Empath Biosciences, Inc

Empath Biosciences, Inc
One-Liner

Empath Biosciences has developed a revolutionary drug discovery platform that overcomes barriers to scaling therapeutics from nature’s biodiversity, de-risks each step of the development process, and efficiently yields novel therapeutics. The lead, proof-of-principle chemical series is currently in IND-enabling studies and scheduled to be in the clinic in 2026.

Institution
Stage
Company Formed
Company Info

Current drug discovery is inefficient, slow, and costly; only a transformative approach to de-risk and economize discovery will deliver novel cancer therapeutics to suffering patients. To this end, Empath Biosciences has developed a process which will lead to a three-fold increase in optimized leads, each with >50% improvement in the probability of technical and regulatory success (PTRS) over standard small-molecule based discovery. We achieve this volume of high-quality leads as we harvest bioactive compounds identified from novel or understudied bacteria in nature as a screening raw material to test against cells from primary cancer patients. Our discovery platform applies proprietary automated multiplexed activity profiling of microbial metabolomic arrays to redefine phenotypic drug discovery for efficient creation of precision medicines. We cannot continue to afford incremental gains in effective therapies, and Empath provides disruptive opportunities to rebuild the process of how we generate important new treatments for patients in need.

Team Members

Co-Founder, Brian Bachmann, PhD, Professor of Chemistry at Vanderbilt University was a pioneer in genome mining techniques over 2 decades ago as an industry chemist. Since, he has harvested and managed bacterial species from hypercompetitive environments leading to discovery of new chemical matter as basis of the Empath Platform.

Co-Founder, Michael Savona, MD, has translated laboratory discovery to the development of new approved treatments for cancer patients for decades.  He has led dozens of INDs and served as lead investigator on recent approved NDAs.

The co-founders are experienced across all stages of drug discovery and development, and have engaged seasoned industrial professionals for G&A, equity management, and fundraising.

John Volpone is former EVP at CTI Biopharma where he led Operations, and sale of the company in 2023.

David Earl, PhD, most recently at Adapsyn Biosciences, will lead the hypogean bacterial strain collection and sequencing, and drive early Platform development.  Many consultants.

Go-To-Market Strategy

Upon complete industrialization of the platform, Empath Biosciences will sustain via 3 specific revenue-generating channels:

  1. Sale/Licensing of optimized leads: compounds which Empath has prepared for IND study (or driven through pre-IND testing) will be licensed to pharmaceutical companies for further development.  
  2. Commercial licensing of validated hits: Empath improves PTRS by optimizing leads, but some chemical entities will be beyond Empath’s bandwidth and expertise to develop through IND-enabling work.  We will engage with pharmaceutical partners in licensing validated hits (early leads) prior to full optimization in these instances.
  3. Drug development and pursuit of NDA in the clinic by Empath. Empath’s lead clinical series (glycomacrolides) is currently in IND-enabling studies and will developed in AML. Glycomacrolides are first being developed in acute myeloid leukemia (AML).  AML is a vast unmet medical need, and our preclinical data indicated some of the best anti-cancer activity in AML.  

In addition, our co-founder has >20y experience in development of early compound in AML and other hematologic malignancies, leading dozens of INDs and as lead investigator on recent approved NDAs. To this end, Empath will raise funding to complete phase I dose-finding studies, as well as preliminary efficacy expansion studies. Further clinical development will likely occur with the partnership of large industry partners, and will include registration studies in AML, but also solid tumor indications as glycomacrolides are active in many cancers in preclinical assessment.

Revenue Generation

Empath is currently raising equity funding to support industrialization of the Empath Platform, completion of preIND studies, and phase I clinical studies for glycomacrolides.  Empath will continue to seek non-dilutional funding through grants.  While our revenue generation will likely not occur until after our second equity funding round, we do see opportunity to generate revenue prior to completion of the registration of glycomacrolides.

Benefits From Showcase

Empath Biosciences emanates from an ethos of empathy for patients, their families, our employees and their families, and the communities and environments it impacts. Compassion resides at the core of Empath Biosciences. Our humanistic values will fuel meaningful solutions for the people we aim to help and will drive our motivation and success. We will align with investors who share our core values, and share our enthusiasm in disrupting current drug discovery. We ask our investor partners to engage over the long term with guidance through, potentially, several funding rounds which will help us reach out potential developing new chemical matter from exceptionally talented bacterial organisms. Our ambition includes an asset approach clinic-ready status, but it goes far beyond this. To meet the drug discovery capacity we envision, the Platform will demand capital expenditures to industrialize, and uniquely talented natural product chemists, data scientists, microbiologists, and molecular expedition teams to generate our potential - all of this prior to revenue generation. In our first formal equity funding round, we aim to fund initial steps of Platform industrialization, and drive glycomacrolide development through IND-enabling studies, IND submission and agreement with FDA, and genesis of clinical trials. A year later, we envision a larger Series AA funding round will complete Platform industrialization and resource the completion of phase I expansion preliminary efficacy studies for lead glycomacrolide asset.

Technology Assesment

We enhance and de-risk an inherently speculative drug discovery process with innovations across several key domains. (A)-Novel bacteria:  >10e12 distinct bacterial species are estimated to remain undiscovered on Earth, and we search for the best in hyper-competitive microbial ecosystems and use these novel and under-discovered bacterial producers to generate the raw material for discovery; our library of novel bacterial genomes is being generated now.  By combining cell barcoding with multiplexed cytometric measurement of single cell associated extracellular and intracellular functional markers, we have created (B) Multiplexed Activity Metabolomics (MAM) a ‘targeted phenotype’ approach capable of creating deep phenotypic signals integrated from simultaneous assessment of myriad cell functional markers. With MAM, we de-risk discovery as we can identify hundreds of hits prior to isolation, and then concentrate resources on key leads for isolation and target identification. While organic chemistry solved some issue of toxicology (e.g. staurosporin to midostaurin, or epoxymcyin to carfilzomib), more expansive bioengineering was not possible with natural products until recently.  Empath uses expertise in chemical synthesis, as well as biocatalysis, and genome editing to modulate scaffolds of leads selected MAM bioassays (C-Synthetic modification). 

Empath's founders successfully validated the Platform, identifying F1-ATP as as the target of glycomacrolides (F1-ATPase).  This first novel asset class (glycomacrolides, from natural product, ammocidin) includes patent-protected analogs currently in IND-enabling studies.  We have contracted CDMO, CRO, and reached term agreements for the exclusive commerical license for the entire glycomacrolide chemical series.  Empath is bringing a lead glycomacrolide molecule to the clinic in 2026.

Money Received

Non-dilutional funding / Vanderbilt support Pre-seed investment (<$1M) Currently engaged in formal equity funding round 

Additional Features