• Aerpio Pharmaceuticals

  Participated · Equity · Apr 2014

  Aerpio Therapeutics is a clinical‑stage biopharmaceutical company focused on small‑molecule therapies that activate Tie2 and stabilize HIF‑1α. Its lead program, AKB‑9778, is a first‑in‑class Tie2 activator currently in a randomized Phase 2 trial for diabetic macular edema (DME). The Phase 2 study is testing AKB‑9778 as monotherapy and as an adjunct to ranibizumab with primary endpoints of change in visual acuity and central retinal thickness. Aerpio is also advancing AKB‑4924, a HIF1 activator, toward clinical development for inflammatory bowel disease after robust preclinical activity in models of ulcerative colitis and Crohn’s disease. Proceeds from the recent financing will support expanded development of AKB‑9778 and progression of AKB‑4924 into the clinic. The company announced the financing from Cincinnati and expects to initiate development in a second target indication before year end. Aerpio Therapeutics is focused on developing Tie2-activating small molecules, with lead candidate AKB-9778 targeting diabetic macular edema (DME). AKB-9778 inhibits human protein tyrosine phosphatase β (HPTPβ) to restore Tie2 signaling, stabilizing retinal blood vessels to reduce edema and vascular leak. A 28-day Phase 1b/2a ascending-dose study in 24 DME patients showed AKB-9778 was well tolerated and produced meaningful changes in retinal thickness and vision gain in some treated patients. The company plans an expanded clinical program, including a Phase 2 study to confirm monotherapy efficacy and to explore adjunctive use with a VEGF inhibitor; a Phase 2 was expected to begin early in 2014. Financially, Aerpio completed a $9 million extension to its $27 million Series A from 2012 to support ongoing development. The company announced corporate activity including investor participation and a board change tied to the financing. Aerpio Therapeutics is a clinical-stage biopharmaceutical company focused on developing therapies that stabilize vasculature via Tie2 activation and HIF-1α stabilization. The company's lead candidate, AKB-9778, is a first-in-class small molecule that inhibits HPTPβ to restore Tie2 signaling. AKB-9778 showed tolerability and on-target pharmacology in a Phase 1 healthy volunteer study and is entering a Phase 1b/2a trial for diabetic macular edema (DME). Aerpio plans a large, definitive Phase 2 study in DME patients following completion of the Phase 1b/2a study. The company cites potential utility of Tie2 activators in age-related macular degeneration and retinal vein occlusion but is currently focused on DME. Aerpio was created in a spin-out transaction from Akebia Therapeutics in December 2011 and is based in Cincinnati.

• ViewRay

  Participated · Equity · Dec 2013

  ViewRay is a Cleveland, Ohio-based medical device company developing advanced radiation therapy technology for the treatment of cancer. Its MRIdian system provides continuous soft-tissue imaging during treatment, using MRI-guided radiation therapy so clinicians can see where the actual radiation dose is being delivered and adapt to changes in the patient’s anatomy. Led by president and CEO Chris A. Raanes, the company intends to accelerate worldwide commercialization of the MRIdian system. To support that expansion and optimize its capital structure, ViewRay secured up to $50 million in debt financing from CRG (formerly Capital Royalty L.P.). The financing will initially provide $30 million of interest-only debt for three years, and the company has the option to draw an additional $20 million upon achieving certain milestones. Proceeds will also be used to retire $13 million of debt with less favorable terms. ViewRay develops an MRI-guided radiotherapy system that provides continuous soft-tissue imaging during treatment, enabling clinicians to see the cancer target, monitor delivered radiation dose, and adapt to anatomical changes in real time. Led by president and CEO Chris A. Raanes, the company is commercializing the ViewRay system globally. The system had been acquired by five cancer treatment centers worldwide at the time of the report. ViewRay secured $30M in funding to support worldwide commercialization efforts. Funding included participation from existing equity investors and a new strategic investor, plus debt financing to support the company’s growth. ViewRay develops advanced radiation therapy technology for the treatment of cancer, offering systems that provide continuous soft-tissue imaging during treatment. Its platform enables physicians to better control the delivery of radiation therapy prescriptions through real-time soft-tissue imaging. The company was founded in 2004 and is based in Cleveland, Ohio. Leadership named in the article includes President and CEO Chris A. Raanes, Chief Scientific Officer James F. Dempsey, PhD, and Chief Medical Officer Prabhakar Tripuraneni, MD. As of May 2013 ViewRay raised $15m in funding; investors were not named. Prior financings recorded by FinSMEs include $20m in 2010 and $45m in 2012. ViewRay Inc., based in Cleveland, Ohio, develops image-guided radiation therapy technology that uses MRI to provide continuous soft-tissue imaging during treatment. Its system is designed to let clinicians see where the actual radiation dose is being delivered and adapt to changes in the patient’s anatomy. The company’s treatment planning and delivery software received 510(k) premarket notification clearance from the U.S. FDA in 2011, and its integrated imaging and radiotherapy delivery system is pending 510(k) review. ViewRay intends to use new funding to prepare for market launch. The first research system is undergoing final installation at the Siteman Cancer Center at Barnes‑Jewish Hospital and Washington University School of Medicine in St. Louis. The company is led by President and CEO Gregory M. Ayers, MD, PhD. ViewRay develops MRI-based radiotherapy technology that provides continuous soft-tissue imaging to enable more accurate delivery of radiation and reduce exposure to healthy tissue. Its system lets clinicians see where radiation is being delivered in real time, addressing internal organ motion that can misdirect treatment. In February the company received U.S. regulatory clearance for its treatment planning and delivery software, while clearance for its integrated system is still pending; the integrated system is currently limited to nonhuman research. In March the University of Wisconsin Carbone Cancer Center acquired ViewRay’s radiotherapy system for research use. Financially, ViewRay recently secured new funding via convertible notes to support commercialization efforts while it awaits full system clearance. The company relocated to Oakwood Village, Ohio in 2008 and received state job-creation tax credits tied to that move.

• TriVascular

  Participated · Series E · Nov 2013

  TriVascular develops design and manufacturing technologies for endovascular aortic repair (EVAR), including the Ovation and Ovation Prime implant platforms. The Ovation system received U.S. FDA PMA approval in October 2012 and CE Mark clearance in August 2010. Its products are approved for sale in over 30 countries, with approximately 2,700 patients treated to date. The company is led by Chairman and CEO Christopher G. Chavez. TriVascular closed a $40M Series E equity financing to expand commercial efforts worldwide and to accelerate its product pipeline and clinical research activities. Backers for the round include both existing and new investors as detailed below. TriVascular develops devices for endovascular aortic repair, including the Ovation Abdominal Stent Graft System. The company is pursuing U.S. PMA approval for Ovation and plans to use funding to initiate U.S. commercial activity. It also intends to drive further international sales expansion and continue product development. TriVascular is led by Chairman and CEO Christopher G. Chavez and is based in Santa Rosa, California. The company recently closed the initial tranche of a Series D equity financing to support these efforts. TriVascular, Inc., based in Santa Rosa, California, develops endovascular aortic repair (EVAR) stent graft systems. Its lead product is the Ovation Abdominal Stent Graft System, an investigational device designed to expand the patient population suitable for EVAR by addressing a wider range of diseased anatomy. The company is also advancing the Ovation Thoracic Stent Graft System. Clinical activity includes a completed study in Germany and a pivotal study underway in the United States, with research efforts spanning three continents. TriVascular plans to use the new capital to launch the Ovation abdominal system in Europe, drive clinical research globally, and accelerate next-generation product development. The company closed $60M in funding comprising a Series C equity financing and growth-capital venture debt, following a $30M Series B raised in November 2009. As part of the financing, David J. Kim of Pinnacle Ventures and Ryan Drant of NEA will join the board. TriVascular, based in Santa Rosa, California, develops innovative products for the treatment of cardiovascular disease. The company raised $30m in a Series B financing. The funds will be used to invest in TriVascular’s operations in Sonoma County and to build the infrastructure necessary to support clinical activity on four continents. TriVascular has over 170 employees in Santa Rosa. Investors in the round included New Enterprise Associates, Delphi Ventures, MPM Capital and Kearny Venture Partners.

• Boreal Genomics

  Participated · Series C · Oct 2013

  Boreal Genomics provides a platform that performs sensitive genomic analysis of cell-free DNA in plasma to detect and quantify mutations in tumor-derived circulating nucleic acids. The company offers its assay through both service and instrument offerings for research use only and expects the test will soon be certified for use in clinical studies. Boreal intends to use new financing to expand commercial operations in the translational research market, enhance laboratory capabilities and launch clinical applications for non-invasive genomic profiling and cancer monitoring. The company is expanding Bay Area facilities, including laboratory and commercial operations at a new location in Mountain View, California, and maintains a research and development site in Vancouver, British Columbia. Boreal is led by CEO Nitin Sood.

• Akebia Therapeutics

  Participated · Series C · Jun 2013

  Akebia Therapeutics is a fully integrated biopharmaceutical company focused on developing vadadustat, an investigational therapy for anemia in patients on dialysis. The company says vadadustat is under FDA review, with a potential decision noted for March 27, 2024. Akebia secured a $55 million term loan facility to strengthen liquidity around that regulatory milestone. The arrangement provides $37.0 million immediately and an additional $18.0 million contingent on FDA approval of vadadustat. The financing includes an extended interest-only period and deferred principal repayment, which reduces near-term cash outflows. Management frames the facility as enabling the company to navigate pre- and post-approval activities, including potential commercialization efforts. The deal increases financial leverage and creates eventual repayment obligations tied to the company’s future regulatory and commercial outcomes. Akebia Therapeutics is developing AKB-6548, an orally available hypoxia‑inducible factor prolyl hydroxylase (HIF‑PH) inhibitor intended to treat anemias secondary to chronic kidney disease (CKD) and end‑stage renal disease. The compound is positioned as a potentially safer, orally dosed alternative to injectable erythropoiesis stimulating agents (ESAs) by stimulating endogenous EPO via HIF2α stabilization. In a 93‑patient, 42‑day Phase 2a CKD trial AKB-6548 produced a statistically significant, dose‑related increase in hemoglobin with a safety profile comparable to placebo and low iron requirements. Akebia plans a 140‑day Phase 2b CKD trial expected to begin in the third quarter and intends to use new financing over the next 18 months to complete studies and prepare AKB-6548 for Phase 3. The company was spun out of Procter & Gamble Pharmaceuticals in 2007 and is based in Cincinnati, Ohio. No revenue or user metrics were disclosed in the article. Akebia Therapeutics is a discovery and development company focused on treatments for chronic anemia. Its lead program, AKB-6548, is an orally bioavailable HIF-prolyl hydroxylase (HIF-PH) inhibitor currently in Phase 2 clinical trials. AKB-6548 is described as potentially best-in-class, offering potential advantages including an improved safety profile, once-daily oral dosing, and lower cost of goods versus traditional erythropoiesis stimulating agents. The company drew down a $4.1 million tranche of a previously announced Series B financing to enable completion of the Phase 2 study and to continue the process of selecting a partner for Phase 3 pivotal studies. The tranche was provided by a syndicate of life-science investors. Separately, Akebia spun out two programs—AKB-9778 (Tie-2 activator) and AKB-4924 (HIF-1α stabilizer)—to form a new stand-alone company, Aerpio Therapeutics. Akebia Therapeutics is a Cincinnati, OH–based pharmaceutical discovery and development company focused on anemia and vascular disorders. Its lead anemia program is AKB-6548, which the company says offers potential advantages over traditional erythropoiesis-stimulating agents, including an improved safety profile, oral dosing and lower cost of goods. The financing announced enables Akebia to complete two Phase 2b studies of AKB-6548 and to position that program for pivotal studies. Akebia also plans to advance AKB-9778, a novel Tie-2 activator for diabetic macular edema and vascular leak, into the clinic. The company closed a $22m Series B with a $14m first closing and the right to access an additional $8m through the end of 2011, which funds these near-term clinical plans. Akebia Therapeutics was formed by Joseph Gardner and John Rice to commercialize therapies acquired from Procter & Gamble and focuses on small-molecule drug discovery and development. Its lead candidate is AKB-6548, an oral erythropoietin-stimulating drug intended to treat chronic anemia. The company reported positive Phase 1 results in 33 healthy volunteers, showing increased erythropoietin and reticulocytes and good tolerability. Akebia plans to move into Phase 2 clinical trials for AKB-6548 and is evaluating partnering with a large pharmaceutical company or pursuing additional fundraising to complete development. Financially, the company recently completed a second closing that boosted a previously announced financing to $17 million. Management expects market opportunities due to safety concerns with existing injectable ESAs and potential expansion of the treated patient population if oral agents prove safer and easier to use.

No current team members are available.