The following was provided while participating in the 2023 Destination Startup® Showcase.
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What We Do
An immunotherapy company focused on developing therapeutics for diseases of unchecked inflammation and fibrosis.
Affiliated Institution: University of Arizona
Have we formed a company? Yes
Funding: Grant Funding, Angel Funding (including Self or Friends/Family), Venture Capital
Our Company and the Problem We Are Trying To Solve
There are currently NO FDA approved therapies for the condition of Acute Respiratory Distress Syndrome (ARDS) and the mortality rate is reaching 40%. Aqualung Therapeutics scientists identified a novel upstream protein (eNAMPT) which is a master regulator of inflammation and fibrosis. In fact, when an ARDS patient is put on a ventilator in the ICU the number one protein expressed is eNAMPT and it increases in the blood stream 3-10 fold. This leads to runaway inflammation and the cytokine storm. Aqualung has a novel antibody mAb (ALT-100) which binds to eNAMPT and thereby attenuates the cytokine storm and dramatically mitigates inflammation. In fact, in both small and large animal models, ALT-100 improved lung function by greater than 50% in a sepsis induced porcine model, and also reduced inflammatory markers greater than 50% in the same model. This most replicates the human study expected results and will lead to less days on the vent, less days in the ICU, less days in the hospital and a mortality benefit. We have over 3500 doses of cGMP material. We have an IND from the FDA (22 Sept 2022) and we have already dosed 2 cohorts in our healthy human volunteer study in Australia. This is highly derisked. We need more money for our series A to augment the $3M comittment we have for the series A which we will close within 30 days. Raising a total of $10M and the terms for the series are set.
Our Go-to-Market Strategy
Since this is years from being approved by the FDA. The goal is to license this to a big pharma company who is looking for an anti inflammatory and anti fibrotic agent. They want a novel target with both properties in their immunology divisions and we are the worlds leader in eNAMPT targeting and we also own the IP. This will be licenced within 24-36 months.
How We Will Generate Revenue
We are an early stage biotech company so generating revenue is not in our near term model. If an investor is looking for a 5-10X return on investment within 24-20 months this is the investment. We are already in discussions with big pharma as we have had many meetings with them regarding the fibrosis indications. We need $10M to complete the P2A ARDS study and also submit our chronic IND package to the FDA with the sub Q formulation and the chronic tox package. (tox package paid by NIH grants)
How We Will Benefit From Destination Startup®
Seeking both venture and corporate capital. We want to round out our series A with the lead institutional investor (JSR lifescieces) and then have a licensing agreement with the likes of big pharma who are already in discussions with us. It is our hope that you will have some institutional health care investors who are looking for a de-risked asset and also some high net worth individuals who are seeking the next humira type of therapy that has the ability to treat multiple indications outside of just ARDS.
Our Team
Joe GN Garcia. MD CEO and Founder. World renowned physician scientist who is in the national academy of medicine. Published over 600 papers and is a world leader in ARDS. Former head of critical care medicine at Johns Hopkins, ran the health systems of Univ of Chicago, Univ of Iliinois and also Univ of Arizona. Stan Miele: President and CBO Over 35 years in life sciences. Former President of Sucampo Pharma Americas and has years of drug and device development and commercialization under his belt. Launched numerous drugs and devices in the US and internationally. Executed numerous global licensing deals.