The following was provided while participating in the 2023 Destination Startup® Showcase.
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What We Do
RaeSedo, a spin-out of the University of Arizona, is developing novel therapeutics for asthma based on an understanding of lung pathology.
Affiliated Institution: University of Arizona
Have we formed a company? Yes
Funding: Grant Funding, Angel Funding (including Self or Friends/Family)
Our Company and the Problem We Are Trying To Solve
Asthma is the most common respiratory disease globally affecting 10% of the world’s population and accounts for 400,000 deaths/year. Exacerbations in more severe asthmatics are of particular concern, as hospitalizations for acute exacerbations account for one-third of the $81.9 billion dollars spent annually on asthma-related health care in the US. In addition, exacerbations in this cohort are associated with accelerated loss of lung function. Unfortunately, asthma remains uncontrolled in more than half of patients receiving current medications. The newest class of asthma therapies, the biologics, target specific inflammatory pathways, are generally reserved for the most severe asthma patients, and are very expensive ($20K-$50K/year). Thus, there is a critical need in the asthma space for a non-corticosteroid-based treatment that is efficacious with fewer side effects than corticosteroids across the spectrum of mild-to-severe asthma. Our objective is to leverage the recently discovered anti-inflammatory effects of a naturally occurring protein produced in the lung, surfactant protein A (SP-A), as a treatment for asthma. We have discovered that small SP-A-derived peptidomimetics demonstrate anti-inflammatory effects relevant to asthma like that of the entire protein. Such a therapeutic would fill substantial market needs as monotherapy for mild asthma, and as add-on therapy for moderate to severe asthma to improve asthma symptoms and reduce asthma exacerbations. Our technology has patents pending and issued in the US and international filings in October. We are entering into a contract agreement with Lovelace Biomedical to formulate an aerosol and perform dose-ranging and toxicity studies in large animals starting fall, 2022.
Our Go-to-Market Strategy
Asthma, one of the most common diseases in the world, is a persistent and potentially life-threatening condition. Pollution, cigarette smoke, environmental irritants, indoor and outdoor allergens are major causes of asthma attacks or exacerbations. In an increasing number of urban and rural areas, there is a substantial rise in asthma cases due to decreases air quality. The increase in prevalence of asthma across the globe is a major factor driving growth of the global asthma drug market. This market size is predicted to surpass US$37.3 billion by 2030 from US$24.2 billion in 2021, growing at a compound annual growth rate of 5.0% from 2021 to 2028. The major companies in the worldwide asthma drug market include GlaxoSmithKline, Boehringer Ingelheim, Sanofi, Roche, Novartis, Merck, AstraZeneca, Genentech, Novartis and Teva Pharmaceuticals. None are developing therapies that are completely analogous to our approach and all are potential acquirers of RaeSedo, Inc. These companies have focused upon biologics which are monoclonal antibodies targeting specific cells important to asthma such as the eosinophil or IgE. However, there is a steep cost in production of these biologics as they require production by living cell lines. An advantage of our SP-A peptidomimetic is that is can be mass produced by chemical companies and does not need a living cell to produce it, thus reducing the overall costs to consumers. Our go to market strategy is to out-license and or sell this product to one of the big pharma companies at either late preclinical or early clinical development.
How We Will Generate Revenue
Focusing on the primary (initial) commercial profile, which in this case is treatment of asthma with our lead SP-A peptidomimetic, we have identified the regulatory requirements for marketing approval by the FDA and designed an appropriate and efficient clinical trial program strategy for each commercial application, with asthma as the first. This product has the potential to become a first line therapy for mild and moderate asthma and add on-for severe asthma prior to or in combination with biologics. This potential is already of interest to pharma. We intend to partner with pharma at the earliest opportunity, taking into account the cost/benefit equation of early vs later stage relationships. In recent years pharma has aggressively licensed or acquired about half of these external assets in the preclinical stage. For our lead for asthma, the costs and risks are well understood from a historical perspective. We have sufficiently robust data and an understanding of mechanism and commercial applications and have had discussions with potential industry partners and investors to further the goals of the company. We have raised both equity funding (Seed Round) as well as NIH grant funding and we continue to pursue both. The specifics of the financial model will depend on the nature of the partnership, but we anticipate development funding, up-front cash, milestones and participation in the economics of market success. We recently received a notice of award for a Phase 2 NIH STTR grant for $3,400,000
How We Will Benefit From Destination Startup®
This event is a perfect platform for us, having just completed the first tranche of our seed round. We are considering additional investment from both angel and venture investors. We are seeking approximately $1.3 million in additional seed round funding. We believe total funding to get to IND filing will be in the range of $3 million, secured through additional grant and equity funding. Our goal is to remain a lean organization, leveraging our resources through collaborations with industry providers.
RaeSedo, Inc. was established in 2019 by co-founders, Drs. Ledford (CSO) and Kraft (CMO), who have been collaborating for ~15 years and have received ~$10M in funding related to this IP. Dr. Ledford has expertise in basic research and pre-clinical animal modeling of respiratory diseases. Dr. Kraft is a world-renowned physician-scientist specializing in airway disease and severe asthma. They are joined by CEO Mike Sember, with over 40 years of global experience in the pharmaceutical industry, CFO Jody Yarbrough, a finance and accounting professional with 25+ years’ experience in healthcare, board member, Base Horner, member of the Desert Angels, and advisory board members: Drs. Serpil Ezrum, Fernando Martinez and Michael Beers- all leaders in their respective fields of asthma and translational surfactant immunotherapies. We feel that that our strong fundamental data, the complementary skill sets of team members and the expertise of advisors, positions RaeSedo, Inc well for success.