Investment and partnering
Dr John Dennis, CEO
SolAeroMed Inc.’s (“SAMi”) drug candidate S-1226 has been under development by the company’s scientific founders since the early 1990s. Their work into the mechanisms underlying a surge in the western Canadian provinces of asthma-related deaths led to the discovery of a novel therapeutic intervention. Patent applications were filed in December of 2005. A European patent was granted in January of 2011, and US patent protection is in process. Additional patent applications have been filed worldwide.
SAMi’s corporate objective is to bring this promising therapy to patients worldwide who suffer from various obstructive lung diseases, including asthma and chronic obstructive pulmonary disease (COPD), among others. The company anticipates this treatment will open airways that current rescue therapies don’t open, will help dislodge and clear mucous plugs, and will act synergistically with the current standard of care therapies to make them more efficacious.
SAMi is lead by Chief Executive Officer Dr. John Dennis, a recognized expert in medical aerosol science and a contributor to the company’s efforts since 2005. Dr. Francis Green, a pathologist at the University of Calgary and one of the scientific founders, serves as the Chief Scientific Officer and leads the company’s research affairs. Gareth Lewis, a MBA grad with accounting credentials rounds out the SolAeroMed managment team as Chief Financial Officer.
SAMi management has been successful in attracting highly knowledgeable and experienced professionals to the Board of Directors. On the Board are Andy Clark, Site Head and Chief Technology Officer (San Carlos) of Novartis Pharma AG, Gwyn Humphreys, CEO of Evocutis and formerly the Managing Partner of Bradford Particle Design up until its successful sale to Nektar Therapeutics, and Ian McAffer, formerly Managing Director of Breath plc up until its successful sale to Watson Pharmaceuticals as part of the Arrow Group. Also serving on the Board are Mr. Michael Flach, a corporate lawyer, Dr. Dennis and Dr. Green. Recent addition of Phyllis Kane, and experienced executive, rounds out our board number to 7 persons.
There are several potential indications in the treatment of obstructive lung disease for SAMi’s lead product S-1226, an inhaled therapy of neat perflubron nebulized with carbon dioxide enriched medical air. These include (1) in the emergency department (ED) and paramedic setting, (2) as a personal portable rescue device, and (3) as a synergistic enhancer of efficacy in combination with other therapies. The disorders indicated include asthma, COPD, and cystic fibrosis.
Acute airway constriction, characterized by rapidly constricted airways and mucus over-secretion, is a condition most prevalent in two diseases, asthma and COPD. In aggregate, these two conditions affect over 41 million people in the US alone (2009 figures). This is an increasing number and projections indicate that there will be over 43 million Asthma/COPD sufferers in the US by 2013.
The main therapies for obstructive respiratory diseases are anti-inflammatory drugs and bronchodilators, or combinations thereof. Although these treatments are effective for maintenance of the majority of cases, there are three main reasons why they may become less than optimally effective or even fail completely. First, in extreme cases the airways may become too obstructed by mucous plugs for proper dispersion of the medication to the affected areas. Second, patients may become less responsive to bronchodilator medication due to desensitization. Third, there is a subset of patients who respond poorly to anti-inflammatory medication.
There is a significant unmet medical need for a new treatment for obstructive respiratory disorders such as asthma and COPD that is a) rapid enough to rescue patients within a short treatment window, b) effective through non-adrenergic pathways to treat patients refractory to conventional treatments, and c) easy to deploy by emergency medical workers, in the ED, and by patients at home.
SAMi has chosen treatment of acute asthma in the hospital setting as the lead indication as it is anticipated that this setting will make clinical studies easier and faster and cheaper to perform, be safer for patients, encounter lower regulatory hurdles, and require only a modest number of subjects for clinical trials.
S-1226 aims to complement rather than replace current treatments. It is intended to be deployed when conventional bronchodilators lose their effectiveness. SAMi has demonstrated that S-1226 does not require β-adrenergic pathways to dilate airways, thus S-1226 and salbutamol, the primary component of current front line therapy, act through different mechanism. SAMi’s expectation for the eventual utilization of S-1226 is as an addition to the current standard of care. In the ED, co-treatment with S-1226 is anticipated to provide predictable, rapid relief, reduced morbidity and recovery time through which we can demonstrate significant pharmaco-economic advantages.
SAMi has completed initial efficacy studies in two animal models (sheep and rat) that demonstrate the potent bronchodilatory effect of S-1226. A CTA was filed with Health Canada in February 2013 and clearance was obtained to proceed to clinical trials.
Our Phase I demonstrating saftey of S1226(8%) was comleted in Q2 2014. Our The next trial, a Phase IIa study, will examine in a single site in-patient clinic setting the safety and efficacy of S-1226 provided to mild asthmatics with allergen-induced bronchoconstriction. The Phase IIa is anticiapted to start Q4 2014. This trial is anticiapted to be followed by an Emergency Department -setting adaptive Phase IIb trial assessing S-1226 in mild, and later, severe, acute asthma patients. The Phase IIb study is being contemplated to compare S-1226 as a component of the standard of care against the standard of care alone. Pivotal trial design will be determined by the Phase IIb results.
Following approval for the ED setting use of S-1226, the second indication of home use, represents a much larger market opportunity, with correspondingly larger risks and costs associated with development.. Increased costs include a new proprietary delivery device, as well as the need for additional clinical studies.
SAMi has adopted a lean and efficient approach to raising and utilizing capital to fund its activities. To date all personnel are either working for equity or are paid for by non-dilutive (grant) funding, or a combination thereof. Other costs (research, consultants, materiel, lab/office space, office supplies) are subsidized 80-90% through Canadian government funding. The company intends to maintain this strategy, although eventually costs will rise as specialized and needed members are added to the management team, increased patent work, and clinical studies, for which no non-dilutive funding is available..
SAMi is raising finance as needed to advance the company through its next significant regulatory milestones; completion of the Phase IIa and expansion of our IP portfolio. Curent share price is $5 with some 2.1MM shares outstanding and an overall valuation near $11 million.
Following successful Phase IIa results, we plan to either partnership/license our S1226 technology or raise a $3-6MM tranche to fund the Phase IIb.
SAMi management believes that the potential for acquisition by a large pharmaceutical company following successful Phase I, IIa, or IIb results represents a compelling exit opportunity for shareholders, with an alternative exit of public listing.
A detailed Business Development and Investor presentation is available on request, and relevant questions on our company details or direction should be directed to SolAeroMed CEO in the 1st instance.