UncategorizedST-101 Announcement

May 16, 2018

Stuart Therapeutics, Inc. (Stuart), a pre-clinical stage company developing advanced ophthalmic therapeutics, announced today that it has completed the acquisition of the intellectual property rights to a patented bioresorbable drug delivery insert that is designed for both anterior and posterior segment ophthalmic diseases. The technology, designated ST-101 by Stuart, is being evaluated for its ability to treat conditions such as glaucoma, wet age-related macular degeneration, and retinitis. Stuart has negotiated an exclusive license to this technology.

ST-101 is a small wafer that is inserted subconjunctivally and which is being evaluated by Stuart as a means to deliver medication on a sustained basis for up to eight months. This sustained release approach may be ideal for glaucoma patients, as it potentially eliminates the need for patient administered drops, and the proposed eight-month cycle of replacement for the patient matches the typical visit frequency preferred by physicians. Stuart has conducted in vivo testing of the insert in animal studies, which demonstrate the effective delivery of therapeutic levels of latanoprost to the aqueous humor in test animals. The extraocular placement of the insert in these animal studies caused no irritation or scarring.

For posterior conditions such as wet age related macular degeneration, Stuart is evaluating the safety and effectiveness of similar placement of the insert to deliver an anti-VEGF therapeutic over a multi-month period. If safe and effective, the company believes that a key advantage of ST-101 in this indication is that it would potentially avoid the necessity of intraocular injections, making it less invasive than competing alternatives, and improving patient acceptance. The sustained release feature of the insert suggests that reduced frequency of administration may be possible. Stuart has pre-clinical ex vivo data supporting the trans-scleral transmission of medication using this technology.

ST-101 has multiple potential drug delivery applications, and Stuart intends to pursue development of the technology for these additional opportunities.

“ST-101 gives Stuart an important additional tool that may be very useful in the treatment of certain ophthalmic diseases,” said Eric Schlumpf, President and CEO of Stuart Therapeutics, Inc. The original TheraCol development work has demonstrated important capabilities that we believe can be readily adapted to both anterior and posterior segment ophthalmic conditions, and potentially improve upon both the current standard of care and several therapies under development. We are pursuing supporting research for the most critical indications, and will seek development partners to further extend the reach of the product.”

About Stuart Therapeutics:

Stuart Therapeutics is a pre-clinical stage pharmaceutical company focused on the development of PolyCol, a synthetic collagen mimetic peptide therapeutic platform, and ST-101, a flexible drug delivery platform. The company is developing ophthalmologic applications for these technologies.
ST-101 is a candidate therapeutic that is in pre-clinical evaluation and that has not been approved by the U.S. Food and Drug Administration (FDA) for use in treating, preventing, curing or diagnosing any disease or disorder. Similarly, the statements contained in this Announcement have not been evaluated by the FDA, and may be considered “forward-looking statements” under applicable securities laws. Such forward-looking statements necessarily involve known and unknown risks and uncertainties, which may cause actual performance and financial results in future periods to differ materially from any projections of future performance or result expressed or implied by such forward-looking statements. Although forward-looking statements contained in this presentation are based upon what management of Stuart Therapeutics believes are reasonable assumptions, there can be no assurance that forward-looking statements will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements. Stuart Therapeutics undertakes no obligation to update forward-looking statements if circumstances or management’s estimates or opinions should change except as required by applicable securities laws. The reader is cautioned not to place undue reliance on forward-looking statements.

Stuart Therapeutics, Inc.
Email: [email protected]