health under award number R43MH096363. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.

About Schizophrenia

Schizophrenia is a complex, disabling and chronic brain disorder that typically strikes in the early adult years and affects one percent of the world’s population. According to the National Institute of Mental Health, people with the disorder may hear voices that others do not. They may also believe other people are reading their minds, controlling their thoughts, or plotting to harm them. This can terrify people with the illness and make them withdrawn or extremely agitated. Symptoms such as hallucinations and delusions usually start between ages 16 and 30.

Because the causes of schizophrenia are unknown, treatments focus on eliminating the symptoms and include antipsychotic medications, designated as typical and atypical, and various psychosocial treatments.

About NeurOp

NeurOp, Inc. is an Atlanta-based biopharmaceutical company developing new medicines for central nervous system disorders, including depression, neuropathic pain, ischemia (stroke), schizophrenia, and Alzheimer’s and Parkinson’s diseases. Its research targets various subunits of neuronal NMDA receptors and their potential therapeutic benefit. A research collaboration and licensing agreement with Bristol-Myers Squibb currently funds and supports development of NeurOp’s compounds for the treatment of depression and neuropathic pain. Multi-year funding from the NIH supports its ischemia and schizophrenia research. For more information, please visit www.neuropinc.com.

NeurOp contact:

Barney Koszalka, CEO
Phone: 404.941.2350

 

Letter to Shareholders | 2012 Highlights

Dear NeurOp Shareholder:

Your continued support and enthusiasm for NeurOp’s NMDA receptor research helped us achieve many
notable milestones in 2012. We continue to advance a number of promising molecules that may one day
become new treatments for depression, subarachnoid hemorrhage, schizophrenia, PTSD, and Alzheimer’s and Parkinson’s diseases.

Depression
I am pleased to share that the progress made during the three-year research phase of our agreement with
Bristol-Myers Squibb has been dramatic. BMS will now drive this late-stage preclinical program for
depression and neuropathic pain from within their organization, and we look forward to the selection of a clinical candidate and the initiation of Investigational New Drug (IND) studies for these areas.

Ischemia & Traumatic Brain Injury
Our ischemia research program reached a major milestone this summer with the identification of two
compounds that are now undergoing detailed animal studies. The National Institutes of Health (NIH)
recognized our findings as a significant advancement, which triggered a second tranche of grant funding of close to a million dollars to study these molecules in more detail. First announced in July 2011, the NIH grant is a $3 million, four-year award that provides annual funding to NeurOp upon successfully meeting its project budget and certain milestones. Our focus remains on moving our lead molecules as rapidly as possible toward an IND filing for the treatment of subarachnoid hemorrhage and those patients at risk of a stroke.

The identification of molecules for advanced studies for ischemia has also opened up avenues of
investigation into traumatic brain injury and lessening the tragic effects for individuals exposed to blast injury.

Last year, we submitted a proposal to the U.S. Department of Defense seeking funding to develop
compounds that might provide neuroprotection for our soldiers when exposed to blast injury. Unfortunately, they didn’t elect to fund our initial proposal; however, agency feedback was encouraging enough that we are resubmitting the proposal in the second quarter of 2013. You may recall that our compounds only target areas of the brain affected by an ischemic event, so they may preserve brain function and retain more motor, speech and cognitive function in the event of an injury, as well as speed recovery.

Schizophrenia
In early 2011, NeurOp initiated research into GluN2C and GLuN2D subunit-selective modulators that may lead to a novel class of antipsychotic drugs. Later that year we submitted a funding proposal to the National Institute of Mental Health (NIMH) for support based on our early results. In April 2012, the NIMH funded a two-year, $700,000 research plan that allows us to further study these compounds. Our approach has also generated investment interest from major pharmaceutical companies as they look for promising science in earlier-stage research pipelines than they did in the past.

Schizophrenia affects one percent of the world’s population and can have tragic consequences for the
individual and those around them. The need is great for new, effective treatments, as there are a number of undesirable side effects related to current drugs. Increased tolerability will lead to better compliance and more stability in the lives of people affected by this debilitating mental illness.

NeurOp and Emory Scientists Target Cognitive and Mental Health Disorders
Just last month, we announced that NeurOp formed a three-year research collaboration with Emory
University to study NMDA receptor modulation and its possible impact on several serious cognitive and
mental health disorders – schizophrenia, post-traumatic stress disorder (PTSD), and Parkinson’s and
Alzheimer’s diseases. Working together, we believe we can move more quickly toward the goal of having
compounds in late-stage optimization with one or more compounds moving toward IND-enabling testing.

This collaboration combines the expertise of our scientists with Emory’s NMDA receptor researchers,
including its pharmacology team, led by Dr. Stephen Traynelis, and medicinal chemistry team of Dr. Dennis Liotta, who is also a member of NeurOp’s board of directors.

Corporate Development
The addition of Dr. Robert Zaczek into the newly created role of chief scientific officer helped us achieve
many of our milestones this year. Rob brought in-depth knowledge of neuroscience and an exemplary record of scientific achievement and drug development experience from BMS to our management team. While at BMS, he was executive director of psychiatry drug discovery and headed a multidisciplinary scientific group, which included the joint research team that currently collaborates with NeurOp on its depression and neuropathic pain programs. His teams also contributed to numerous discovery programs that led to the nomination of clinical candidates for affective disorders, schizophrenia and Alzheimer’s disease.

Looking Forward
In 2013, we anticipate that the depression program will continue to rapidly progress toward clinical candidate nomination. We also expect to nominate a compound for the ischemia indication and complete the advanced preclinical testing needed to understand the doses we need to achieve in man for efficacy. We believe the schizophrenia program will also make significant progress, and we will continue to evaluate some of our compounds in controlling addiction cravings.

To reach these goals, securing the necessary funding is a top priority for us. Governmental grants help and preserve the value of your investment; however, federal and state budgets for R&D are likely to be reduced.

Despite that, we have raised nearly $11 million in funding from BMS, investors, and government and industry sources, and 90 percent of this funding is from non-dilutive sources. Securing funding to maintain and grow the company is quite challenging in today’s economy and your management team is leaving no stone unturned in this endeavor. As we have in the past, we will continue to constantly monitor the bottom line and take advantage of creating strategic partnerships and outsourcing, where possible, to preserve our capital.

In conclusion
Hardly a day goes by that we don’t see something in the news about untreated or undertreated mental illness and cognitive disorders. Your continued support and investment are vital to advancing our important research in these areas. Serious, incapacitating brain conditions affect millions of people, yet doctors still have a relatively small medical arsenal with which to treat them. Each year, I believe NeurOp’s NMDAcentered drug research is getting closer to changing that. I look forward to updating you throughout the year on our progress.

Very sincerely yours,

George Koszalka, Ph.D.
President and Chief Executive Officer
NeurOp, Inc.

We are committed to keeping you informed of our progress. You may sign up on our website to receive our latest news through an RSS feed. We also post news to our LinkedIn page, so you may wish to follow us there.

NeurOp and Emory Scientists Target Cognitive and Mental Health Disorders

Schizophrenia, PTSD, Parkinson’s and Alzheimer’s Diseases Focus of Research Collaboration

 

NeurOp, Inc. has formed a research collaboration with Emory University to study modulation of certain brain cell receptors and its possible impact on several serious cognitive and mental health disorders – schizophrenia, post-traumatic stress disorder (PTSD), and Parkinson’s and Alzheimer’s diseases. NeurOp, a biopharmaceutical company, is working with Emory to accelerate NMDA (N-methyl D-aspartate) receptor research into potential new treatments for these areas of medical need.

“This three-year collaboration is based on our joint belief that NeurOp and Emory working together can speed the development of new medicines for certain central nervous system illnesses,” commented Dr. Robert Zaczek, chief scientific officer at NeurOp. “At the end of the period, our goal is to have compounds in late-stage optimization with one or more moving toward Investigational New Drug (IND) enabling testing.”

The collaboration combines the expertise of NeurOp scientists with Emory University’s NMDA receptor researchers, including its pharmacology team, led by Dr. Stephen Traynelis, and medicinal chemistry team of Dr. Dennis Liotta. These three groups of researchers aim to progress select molecules through late-stage lead optimization. Lead optimization is the complex process of refining the chemical structure of a biologically active compound to improve its drug characteristics, with the goal of producing a pre-clinical drug candidate.

Dennis Liotta, Ph.D., is the Samuel Candler Dobbs Professor of Chemistry at Emory University where he has been a faculty member for more than 25 years. He is a renowned organic and medicinal chemist and the author of approximately 200 publications and patents. Dr. Liotta’s research has focused on the discovery and development of novel antiviral and anticancer agents. Stephen Traynelis, Ph.D., is a professor of pharmacology at Emory University School of Medicine, where he has been a faculty member since 1994 and author of more than 300 papers, abstracts and patents. He is an expert on NMDA receptor activation and modulation.

“Steve and Dennis are global leaders in their respective fields. Coupled with NeurOp’s drug development team, we are positioned to quickly move the program forward,” said Barney Koszalka, Ph.D., NeurOp president and chief executive officer. “By combining our efforts and knowledge, we’ll gain a better understanding of how these compounds interact with various subunits of the NMDA receptor, which may yield exciting new treatments for a number of mental illnesses and nervous system disorders.”

About NeurOp
NeurOp, Inc. is an Atlanta-based biopharmaceutical company developing new medicines for central nervous system disorders, including depression, neuropathic pain, ischemia (stroke), schizophrenia, Alzheimer’s and Parkinson’s diseases. Its research targets various subunits of neuronal NMDA receptors and their potential therapeutic benefit. A research collaboration and licensing agreement with Bristol-Myers Squibb (NYSE: BMY) currently funds and supports development of NeurOp’s compounds for the treatment of depression and neuropathic pain. Multi-year funding from the NIH supports its ischemia and schizophrenia research. For more information, please visit www.neuropinc.com.