ALSP experienced exponential growth and progress in 2015, and we are looking forward to even greater progress in 2016. The Company made significant scientific, collaborative, drug development, key personnel and business advances.
As you can see in other parts of this website, we’ve generated and presented compelling data on Alzheimer’s disease (AD) and Traumatic Brain Injury (TBI) for many years. As we have come to understand that TBI has the potential to serve as a human model for AD and other neurodegenerative diseases, and because it has been designated an orphan indication by the FDA with no approved drugs with which to treat it, we have made the decision to make TBI our lead indication. This year, ALSP’s Scientific Advisory Board, led by Greg Hook, Ph.D., published a landmark review which presents a compelling scientific case as to why our approach of targeting cathepsin B by using derivatives of the inhibitor E64d will likely succeed in treating TBI, see attached review.
We were very pleased to announce this year that ALSP established a collaborative research agreement, funded by the Department of Defense (DOD), with Walter Reed Army Institute of Research (WRAIR), Silver Spring, MD, an internationally recognized leader in TBI research, see attached press release. This collaboration has already resulted in a scientific presentation to the Society of Neurotrauma Meeting in Santa Fe, NM, that corroborates our cathepsin B research, see attached abstract.
Working with our manufacturing partner, Norac Pharmaceuticals, Azusa, CA, we have begun manufacturing ALP-496, our lead compound that we expect to take into clinical trials in 2016. The timing of these trials is dependent on our securing the financing to support them, which I will discuss below.
We are proud to announce that COL(R) Dallas Hack, M.D., retired Director of the Combat Casualty Care Research Program, U.S. Army Medical Research and Materiel Command, Fort Detrick, MD, has enthusiastically agreed to come on board as a consultant to ALSP. While in the military, Dr. Hack initiated and shepherded a collaboration between the DOD and the FDA called the TBI Endpoints Development (TED) program, which was established to qualify surrogate markers for TBI. Some of these markers are completing clinical trials as this is being written. Dr. Hack is also currently shepherding a joint venture between the DOD and the NCAA in the area of TBI, see attached bio on COL(R) Hack.
For those of us who have been involved with ALSP for many years, it is incredibly gratifying and motivating to see the revolutionary work of our scientific founder, Prof. Vivian Hook, Ph.D., UCSD, be increasingly recognized as valid – the number of scholarly articles supporting our approach is steadily rising, and new articles are published almost weekly. Watch this website for ongoing updates.
Columbia University and University of Illinois at Chicago license
We have licensed in, on mutually favorable terms, a novel set of compounds from Columbia University and the University of Illinois at Chicago. This strengthens our position with regard to our approach as these compounds share the same targets as our own compounds and therefore may have utility in a number of CNS indications, see attached press release. We have also initiated negotiations with a company that has a separate set of proprietary compounds that appear to have significant potential for synergy with ours in treating TBI and may be effective in multiple sclerosis (MS) and other conditions of interest to us as well. In addition, we have begun discussions with yet another company about possibly out-licensing a piece of our technology for a narrow indication. This multipronged approach will characterize our strategy as we take on the challenge of tackling these insidious diseases of the brain.
On the financial front, in addition to pursuing non-dilutive financing such as government grants and contracts like the one that we recently established with the DOD, we have accepted individual investors via our convertible promissory note. We are exceedingly proud that the Board of Directors, the Scientific Advisory Board, and many of our employees, vendors and consultants have participated as early investors through the note because of their stated confidence in the strength and validity of our approach.
We have retained Hambrecht+Co to assist us in our financing efforts and ultimately plan to undertake a REG A+ underwriting, which is in essence, a small public offering with fewer associated expenses and reporting requirements. Bill Hambrecht is a true visionary who was instrumental in the financing of Intel, Genentech, Apple, and GOOGLE. He was largely responsible for the new, expanded rules for REG A+. His firm did a number of public financings for my first company, and we are honored to have his group on our team once again. We are currently undergoing the audit processes necessary for an offering.
The support of people like yourself, whose interest brings you to read this letter, will be invaluable to our success.
We are currently in negotiations with two separate entities that have expressed a desire to invest seven figure sums in a private financing round that would precede the REG A+. In parallel we continue to raise capital via the convertible note and apply for grants; we expect that either the REG A+ offering or the private round will result in the pricing of our stock and the conversion of the outstanding notes.
The coming year, 2016, promises to be an even more exciting year for us, as we look forward to initiating the first clinical trials with ALP-496.
I am profoundly grateful for your interest in what we are accomplishing and hope that you will continue to follow us here on this website as our story unfolds.
Michael D. Pierschbacher, Ph.D.
President and CEO