Zavante Therapeutics is a San Diego-based clinical-stage biotechnology company focused on therapeutics for hospitalized patients. Its lead product candidate, ZTI-01, is an injectable antibiotic that treats a broad range of infections including those caused by multi-drug resistant bacteria. The company is led by founder, president and CEO Ted Schroeder. Zavante received a $10M credit facility to support regulatory and commercialization activities. Management intends to use the funds to file a New Drug Application for ZTI-01 with the U.S. FDA in the second half of 2017 and to prepare for commercialization. Zavante is backed by life sciences investors including Aisling Capital, Frazier Healthcare Partners and Longitude Capital. Zavante Therapeutics, based in San Diego, focuses on licensing, developing and commercializing novel products that address serious unmet medical needs in the hospital setting. Its lead candidate, ZTI-01 (fosfomycin for injection), is an injectable epoxide antibiotic with broad-spectrum bactericidal activity against gram-negative and gram-positive bacteria, including many contemporary multidrug-resistant strains. ZTI-01 has received FDA Qualified Infectious Disease Product (QIDP) designation for complicated urinary tract infections, and the QIDP designation was later expanded to include complicated intra-abdominal infections, hospital-acquired/ventilator-associated bacterial pneumonia, and acute bacterial skin and skin structure infections. The company plans to use the recently raised funds to develop ZTI-01 and to initiate the ZEUS single pivotal clinical trial in the second quarter of 2016. Led by founder, president and CEO Ted Schroeder, Zavante is advancing ZTI-01 through pivotal clinical development for hospital use. Financially, the company closed a $45M financing that combines new investor capital and note conversion. Zavante Therapeutics is a San Diego biopharma startup developing ZTI-01, an injectable antibiotic intended primarily for complicated urinary tract infections. The company says ZTI-01 is novel, has both Gram-positive and Gram-negative activity, and is showing efficacy against Carbapenem Resistant Enterobacteriaceae (CRE). ZTI-01 received Fast Track status from the FDA for three other indications while UTIs remain the primary focus. The drug previously received QIDP designation in September 2014 for cUTI and in December 2015 those QIDP designations were expanded to include cIAI, HABP/VABP, and ABSSSI, which could enable priority review and a five-year market exclusivity extension under the GAIN Act. With a new $10 million equity round, Zavante will begin clinical trials next quarter to evaluate ZTI-01 versus piperacillin-tazobactam in hospitalized adults with UTIs, including acute pyelonephritis. The company and the article emphasize the urgent need for new antibiotics given rising bacterial resistance, citing a recent CRE infection incident tied to reusable duodenoscopes as an example.

Total raised

$65M

Funding rounds

3

Latest round

Debt Financing

Latest activity

Sep 2016