Participated · Series G · Apr 2023

Epic Sciences develops and markets liquid‑biopsy diagnostics to guide therapy selection and monitor disease progression in prostate and breast cancers. Its flagship offering, DefineMBC, is a three‑component blood‑based biopsy that reports circulating tumor cell detection, HER2 and ER protein expression and single‑cell sequencing for ERBB2 amplification, alongside a 56‑gene plasma cell‑free DNA panel including ERBB2 and PIK3CA and tumor mutational burden. The company leverages proprietary cell analysis and cell‑free analysis in a CAP/CLIA‑accredited laboratory and provides Comprehensive Cancer Profiling to pharmaceutical partners and major cancer centers. Epic has delivered DefineMBC results to 700 patients and their oncologists through a Clinical Experience Program. In the past twelve months Epic raised $67 million across a $43M Series F and a $24M Series G to fund commercialization of DefineMBC. Proceeds are being used to build commercial infrastructure (sales, product marketing, customer service, medical affairs, payer markets and billing) and to generate additional concordance and outcomes data. Epic Sciences is a diagnostics company based in San Diego that develops and markets liquid biopsy tests and multi-omic cancer profiling to guide therapy selection and monitor disease progression in prostate and breast cancers. Its liquid biopsy platform combines proprietary cell analysis capabilities with cell-free DNA analysis to provide more complete, efficient cancer profiling. The company operates a full-service CAP/CLIA-accredited laboratory and provides research support services, partnering with pharmaceutical companies and major cancer centers worldwide. Epic's DefineMBC™ blood-based test for comprehensively characterizing metastatic breast cancer has been reporting patient results since April 2022 and uses multi-analyte methods to detect circulating tumor cells, assess protein expression (HER2, ER), determine intra-cell CNVs, and identify SNVs, indels, fusions, CNVs, MSI and TMB from plasma. The company plans to use the new capital to continue advancing its multi-omic platform and to expand operations in single-cell sequencing and data analytics infrastructure. Lloyd Sanders serves as President and CEO. Epic Sciences develops diagnostics and decision-support analytics that match patients’ individual cancer cells to individualized drug therapies using computer vision and machine learning. The company’s technology is aimed at prolonging life and reducing treatment costs by avoiding ineffective therapies. Epic is advancing oncology decision-support services in its pipeline and plans to accelerate clinical studies to validate and commercialize those offerings. Proceeds from the recent financing are expected to fund those clinical studies and support execution of its long-term growth plan. Epic is based in San Diego and positions its products for value-based, individualized cancer care. Epic Sciences, based in San Diego, develops blood-based liquid biopsy tests designed to predict drug response in cancer patients. Its core platform is the proprietary No Cell Left Behind technology and a portfolio of blood-based tests that characterize rare circulating cells using digital imaging and big data analytics. The company plans to use the funds to accelerate clinical studies for oncology tests in its pipeline and to enhance No Cell Left Behind to include characterization of rare leukocyte cell populations. These enhancements are intended to drive transformative insights into the cellular drivers of response or resistance to key drug classes such as immuno-oncology therapies. Epic recently partnered with Genomic Health to commercialize the OncotypeDx AR-V7 Nucleus Detect test and to leverage Genomic Health’s commercial channel and enterprise systems. Murali Prahalad, Ph.D., serves as president and CEO. Epic Sciences develops technology that enables comprehensive characterization of circulating tumor cells (CTCs) from a liquid biopsy to inform therapy selection and detect early signs of drug resistance. The company is led by Murali Prahalad, Ph.D., president and CEO. Epic offers products and offerings aimed at personalizing and advancing the treatment and management of cancer. The company expanded available capital under an existing credit facility, giving it optionality to accelerate expansion of research capabilities and product development efforts. The amended credit facility increases available capacity and extends the financing maturity, improving near‑term liquidity and runway for R&D. Epic is a private diagnostics company based in San Diego, CA.

Participated · Series B · Nov 2021

Antios is a clinical-stage biopharmaceutical company focused on developing innovative therapies to treat and cure viral diseases, with a lead program targeting chronic HBV. Its lead candidate, ATI-2173, is a once-daily oral investigational phosphoramidate prodrug of clevudine monophosphate and the only Active Site Polymerase Inhibitor Nucleotide (ASPIN) in clinical development. ATI-2173 is in Phase 2b development and is being evaluated in the SAVE-1 trial, a double-blind, randomized, placebo-controlled study of 30 patients testing 25 mg and 50 mg doses daily for 90 days in combination with tenofovir disoproxil fumarate (TDF). Preclinical data and Phase 1b results indicate potent on-treatment and durable off-treatment HBV DNA suppression and that the drug has been generally well-tolerated. The company plans to advance ATI-2173 through Phase 2b and further clinical development toward a potential curative once-daily HBV regimen. The recent $75 million financing strengthens Antios's financial position to support these clinical programs. Antios Therapeutics is a clinical-stage biopharmaceutical company focused on developing innovative therapies to treat and cure viral diseases. Its lead candidate, ATI-2173, is a novel, orally administered, liver-targeted Active Site Polymerase Inhibitor Nucleotide (ASPIN) designed to deliver the 5'-monophosphate of clevudine to the liver. ATI-2173 is described as a non-competitive, non-chain terminating HBV polymerase inhibitor that distorts the active site, producing potent antiviral activity and extended off-treatment suppression of HBV DNA. The company plans to advance ATI-2173 through a Phase 2 clinical program to evaluate its potential as the backbone of a once-daily curative regimen for chronic hepatitis B. Antios reported potent on-treatment and durable off-treatment effects in a Phase 1b study, with those results slated for presentation at an upcoming medical conference. To support development, Antios completed a $96 million Series B financing. Antios Therapeutics is an Atlanta, GA–based biopharmaceutical company focused on developing novel antiviral therapies for unmet medical needs. Its lead oral candidate, ATI-2173, is being advanced as part of a curative regimen for chronic hepatitis B virus (HBV) and potentially hepatitis D virus (HDV). The company targets chronic HBV, which affects over 250 million people worldwide and is a leading cause of chronic hepatitis, liver cirrhosis and liver cancer. Antios is led by co-founders Abel De La Rosa (CEO) and Douglas Mayers (CMO). The company intends to use proceeds from its recent financing to continue development of ATI-2173. The article does not disclose revenue or user metrics.

Participated · Series C · Oct 2021

Axial Therapeutics is advancing a pipeline of gut-targeted small-molecule drugs that act on defined mechanisms to mitigate the impact of metabolites and bacteria linked to neurological disease pathology via the microbiome gut-brain axis. Its lead candidate, AB-2004, is a first-in-class, gut-restricted molecular therapeutic that selectively sequesters certain bacterially derived metabolites and is being developed for irritability in children with autism; AB-2004 showed safety, metabolite reductions, and evidence of behavioral improvement in a Phase 1b/2a trial and is in Phase 2 development. The company’s discovery approach is rooted in the research of co-founder and chief scientist Dr. Sarkis Mazmanian at Caltech and aims to identify new gut targets for neurodevelopmental and neurodegenerative disorders. Axial is also pursuing preclinical gut-targeted programs including oncology and Parkinson’s disease. Financially, the company has raised $37.25 million in its recent Series C and $91.5 million in total funding to date, funds it intends to use to advance AB-2004 and its broader discovery platform. Axial Biotherapeutics is a clinical-stage biopharmaceutical company developing gut-targeted small molecules and live biotherapeutics that leverage the gut–brain axis to address CNS and other gut-derived diseases. The company’s pipeline includes lead programs targeting Parkinson’s disease and Autism Spectrum Disorder. Axial has built a discovery platform focused on the interaction between the brain and the gut and is expanding its application beyond CNS indications into oncology. Taiho Ventures invested $10 million as a direct investment to fund discovery and development of gut-targeted, small-molecule oncology approaches, and Sakae Asanuma will join Axial’s board as part of the investment. The $10M is an extension of Axial’s previously closed Series B in February 2019, bringing the total Series B financing to $35M. Axial will retain control and rights to its existing CNS programs while granting Taiho Ventures a first right to negotiate an exclusive license related to the new oncology programs. Axial Biotherapeutics is a clinical-stage biopharmaceutical company developing gut-targeted small-molecule programs that modulate the gut–brain axis for neurodegenerative and neuropsychiatric diseases. Its lead programs target Parkinson’s disease (PD) and autism spectrum disorder (ASD) and pursue CNS benefit via peripheral gut-microbiome mechanisms. The PD program identified a pathway that induces motor and GI symptoms and brain pathology in a validated preclinical PD model and includes AB-4166 (being evaluated for safety and tolerability in a PD subpopulation) and multiple novel chemical entities in the AB-4000 series. The ASD program focuses on reducing systemic and brain exposure to problematic microbial metabolites; lead candidate AB-2004 has shown preclinical ability to repair leaky gut and improve ASD-related behaviors and was expected to enter a Phase 1b/2a trial in adolescents in Q1 2019. The company completed a $25 million Series B equity financing to advance its PD and ASD programs and progress clinical development in 2019. Axial is based in Waltham, Massachusetts and Pasadena, California. Axial Biotherapeutics is building a microbiome discovery platform that leverages research linking the gut microbiome to the central nervous system to develop a new class of microbial-targeted biotherapeutics. The company has licensed exclusive, worldwide rights to intellectual property covering a novel class of CNS biotherapeutics from the Mazmanian Laboratory at Caltech. Axial aims to translate those discoveries into a diverse pipeline of therapies for neurological diseases and disorders. Lead indications named in the launch include autism spectrum disorders (ASD) and Parkinson’s Disease. Axial announced a $19.15 million Series A financing to support its program development and platform expansion. The company has appointed David H. Donabedian, Ph.D., as CEO and a board director as it advances toward clinical development.

Led · Series A · Oct 2021

Seraphina Therapeutics develops FA15™ (pentadecanoic acid, C15:0), a proprietary, vegan-friendly powdered ingredient marketed as fatty15, the company's first essential fatty acid supplement. The product is positioned to support cardiometabolic, immune, and liver health and is sold direct-to-consumer via a subscription platform. Seraphina plans to use new capital to expand its recurring DTC subscription business and to develop ingredient opportunities to fortify foods and beverages with C15:0. The company holds exclusive licensing rights to more than 30 U.S. and international patents, including USPTO patent 11,116,740 issued September 14, 2021, and has received GRAS status for FA15™. Early consumer adoption has been strong—Seraphina sold out its initial offering within six weeks—and retention metrics are high (more than 85% of customers renew; average monthly retention above 90%). The company is running a 12-week randomized, double-blind, placebo-controlled clinical trial to evaluate FA15™'s physiological effects. Seraphina Therapeutics developed fatty15, a consumer dietary supplement that delivers the pure fatty acid C15:0, which the company says promotes cellular resilience, enhances mitochondrial function, and activates receptors that regulate immunity, metabolism, mood, sleep and appetite. The C15:0 discovery was led by founders Drs. Eric and Stephanie Venn‑Watson following research that included studies of bottlenose dolphins; independent studies and a large-scale 14-year study of more than 14,000 people are cited linking higher C15:0 levels to better survival and health. Seraphina launched fatty15 as a vegan-, dairy- and gluten-free supplement sold in refillable glass bottles and is also advancing FA15™, a pure powder form of C15:0, as a food ingredient. The company says it continues to study C15:0 as a potential prescription therapeutic for related nutritional deficiencies. Seraphina is a spinout of Epitracker, Inc. and is headquartered in San Diego.

Participated · Series E · Aug 2020

Fractyl Health is developing Revita DMR, an outpatient endoscopic procedure that resurfaces the duodenal mucosa to treat insulin resistance and metabolic disease. Revita DMR has been studied in close to 300 patients and has received FDA Breakthrough Device Designation for T2D patients treated with insulin, as well as a CE mark in the EU. In the U.S. the device is not yet authorized for marketing and is being evaluated under an FDA-approved Investigational Device Exemption study. The company says its discoveries could address other metabolic diseases such as NAFLD/NASH and aim to reduce the global healthcare and economic burden of metabolic disease. Proceeds from the recent financing will support initiation of multiple late-stage clinical studies and accelerate ongoing REVITA-T2Di work to establish Revita DMR as a cornerstone therapy and reduce insulin dependence. Fractyl is based in Lexington, Mass., and recently renamed itself Fractyl Health to reflect its broader mission. Fractyl Laboratories is developing Revita DMR, a same-day, outpatient endoscopic procedure that uses heat to resurface the duodenal mucosa to reset metabolic pathways and address insulin resistance. Clinical data from close to 300 patients at more than 20 centers across three continents have shown durable improvements in type 2 diabetes and fatty liver disease and a favorable safety profile with no long-term adverse events reported. The Revita DMR System received a CE mark in April 2016 and the CE label was expanded in March 2020 to include insulin withdrawal, improvements in NAFLD/NASH in patients with T2D, and improved insulin sensitivity in PCOS. In the United States, Revita is approved for investigational use only by the FDA. Fractyl announced a first close of $55 million in a Series E financing; proceeds will support the Revita T2Di pivotal clinical trial examining glycemic control and insulin requirements, with a primary endpoint of percentage of patients achieving HbA1c ≤7% without insulin at 24 weeks versus sham. The company plans to initiate its pivotal U.S. trial later this year and use the financing to advance its regulatory and development activities for metabolic disease indications. Fractyl Labs develops Revita Duodenal Mucosal Resurfacing (DMR), an outpatient procedure intended to rejuvenate the duodenum and improve insulin sensitivity in people with type 2 diabetes. The company reports that a one-time Revita DMR treatment yields insulin-sensitizing effects and durable improvements in hepatic and glycemic indices over a year without intensive lifestyle changes. Fractyl plans to use the new funding to continue development of its Revita DMR technology and to support an ongoing Revita-2 multi-center clinical study, which began enrolling patients in Europe in May. Last year the Revita DMR System received a CE mark in the European Union. The company aims to submit an investigational device application with the U.S. Food and Drug Administration to enable investigational use in the United States. Fractyl recently raised $44 million in a Series D financing from multiple venture firms to advance these efforts. Fractyl Laboratories develops the Revita Duodenal Mucosal Resurfacing (DMR) system, a same-day, minimally invasive procedure intended to improve metabolic health in patients with type 2 diabetes. The approach is based on bariatric surgery procedures and aims to produce meaningful improvements in blood sugar and potentially reduce the need for additional medications. The company reported results from a 39-patient, single-site proof-of-concept study showing significant, beneficial changes in blood sugar and has treated 28 patients in its first international multicenter clinical trial. A multicenter Revita-1 trial is currently underway in Europe and South America, and Fractyl plans to begin randomized studies next year. Fractyl recently completed a $57M Series C extension to support and accelerate its clinical development and path to market. The company is headquartered in Waltham, MA, and its Revita system remains for investigational use only while trials continue. Fractyl Labs is developing Revita DMR, a non-invasive duodenal mucosal resurfacing procedure intended to alter the inner surface of the duodenum to change how the body absorbs sugar. The company says the procedure can potentially delay the need for insulin injections in patients with type 2 diabetes. Fractyl reported positive clinical data from a single-site study in Santiago, Chile showing a greater than two percentage-point drop in hemoglobin A1C at three months in 19 of 30 patients, with those 19 maintaining the same blood sugar level at six months. The effectiveness appeared dose-dependent: shorter treated segments produced smaller benefits. Fractyl is preparing to launch a multinational study by the end of 2014 and expects to start U.S. clinical development in 2016. The company is based in Waltham, Massachusetts, and is led by CEO and founder Dr. Harith Rajagopalan.