Business Model: Aqualung Therapeutics plans on completing Phase I safety clinical trials in 2019 and Phase II trials in the ICU to be completed in 2021. Prior to Phase III trials, we seek to be acquired by a large biopharmaceutical company that is looking to expand their drug pipelines and with a desire to enter an untapped market place.
Funding to Date:
- $631,234 NIH NHLBI STTR Phase I, R41HL110707 “PBEF neutralizing humanized monoclonal antibodies as novel therapeutics approaches” 09/01/2011-06/30/2014.
Detailed Use of Proceeds (including timing, milestones, etc):
Antibody production for preclinical studies; conducting pharmacodynamics/pharmacokinetic studies in rats; composition patent filing and attorney fees; utility license fees and milestone payments. (3Q 2017-3Q 2018, $500,000 in convertible notes)
Future Capital Requirements (timing, amounts):
- Series A $1.5M: Toxicology studies in rats and dogs, IND filing and expenses (4Q 2017 – Q3 2018)
- Series B $7.5M: Phase I safety clinical trials on 20 volunteers (2019, $0.5M), Phase II efficacy clinical trials on 100 patients (2020-2021, $7M)
Exit Strategy: ALT seeks to exit after Phase I (early 2020) but before Phase III clinical trials (late 2021), through acquisition by a large biopharmaceutical company that is looking to bolster their drug pipeline. We plan to conduct small (n=20-40) Phase I safety clinical trials in healthy volunteers. We will then conduct Phase II efficacy clinical trials (n=100) in coronary artery bypass graft surgery patients, who have healthy lungs but are placed on mechanical ventilators (monitoring reduction in circulating NAMPT cytokine levels) and in ICU patients that are placed on mechanical ventilation (monitoring the benefit of therapeutic antibody treatment based on days on the ventilator).