The Venture Codex

Participated · Series D · May 2014

Proteon Therapeutics' lead product, PRT-201, is an investigational recombinant human elastase being developed to prolong patency and reduce failure of hemodialysis vascular access in patients with chronic kidney disease. Preclinical data suggest elastase can reduce neointimal hyperplasia and dilate segments of arteries and veins, which may improve blood flow and vessel patency. PRT-201 has received FDA fast track and orphan drug designations and an orphan medicinal product designation from the European Commission for hemodialysis vascular access indications. The company plans to initiate a Phase 3 study later this year to evaluate PRT-201 in patients undergoing surgical placement of an arteriovenous fistula (AVF). Proteon is headquartered in Waltham, Mass. The company concurrently raised financing to support its late-stage development program. Proteon Therapeutics is a privately held biopharmaceutical company based in Waltham, MA developing novel, first-in-class pharmaceuticals to address medical needs in renal and vascular diseases. Its lead candidate, PRT-201, is a locally-acting recombinant human elastase that fragments elastin fibers in blood vessel walls. Proteon is investigating whether elastase can be used to dilate arteries and veins and reduce neointimal hyperplasia where those effects would provide clinical benefit. The company is initially evaluating PRT-201 to improve outcomes associated with the surgical creation of vascular accesses in chronic kidney disease patients undergoing hemodialysis. PRT-201 has received FDA fast track and orphan drug designations for hemodialysis vascular access indications. Proteon recently completed a $15.2M financing, and lists a number of institutional and angel investors among its backers.

Participated · Series D · Mar 2014

ZS Pharma is a privately held specialty pharmaceutical company based in Coppell, Texas, developing novel treatments for kidney, cardiovascular and liver disorders. Its lead product candidate, ZS-9, is a novel investigational treatment for hyperkalemia being evaluated in late-stage clinical trials to remove excess potassium and maintain normal potassium levels. The company recently completed a 753-patient Phase 3 study showing ZS-9 rapidly reduced serum potassium to normal within 48 hours and maintained potassium with once-daily dosing, with an adverse event profile similar to placebo. ZS Pharma plans to initiate two additional studies in 2014 and intends to file an NDA with the FDA and an MAA with the EMA in early 2015. The company is also pursuing additional drug candidates that utilize its selective ion-trap technology for kidney and liver diseases. Proceeds from the recent financing will be used to advance ZS-9 through NDA and MAA submissions. ZS Pharma develops ZS-9, a crystal form of zirconium silicate designed to remove life-threatening toxins from patients with kidney and liver disease. Initial human clinical testing targeted patients with elevated blood potassium (hyperkalemia). The company intends to advance ZS-9 through pivotal trials and prepare for commercialization. It also plans to research and develop additional compounds targeting kidney and liver conditions with limited treatment options. ZS Pharma is led by president and CEO Dr. Al Guillem and is based in Fort Worth, Texas. The company closed a $46M financing to fund development and pivotal trials.

Participated · Equity · Sep 2013

Inotek Pharmaceuticals is focused on developing innovative drugs for eye diseases with a major emphasis on glaucoma; its lead candidate is trabodenoson, a drop‑administered drug currently in Phase 2. Trabodenoson is designed to increase aqueous humor outflow through the eye’s trabecular meshwork, a mechanism differentiated from existing prostaglandins and other approved therapies. Preclinical work and mechanistic studies indicate the drug up‑regulates proteases in the trabecular meshwork to clear proteinaceous blockages and restore outflow. A recently completed multi‑dose Phase 2 monotherapy study showed significant IOP reduction in the range of market‑leading prostaglandins such as latanoprost, and the drug was reported to be safe and well tolerated. Inotek plans to initiate a Phase 2 study later this year to evaluate trabodenoson in combination with latanoprost for patients inadequately controlled on latanoprost alone. Financially, the company closed a $21 million equity financing and concurrently secured $7 million in venture debt to advance ongoing clinical development; the company is located in Lexington, MA. Inotek Pharmaceuticals is a Lexington, Massachusetts-based developer of innovative drug candidates to address significant diseases of the eye. Its lead program is INO-8875, an investigational eye-drop for glaucoma. In an earlier Phase 1/2 trial, INO-8875 was shown to significantly reduce intraocular pressure in glaucoma patients. The company plans to advance INO-8875 into multiple-dose Phase 2 clinical trials. To support that work it closed an $18M preferred stock financing. As part of the round, John Leaman joined Inotek’s board of directors.

Participated · Series B · Aug 2013

MicuRx Pharmaceuticals is a privately-held biopharmaceutical company based in Hayward, California and Shanghai that discovers and develops antibiotics with improved safety profiles. Its lead compounds are contezolid (MRX-1), an oral oxazolidinone targeting MRSA, and contezolid acefosamil (MRX-4). Contezolid completed two independent Phase 2 studies in the US and China in 2015 and is nearing completion of a Phase 3 program in China for complicated skin and skin structure infections (cSSSI). The company said MRX-4's Phase 2 study in the USA was expected to start in 2018. MicuRx intends to use the new financing to complete the ongoing Phase 3 program for contezolid (MRX-1), pursue a projected Chinese NDA filing, and support other business activities in China. The company has research and development facilities outside San Francisco and in Shanghai and is led by president and CEO Zhengyu Yuan, Ph.D., and CMO Barry Hafkin, M.D. As of the article, MicuRx has raised a total of $107m from venture capital firms. MicuRx is advancing MRX-I, an oral next-generation oxazolidinone antibacterial for infections caused by multi-drug resistant Gram-positive bacteria, including MRSA and VRE. The company completed Phase 1 trials in China and Australia and Phase 2 trials of cSSSI in China and ABSSSI in the U.S. in 2015, using linezolid as a comparator. Those studies demonstrated MRX-I's non-inferiority to linezolid and showed evidence of reduced hematologic toxicity relative to linezolid. MicuRx plans to use the Series C proceeds to continue development of MRX-I in both the United States and China, including completing a Phase 3 trial in China for oral MRX-I in complicated skin and skin structure infections (cSSSI). It also intends to complete a pivotal U.S. Phase 3 trial with oral and intravenous formulations for acute bacterial skin and skin structure infections (ABSSSI) and to file a Chinese NDA for cSSSI. Zhengyu Yuan, Ph.D., serves as president and CEO. MicuRx Pharmaceuticals is a Hayward, CA-based biopharmaceutical company developing novel antibiotics to combat infections due to resistant bacteria. Its lead program is MRX-I, a novel oral oxazolidinone antibiotic targeting multi-drug resistant Gram-positive bacteria, including MRSA and VRE. The company intends to use the new capital to fund U.S. development of MRX-I. MicuRx is led by Zhengyu Yuan, Ph.D., president and chief executive officer. It maintains research and development facilities in Hayward, CA and Shanghai, China. To date the company has raised $37M in total funding. MicuRx Pharmaceuticals develops new small‑molecule anti‑infective drugs. The company positions itself as a US–China hybrid, combining biotech pharma innovation in the U.S. with enterprise‑friendly infrastructure and scientific resources in China, and lists R&D bases in the San Francisco Bay Area and Shanghai Zhangjiang Science Park. It appears to be starting by attempting to in‑license failed or abandoned drug candidates from larger pharmaceutical companies. The company was founded by two former officials at Vicuron Pharmaceuticals; the co‑founders named in the article are Zhengyu Yuan and Mike Gordeev, who have Chinese and Russian backgrounds respectively. Financially, MicuRx raised $10 million in a first round of funding. The articles note the firm may not do much of its fundraising or scientific and clinical work in the U.S.

Participated · Series B · May 2013

Cardeas Pharma is a Seattle, WA-based biopharmaceutical company developing inhaled antibiotics to treat serious, hospital-acquired respiratory infections caused by highly antibiotic-resistant organisms. Led by CEO Bruce Montgomery, the company is advancing an investigational amikacin/fosfomycin inhalation solution delivered via the eFlow® InLine Nebulizer system. Cardeas partners with PARI Pharma GmbH, which is studying its proprietary eFlow InLine Nebulizer for administration in mechanically ventilated patients. The company completed a $34M Series B financing to fund clinical development. Cardeas intends to use the proceeds to support Phase 2 development of its lead compound as a potential treatment for healthcare-associated pneumonia in patients on mechanical ventilation.