Category Leader Lpath, Inc. Establishes Key 2009 Goals

SAN DIEGO, CA--(Marketwire - February 11, 2009) - Lpath, Inc. (OTCBB: LPTN) will report its key 2009 business goals and objectives as established by management and approved by its board of directors. The business goals and objectives, detailed below, will be discussed in a teleconference call and simultaneous webcast hosted by Lpath management today at 11:30AM EST. To participate in the teleconference, please call toll-free 877-407-9210 (direct dial 201-689-8049) five minutes before the scheduled start in order to register for the call. The call is also accessible on the internet at http://www.investorcalendar.com/IC/CEPage.asp?ID=140640. A replay will be available at www.Lpath.com or by telephone for one week by dialing 877-660-6853 and entering Account Number 286 and Conference ID Number 312160.

A. 2009 Goals Related to ASONEP™ Drug Development Program for Cancer

-- Conduct a successful Phase 1 clinical trial in cancer patients: The Phase 1 clinical trial of ASONEP is proceeding as expected: Dosing of patients at the third dose level (10mg/kg) is nearly complete, and ASONEP has been well tolerated to this point. Merck-Serono, which has an exclusive worldwide license from Lpath for ASONEP, has established four objectives for the Phase 1 portion of the development program: (1) demonstrate safety and tolerability of ASONEP at reasonably high doses in a 13-week monkey study; (2) optimize manufacturing yields to commercially acceptable levels; (3) demonstrate commercially reasonable half-life of ASONEP in humans; and (4) demonstrate dose-dependent biological activity of ASONEP in humans. Lpath receives $2.0 million from Merck-Serono for achievement of each of these four objectives. -- Receive $28.0 million Phase 2 milestone commitment from Merck-Serono: If Merck-Serono deems Lpath’s Phase 1 successful (as defined generally by the four objectives listed above), they will commit to a $28 million milestone payment and take over the ASONEP clinical program, including all Phase 2-related costs. 

B. 2009 Goals Related to iSONEP™ Drug Development Program for Ocular Indications

-- Complete the iSONEP Phase 1 clinical trial and determine the Phase 2 dose: Thus far, iSONEP has been well tolerated at all three dose levels tested, out of five dose levels ranging from 0.2 mg per eye to 1.8 mg per eye. Lpath expects to establish a Phase 2 dose level by the third quarter of 2009. -- Select the best Phase 2 indication(s) for iSONEP: Lpath has many ways to win within the wet AMD indication: first line, second line (for refractory Lucentis®/Avastin® patients), and combined therapy with these anti-VEGF compounds. In addition, because of iSONEP’s unique combination of mechanisms, iSONEP holds great promise for the treatment of diabetic retinopathy and possibly dry AMD, representing two of the largest unmet medical needs in ophthalmology today. Other possible indications include Proliferative Vitreo-Retinopathy (PVR), glaucoma-related surgeries, and various anterior-segment diseases. Besides carefully monitoring hints of efficacy that might surface in its Phase 1 trial, Lpath will also conduct various other studies to determine which indications are good bets for Phase 2 indications. 

C. 2009 Goals Related to Lpathomab™ Drug Development Program

-- Move forward with the selected “lead": Late in 2008, in the ordinary course of evaluating the lead Lpathomab compound in various models of cancer and fibrosis, Lpath determined that a second version of the anti-LPA antibody was also demonstrating strong levels of efficacy. As such, Lpath is humanizing this second candidate and will test it head-to-head with the first to determine which of the two candidates to move into the clinic. Depending on which one is chosen, Lpath will file an IND either in Q2 or Q4 of 2010. 

D. 2009 Goals Related to Lpath’s ImmuneY2™ Platform Technology

-- Leverage Lpath’s ImmuneY2™ drug-discovery engine by generating additional monoclonal antibodies against novel bioactive-lipid targets: The company has chosen three additional bioactive-lipid targets and expects to generate several new antibody candidates this year. We also plan to work more closely with various academic entities that can act as a “farm system” for additional bioactive-lipids that hold great promise as targets. 

E. Other Key 2009 Goals

-- Push for additional partnerships: Lpath hopes to plant many seeds for partnering during 2009. Just as the company waited for the right partner and the appropriate partnering terms with its ASONEP program, Lpath will do the same with other partnering opportunities. Given the breadth and depth of Lpath’s ImmuneY2 drug discovery engine, the company could potentially be involved in numerous partnerships that leverage this technology. -- Improve infrastructure: Lpath establishes a number of objectives each year relating to controls and teamwork that reflect the evolutionary needs of a growing and maturing company. Specific 2009 objectives in this area include: passing all the relevant Sarbanes-Oxley compliance tests, enhancing various SOPs, and improving various training programs. 

“Lpath has maintained a strong record of achieving its stated goals and hitting major milestones,” said Scott R. Pancoast, Lpath president and CEO. “We continue to make progress on all fronts, and will continue to balance growth and cash burn in an effort to serve our shareholders’ best interests over the long run.”

About Lpath

Lpath, Inc., headquartered in San Diego, is the category leader in bioactive-lipid-targeted therapeutics, an emerging field of medical science whereby bioactive signaling lipids are targeted for treating important human diseases. ASONEP™, an antibody against Sphingosine-1-Phosphate (S1P), is currently in a Phase 1 clinical trial in cancer and also holds promise against multiple sclerosis and various other disorders. ASONEP is being developed with the support of partner Merck-Serono as part of a worldwide exclusive license. A second product candidate, iSONEP™ (the ocular formulation of the S1P antibody), has demonstrated superior results in various preclinical models of age-related macular degeneration (AMD) and retinopathy and is in a Phase 1 clinical trial in wet-AMD patients. Lpath’s third product candidate, Lpathomab™, is an antibody against Lysophosphatidic Acid (LPA), a key bioactive lipid that has been long recognized as a valid disease target (cancer, neuropathic pain, fibrosis). The company’s unique ability to generate novel antibodies against bioactive lipids is based on its ImmuneY2™ drug-discovery engine, which the company is leveraging as a means to expand its pipeline. Please visit www.Lpath.com.

About Forward-Looking Statements:

Except for statements of historical fact, the matters discussed in this press release are forward looking and reflect numerous assumptions and involve a variety of risks and uncertainties, many of which are beyond our control and may cause actual results to differ materially from stated expectations. For example, there can be no assurance that results will be timely, necessary regulatory approvals will be obtained, the proposed treatments will prove to be safe or effective, or required clinical trials will be ultimately successful. Actual results may also differ substantially from those described in or contemplated by this press release due to risks and uncertainties that exist in our operations and business environment, including, without limitation, our limited experience in the development of therapeutic drugs, our dependence upon proprietary technology, our history of operating losses and accumulated deficits, our reliance on research grants, current and future competition, and other risks described from time to time in our filings with the Securities and Exchange Commission. We undertake no obligation to release publicly the results of any revisions to these forward-looking statements to reflect events or circumstances arising after the date hereof.