Led · Equity · Aug 2019

Cleave Therapeutics is advancing therapies that target valosin-containing protein (VCP/p97) to modulate protein homeostasis and stress pathways in cancer and neurodegeneration. Its lead candidate, CB-5339, is a potent, oral, selective, second‑generation VCP/p97 inhibitor described as IND‑ready and designed to address exposure and selectivity limitations of earlier compounds. The company is initiating a Phase 1 clinical study in acute myeloid leukemia (AML). The National Cancer Institute plans to sponsor a Phase 1 trial of CB-5339 in solid tumors in collaboration with Cleave. Cleave announced the closing of a $12 million equity financing to advance CB-5339 through early clinical development. The company also announced executive appointments including Amy Burroughs as CEO, Scott Harris as COO, and Laura Shawver as board chair. Cleave Biosciences develops drugs that target protein homeostasis, with a lead program CB-5083—an oral inhibitor of p97—aimed at treating a range of solid tumors and hematologic malignancies. CB-5083 is being evaluated in two Phase 1 trials: CLC-101 for patients with solid tumors and CLC-102 for patients with lymphoid hematologic malignancies including multiple myeloma. The program has received Orphan Drug Designation from the U.S. FDA for multiple myeloma. The company intends to use the Series B proceeds to advance clinical development of CB-5083 and to support discovery efforts around its AAA ATPase platform. Laura Shawver, Ph.D., serves as CEO and the company is based in Burlingame, California. Cleave Biosciences discovers small-molecule drugs that modulate protein degradation pathways, with a lead program targeting p97, a central player in the ubiquitin–proteasome and autophagy systems. The company is led by CEO Laura Shawver, Ph.D. Cleave plans to use new capital to move its lead program into clinical trials and to advance a second discovery program. Financially, the company has been funded through venture rounds and this financing increased its Series A to $54M. In 2011 Cleave raised $44M from investors including US Venture Partners, 5AM Ventures, Clarus Ventures, OrbiMed Advisors, Astellas Venture Management and Osage University Partners. The recent financing also added New Enterprise Associates as an investor and included a board appointment. Cleave Biosciences is a newly established biopharmaceutical company based in Burlingame, California, focused on discovering and developing novel cancer therapies directed at protein homeostasis. Its current programs are small-molecule discovery and development efforts that are undergoing lead identification and optimization. The company plans to use the Series A proceeds to support multiple discovery and development programs in this area. Cleave was co-founded by Raymond Deshaies, Seth Cohen and Francesco Parlati. Its management team includes CEO Laura Shawver and President and CSO Mark Rolfe. In conjunction with the financing, several investors and company leadership will join the board.

Participated · Series C · Jul 2017

Exosome Diagnostics develops and commercializes exosome‑based, biofluid diagnostics using its ExoLution™ platform and point‑of‑care instrumentation ShahkyTM. Its flagship offering is the ExoDx® Prostate (IntelliScore) test, and the company is commercializing additional oncology diagnostic tests. Management plans to expand into other areas including neurodegenerative diseases, transplant rejection monitoring, and cardiology. Exosome Diagnostics is building out a companion diagnostics (CDx) business and expanding placement of exosomal instrumentation while advancing point‑of‑care clinical development. Technology differentiators cited include one‑reaction RNA and cell‑free DNA interrogation for signal enhancement and the ability to isolate disease‑specific exosomes by tissue type. The company completed a $30 million Series C financing to support rapid commercial expansion and further commercialization of its technologies. Exosome Diagnostics develops an exosome-based liquid biopsy platform that isolates and analyzes exosomal RNA, DNA and proteins from biofluids to enable non-invasive molecular diagnostics. The company’s tests analyze exoRNA for cancer biomarkers and its platform can simultaneously interrogate exoRNA and cell-free DNA to enhance detection of rare mutations. Exosome Diagnostics also highlights protein biomarker interrogation capabilities to broaden its diagnostic scope. The company plans to launch combined RNA-plus-DNA commercial liquid biopsy tests and pursue potential companion-diagnostic programs with pharma. It intends to expand development beyond oncology into areas such as neurodegenerative, inflammatory, metabolic, and cardiovascular diseases. Financially, Exosome Diagnostics completed a $60 million Series B financing to support growth of its commercial diagnostics, regulatory, and companion-diagnostics divisions and to advance new test and biomarker development. Exosome Diagnostics develops exosome-based molecular diagnostics that isolate and analyze exosomal RNA (exoRNA) and can also analyze cell-free DNA (cfDNA) from biofluids such as plasma, urine and saliva. Its liquid biopsy tests analyze exoRNA for cancer biomarkers and the platform is positioned to be applied to non-oncology indications as well. The company announced a $17.6M extension of its Series B, bringing the total Series B financing to $44.7M, and said the funds will support commercial and development efforts. Planned near-term commercial launches in 2015 include two blood-based lung cancer liquid biopsies (detecting ALK and T790M mutations), a urine-based prostate cancer liquid biopsy, and a 26-gene solid tumor panel offered initially as an LDT. It is developing a next-generation solid tumor panel planned for 2016 to detect 88 genes and thousands of mutations, and is beginning early development of diagnostics for neurodegenerative diseases. Management says the financing positions the company to transition to a commercial-stage company and expand its exosome-based tests across additional disease areas. Exosome Diagnostics develops fluid-based molecular diagnostic tests that analyze exosomes and other microvesicles in biofluids (blood, urine, cerebrospinal fluid) to detect disease-specific genetic material. Led by CEO James McCullough, the company positions its platform for personalized medicine and oncology applications. Planned near-term product launches include EXO106 (a prostate-cancer diagnostic to reduce unnecessary biopsies) and exoRNeasy research kits for RNA extraction targeted for Q2 2014. Under an expanded collaboration with QIAGEN the company is developing EXO501, a blood-based test to measure an actionable mutation in non-small cell lung cancer for non-invasive, repeated tumor mutation assessment. It is also developing EXO1000, a blood-based multi-gene clinically actionable biomarker panel for oncology. The company will use the new funding to support these product launches and continued R&D of its proprietary technology platform. Exosome Diagnostics develops exosome-based molecular diagnostics that detect cancer-specific genes from standard blood and urine samples. Its proprietary exosome technology enables minimally invasive testing for disease stratification and monitoring patient response to treatment. The company aims to further develop and commercialize a series of body-fluid-based oncology diagnostics using the new capital. Exosome Diagnostics is establishing R&D and service operations in New York and Munich to support development and commercialization. In conjunction with the financing it incorporated Exosome Diagnostics GmbH as a wholly owned subsidiary to serve as the European center for development and services. The company raised $20M in equity funding to advance these efforts.

Participated · Series A · Jun 2015

XTuit develops a novel class of microenvironment‑activated drugs intended to reverse fibrosis and enhance anti‑tumor efficacy by targeting hypoxia, extracellular matrix accumulation, and activated stromal cells. The company’s lead programs comprise two series being advanced toward early clinical proof‑of‑concept in liver diseases (including liver cirrhosis and NASH) and oncology. Proceeds from the recent financing will be used to move the lead products into the clinic and to build a quantitative, tissue‑based biomarker platform to enable rapid proof‑of‑concept and efficacy prediction. XTuit’s agents have single‑agent, disease‑reversing activity in fibrotic inflammatory conditions and show synergistic activity with standard‑of‑care cancer therapies, including immune checkpoint inhibitors, chemotherapy, and targeted agents. The company emphasizes biomarker‑accelerated clinical development to demonstrate improved outcomes and to overcome stroma‑induced treatment resistance. XTuit is backed by several institutional life‑science investors and lists noted scientific founders who helped elucidate the underlying microenvironment mechanisms. XTuit Pharmaceuticals is a Harvard spinout focused on developing therapeutics that manipulate the tumor microenvironment, particularly tumor vasculature and extracellular matrix, to improve delivery and efficacy of therapies. The company’s scientific direction is grounded in founder Rakesh Jain’s work on vascular normalization, biomarkers of tumor escape, and strategies to extend the normalization window. Other research areas include engineering long-lasting blood vessels (including iPS-cell approaches), lymphatic function and lymphangiogenesis, metastasis biology, and drug screening to treat metastasis. XTuit has translated laboratory insights toward regenerative-medicine applications and plans to explore biomarkers for tailoring therapies to individuals. The company joined JLabs’ Kendall Square incubator and has hired Peter Blume Jensen as chief scientific officer. Financially, XTuit is Polaris Partners–backed and has raised multiple financings this year.

Participated · Series B · Sep 2014

Tracon Pharmaceuticals develops targeted therapies for cancer and age-related macular degeneration. Its current pipeline includes two clinical-stage candidates: TRC105, an anti-endoglin antibody being developed for multiple solid tumor types, and TRC102, a small molecule being developed for lung cancer and glioblastoma. The company is led by President and CEO Charles P. Theuer, M.D., Ph.D., and newly named CFO Patricia Bitar. In September 2014 Tracon closed a $27M Series B financing. Investors in the round included New Enterprise Associates, BioMed Ventures, JAFCO Co., Nextech Invest, Brookline Investments, Arcus Ventures and BHP. In conjunction with the funding Paul Walker of NEA joined Tracon’s board and Bruce Steel of BioMed Ventures will serve as a board observer. TRACON is developing TRC105, a monoclonal antibody that inhibits angiogenesis, as its core therapeutic program. The company is advancing TRC105 in multiple Phase 1b and Phase 2 indications supported by the National Cancer Institute, with ongoing trials in prostate, bladder and liver cancers. To fund development, TRACON held a $14M first closing of a planned $22M venture capital financing. The round is intended to continue clinical development of TRC105 across those indications. In conjunction with the financing, representatives from lead investors will join the company’s board. TRACON is led by President and CEO Dr. Charles Theuer and is based in San Diego, CA.

Participated · Series C · Jul 2014

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.