Lpath, Inc., the Category Leader of Lipidomics-Based Therapeutics, Provides Status Update and Outlines Near-Term Goals

SAN DIEGO, CA--(Marketwire - August 05, 2010) - Lpath, Inc. (OTCBB: LPTN), the category leader in lipidomics-based therapeutics, issued a status update today, along with an outline of its key near-term business goals, which management will discuss on a teleconference call at 1:00 p.m. ET today (see call instructions, below).

Management will discuss the following near-term goals:

A. Near-Term Goals Related to iSONEP™ Drug Development Program for Ocular Indications

• Submit plans for subsequent clinical trials to the FDA by end of 2010. Thus far, Lpath has nearly completed the protocol development of:
  
  1. A 20-patient Phase 1b/2a trial in patients with RPE Detachment, a persistent complication in patients with the occult form of Wet AMD. Of the 15 patients in the Phase 1 iSONEP trial, two patients were diagnosed with RPE Detachment. With only a single dose of iSONEP, both of these patients experienced complete resolution of the condition -- neither Lucentis® nor Avastin® produces this type of clinical benefit with a single dose (typically, they will not resolve the condition with 12 or more monthly injections). There is currently no approved treatment for RPE Detachments.
  
  2. A larger Phase 1a/2b trial in Wet-AMD patients with some form of occult disease. In the Phase I iSONEP trial, all of the patients with a component of occult disease exhibited a strong positive biological effect during the 30-45 days following a single injection of iSONEP, and two of them were not re-treated with anything for more than a year following iSONEP treatment.
  
  
• Start dosing patients early in 2011.
  
  
• Consider licensing out certain rights to iSONEP. The iSONEP program has attracted considerable attention from global players and regional players alike, including a non-binding letter of intent. Lpath is continuing to pursue discussions and a potential transaction with such players.
  
  

B. Near-Term Goals for ASONEP™ Drug Development Program for Cancer

• Re-partner the ASONEP program. Discussions continue with several potential partners regarding licensing rights to ASONEP, and the company is pursuing a term sheet for a potential transaction.
  
  
• Evaluate the possibility of conducting Phase 2 clinical trials with academic groups that have demonstrated strong efficacy results in nonclinical studies. In a presentation at the American Association for Cancer Research in 2009, Rupal Bhatt, M.D., Ph.D. of the Beth Israel Deaconess Medical Center (a major Harvard Medical School affiliate) demonstrated that the murine (or mouse) version of ASONEP, as a single agent in naïve mice, significantly delays progression of disease in Renal Cell Carcinoma ("RCC"). Dr. Bhatt also presented evidence suggesting ASONEP could thwart resistance to TKI therapy: Nearly all RCC patients treated with TKI develop resistance and experience renewed progression of disease with a "mean time to disease progression" of 1.9 months after initiation of TKI treatment. Moreover, agents approved for dosing after TKI-therapy failure add only two months of progression-free survival. As such, there is a great unmet need for agents that will delay progression of renal cell cancer for longer durations of time. According to Bhatt, "Lpath's ASONEP, which neutralizes a tumorigenic pathway that is quite distinct from the VEGF pathway, holds promise to further delay disease progression."
  
  
• Lpath is currently working with Harvard Medical School on plans to conduct one or more clinical trials and with the University of Toulouse on a possible Phase II trial. Such trials would begin in 2011.
  
  

C. Near-Term Goals Related to Lpathomab™ Drug Development Program

• Partner the Lpathomab Program. Presently, Lpath is pursuing discussions with two global pharmaceutical companies regarding the out-license of rights to Lpathomab. Both companies are currently conducting confirmatory animal studies.

D. Near-Term 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. Lpath recently selected its next bioactive-lipid target and was successful in generating antibodies against the target. The company is now assessing performance of the various antibody candidates. The strategy for ImmuneY2 is to continue to feed the development pipeline with novel antibodies that have strong intellectual property positions, similar to the approach with the company's anti-S1P and anti-LPA programs.

E. Q2 2010 Financial Update

• As of June 30, 2010, Lpath's cash position totaled $4.9 million. Additional near-term sources of cash include: (i) the recently-awarded $3 million BRDG-SPAN grant from the National Eye Institute (part of NIH) to support iSONEP-related trials; (ii) the three year, $3 million BRDG award from NIH received last year that still has two years and $2 million remaining for the funding of ASONEP clinical trials; and (iii) the IRS Therapeutic Discovery Program, which could result in a multi-million-dollar award for Lpath (results to be announced end of October). In all, Lpath will likely have access to $10-12 million -- excluding any monies derived from partnerships -- to execute its plan over the next three years.
  
  
• As mentioned above, Lpath has made great strides in advancing discussions with various potential strategic partners. These licensing opportunities could significantly enhance Lpath's financial position.
  
  

Scott R. Pancoast, Lpath president and CEO, commented, "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 term."

Conference Call
Lpath will hold a conference call later today, Thursday, August 5, 2010 at 1:00 p.m. Eastern time, to discuss this status update and the company's near-term goals. Lpath President and CEO Scott Pancoast will host the presentation, followed by a question-and-answer period.

To participate in the call, dial the conference number 5-10 minutes prior to the start time and provide the conference ID provided below.

Dial-In Number: 1-800-895-0198
International: 1-785-424-1053
Conference ID#: 7LPATH0805

Internet simulcast and replay: http://viavid.net/dce.aspx?sid=00007939

If you have any difficulty connecting with the conference call, please contact Liolios Group at 1-949-574-3860.

A telephone replay of the call will be available from 3:00 p.m. Eastern time on the same day until August 12, 2010 by dialing one of the following numbers and entering the passcode:

Toll-free replay number: 1-877-870-5176
International replay number: 1-858-384-5517
Passcode: 12021

About Lpath
San Diego-based Lpath, a therapeutic antibody company, is the category leader in lipidomics-based therapeutics, an emerging field of medicine that targets bioactive signaling lipids for treating a wide range of human disease. Lpath's ImmuneY2™ drug-discovery engine has the unique ability to generate therapeutic antibodies that bind to and inhibit bioactive lipids that contribute to disease. The company is currently advancing three drug candidates, two of which -- ASONEP™ for cancer and iSONEP™ for wet AMD -- have completed Phase I clinical trials and will soon begin Phase II trials. For more information, go to www.Lpath.com.

About Forward-Looking Statements
The Company cautions you that the statements included in this press release that are not a description of historical facts are forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934. Such forward-looking statements may be identified by words such as "believe," "intend," "expect," "may," "could," "would," "will," "should," "plan," "project," "contemplate," "anticipate," or similar statements. These include, but are not limited to, statements regarding: the Company's interpretation of the results of its Phase 1 clinical trial for iSONEP; the potential biological effects and indications for use of iSONEP; the interpretation of nonclinical results of ASONEP; the Company's ability to complete additional discover and development activities for drug candidates utilizing its proprietary ImmuneY2 drug discovery process; the Company's likelihood of receiving a term sheet or completing an out-licensing transaction for any of its drug programs; the Company's likelihood of receiving an award from the IRS Therapeutic Discovery Program. Actual results may differ materially from those set forth in this press release due to the risks and uncertainties inherent in the Company's business, including, without limitation: the design of future clinical studies may change due to various risks associated with the regulatory process; the timeline of any future clinical trials may slip due to regulatory hurdles, financial difficulties, or failure to execute; the results of any future clinical trials for iSONEP and ASONEP may not be favorable; the Company may never receive regulatory approval for any of its drug candidates; the Company's discussions may not result in the receipt of term sheets and the Company may fail to forge any partnerships; and the Company may fail to secure the funds necessary to support its product development plans. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company's filings with the Securities and Exchange Commission, including its Annual Report on Form 10-K and its Quarterly Reports on Form 10-Q filed with the SEC. Such documents may be read free of charge on the SEC's web site at www.sec.gov. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement and the Company undertakes no obligation to revise or update this press release to reflect events or circumstances after the date hereof. This caution is made under the safe harbor provisions of Section 21E of the Private Securities Litigation Reform Act of 1995.