Strategy
Rather than focus on a single product or indication, the larger opportunity lies in building a robust and diverse product pipeline of high-value potential drug candidates to treat psychiatric illnesses. We are an Intellectual Property (IP) Centric Company. IP is at the center of everything we do. We believe it is management's responsibility to invest tens of millions of dollars to develop product candidates that have a strong, proven intellectual property base.
Development strategy
Partnering is a key part of our strategy and our team of drug hunters is continuously on the lookout for innovative technologies and assets with strong patents. We take a broad, multi-pronged approach to identify drugs that can be repurposed as drug candidates for psychiatric disorders.
Our pipeline development strategy reflects a blended approach to manage risk and catalyze partnerships that enable access to non-dilutive capital, and increase speed.
pipeline
The programs in our diversified portfolio of product candidates are based on our deep expertise in the biology of CNS diseases and were selected through a rigorous process by our team. All programs represent reduced risk approaches, and our patented product candidates meet the criteria to be acquired by or partnered with Big Pharma.
Our business development strategy is to take a blended approach. To reflect this, our pipeline will consist of co-developed assets and wholly owned assets. Our core portfolio consists of programs at various stages of clinical and pre-clinical development that have the potential to improve the lives of millions of people in the USA and beyond.
Lead product candidate
LMI-107, together with its proprietary dosage form, will be developed to meet the requirements of women undergoing cancer therapy. Depending on the results of the Phase 2B trials, it represents a highly valuable asset for Big Pharma partners. The product profile is uniquely differentiated and positioned to help a vulnerable population. Beyond VMS caused by endocrine therapy, cluster analysis shows that pain and depression are often present, driving many women to discontinue potentially life-saving medications.
PROBLEM
In the United States, approximately 1 million women with hormone receptor-positive breast cancer rely on aromatase inhibitors for treatment. This most common type of breast cancer requires estrogen to grow and survive. Aromatase is a key enzyme in estrogen biosynthesis. By inhibiting aromatase, estrogen levels plummet, effectively treating the cancer but often triggering vasomotor symptoms (VMS), such as debilitating hot flashes. Pain and depression are also common co-morbidities.
Current guidelines recommend at least 5 years of aromatase inhibitor therapy for postmenopausal women, with evidence supporting extended therapy up to 10 years for additional benefit. However, severe VMS has led approximately 250,000 women to discontinue therapy, a number that continues to rise. Of 195,000 women starting endocrine therapy each year, ~25% (~48,750 women) will stop their treatment prematurely due to these side effects, highlighting a critical gap in care.
The consequences of discontinuation are really important. Stopping aromatase inhibitor therapy raises recurrence rates and increases mortality risk by ~20–30%. Recurrence often manifests as stage 4 metastatic breast cancer, which is closely associated with poor survival outcomes. Adherence to the full course of therapy is essential to reduce recurrence and improve survival.
SOLUTION
LMI-107 offers a transformative solution. It not only treats VMS but also addresses depression, a common and debilitating comorbidity in this population. With a well-characterized safety and side effect profile, LMI-107 is energizing without causing anxiety. Unlike SSRIs, it does not lead to weight gain, impair sexual function, or affect cognition—key concerns for patients.
By effectively managing both VMS and depression, LMI-107 can improve long-term adherence, enabling patients to fully benefit from the 40–50% reduction in recurrence risk offered by aromatase inhibitors. Beyond adherence, it significantly enhances quality of life by alleviating the physical and emotional burdens of treatment.
Team History - Repurposing
Drug repurposing refers to the process of identifying new indications for existing FDA-approved drugs, product candidates under development, and abandoned compounds. The advantage of repurposing is that it significantly reduces the time required for development since the safety of the compound has often been tested. In fact, approximately 30 percent of repurposed drugs ultimately reach patients, which is a substantial improvement compared to the 10 percent success rate of the traditional drug development process.
Our team has successfully worked together to repurpose drugs and devices in several other successful companies like these below and has created significant value for patients and stakeholders.
Artificial intelligence (AI)
Drug repurposing depends on massive observed data from existing drugs and diseases. We utilize AI approaches for the systematic identification of drug repurposing leads based on big data resources.
AI plays a crucial role in providing researchers with tools to model and navigate the biological networks in which drug targets reside. AI of various architectures, themselves inspired by neural networks, learn and expose the implicit rules that govern the performance of biological pathways in health and disease. AI also provides us with predictions of previously unknown connections identifying successful new drug-target combinations.
In-Licensing Drug Programs
Often, pharmaceutical and biotech companies decide to curtail programs that are no longer a priority due to business decisions and not for scientific reasons. Many of these programs are fairly advanced, from a development prospective, where much of the early clinical work has been performed, and the drug is ready for further clinical testing.
In the current financial environment, in-licensing opportunities offer additional advantages to companies who need to focus on their primary assets, while maintaining an investment in their original work. This offers us a unique situation to in-license these advanced assets.
We are able to move quickly to a clinically viable drug, which provides a substantial cost savings. This strategy has the advantage of de-risking the early stages of drug discovery and development, which ultimately will lead to a more rapid timeline to achieving a ROI.
pharmaceutical patents
We seek "composition of matter" patents, also called product patents – the strongest possible type of patent which is not circumventable. This is what our substantial partners require.
We are not proponents of formulation, crystalline forms, and process patents. Our product candidates meet the stringent criteria for partnering with Big Pharma.
