Accomplishments

From the very beginning, MacuCLEAR’s prize-winning business plan has been intended as a strategic overview for the direction of the company’s growth and technology development. It is also intended to be a dynamic document, updated and adjusted to reflect actual events. Here are some of our recent accomplishments:

  • MacuCLEAR is raising $6M+ to fund its next phase of clinical trials. Angel, VC, and institutional money sources are being contacted. The Texas A&M College of Medicine Foundation has created a funding mechanism for high net worth individuals to make a tax deductible donation, or foundations, needing to comply with their foundation status can make a donation to this foundation, which will be directed to the Institute of Ocular Medicine, a 501 c 3 organization, which is engaged with MacuCLEAR for its clinical development.
  • MacuCLEAR received a $245K grant at the end of October from the IRS/HHS for having a qualifying therapeutic development project that addressed an umet need that has no approved treatment.
  • MacuCLEAR led by, Fred Cole, Jr., one of its preferred shareholders, raised nearly $700K at $12.00/share in October 2010. This exceeded the $500K of new money required by the State of Texas to set the price of the warrants it held when it gave MacuCLEAR $1.7M as part of its Emerging Technology Fund in 2009.
  • MacuCLEAR received an acquistion offer in March of 2010 at a substantial valuation and a commitment to fund its clinical program. After careful due diligence and failure of the suitor to meet its milestones, Management and MacuCLEAR's shareholders rejected this offer.
  • MacuCLEAR successfully completed its novel Phase Ib/POC human clinical trial in the Fall of 2009, which proved its lead drug MC-1101 is safe and well tolerated, as well as proving it gets to the back of the eye in the macular area, and improves blood flow in the choroid following topical administration.
  • MacuCLEAR successfully opened the IND for MC-1101 with FDA in October, 2008 giving it clearance to begin human clinical trials.
  • The FDA formally granted MC-1101 Fast Track status
  • The State of Texas Emerging Technology Fund has approved MacuCLEAR for $1.7M to conduct a Phase I Clinical Trial
  • MacuCLEAR and Mystic Pharmaceutical, Inc. have entered into a collaborative agreement to use Mystic's novel eyedrop device.

Other accomplishments since our Company’s founding in the fall of 2006 include:

  • MacuCLEAR completed its initial series A preferred stock funding on April 17, 2007, exceeding the business plan objective for funding. Investors constitute experienced life science oriented private investor groups.
  • MacuCLEAR named its board of directors with five members, including CEO Phil Ralston; CSO Dr. George Chiou; Vice Chancellor for Technology Transfer from Texas A&M, Guy Diedrich; the lead investor, David Nelson, JD; and Dennis McWilliams, CEO, Apollo Endosurgery.
  • MacuCLEAR entered into a sponsored research agreement in June, 2007, with the Texas A&M Research Foundation for the next two years to cover the pharmacodynamic work related to formulation development of our technology. This work conducted under the direction of Dr. George Chiou, the inventor of MC1101, has resulted in two effective dose forms and demonstrated efficacy in animal models to date.
  • MacuCLEAR successfully completed the preclinical formulation and stability work related to finalizing the topical formulation of MC1101 that is intended to be used in our human clinical program. This has resulted in at least two formulations that show manufacturability and three-month stability so far. A two year, real-time stability study has been initiated to comply with anticipated FDA requirements. This work has been completed under budget and ahead of schedule.
  • MacuCLEAR has successfully completed a pre-IND meeting with the FDA.  It accomplished this goal on less than half of its initial funding and two months ahead of schedule. It expects to remain on schedule to be in human clinical trials in the first quarter of 2009.
  • MacuCLEAR has filed for PCT patent coverage in Europe, Canada, Australia and Japan. It has received a German Utility certificate in second quarter 2008. First office action from the U.S. Patent Office is expected spring 2009. MacuCLEAR’s freedom to operate and patentability have been reconfirmed with patent counsel in 2008.

Management believes MacuCLEAR is effectively following its business plan and accomplishing its strategic objectives. We will continue to strive to operate on time and to budget. We welcome any questions or comments.