4025 Sorrento Valley Blvd.
San Diego, CA 92121
Lpath, Inc. is a biotechnology company focused on the discovery and development of monoclonal antibodies targeted to bioactive lipids. Lipid-based therapeutics are an emerging field of medical science whereby bioactive signaling lipids are targeted for treating important human diseases that currently lack innovative and effective medicines.
Lpath's ImmuneY2 platform contains the ability to generate therapeutic antibodies that bind to and inhibit bioactive lipids that contribute to the spreading and growth of various diseases and inflammatory/auto-immune disorders.
Lpath's lead product candidate, iSONEPTM, is currently in two clinical trials, including (i) A Phase 1b study designed to evaluate the safety and potential efficacy of iSONEP for the treatment of Pigment Epithelial Detachment (PED) in wet AMD patients; and (ii) A Phase 2 study to determine the safety and efficacy of iSONEP given alone or in combination with Lucentis® or Avastin® in subjects with wet Age-related Macular Degeneration (AMD).
In the phase I trial in wet AMD patients, iSONEP met its primary endpoint of being well tolerated in all 15 patients at dose-levels ranging from 0.2 mg. to 1.8 mg. per intravitreal injection (three patients per dose level). No drug-related serious adverse events were reported in any of the patients. iSONEP also succeeded in meeting a key secondary endpoint in that positive biological effects (including lesion regression, reduction of retinal thickness, and resolution of pigment epithelial detachment) were observed in an encouraging number of patients. Most of these positive effects appear to be largely independent of the effects seen when wet-AMD patients undergo treatment with Lucentis® or with off-label use of Avastin®, the predominant market leaders. iSONEP™ also demonstrated excellent results in various preclinical AMD models and first-in-class results in a preclinical model of diabetic retinopathy. The drug candidate exhibits anti-fibrotic and anti-inflammatory properties, which might provide comparative advantages in a variety of ocular diseases. In December 2010, Lpath announced a collaboration agreement with Pfizer Inc. for the further clinical development of iSONEP. If successful, this collaboration could result in payments up to $517.5 million plus tiered double digit royalties to Lpath (Download PDF).
Lpath's second product candidate, ASONEPTM, is a monoclonal antibody against sphingosine-1-phosphate (S1P) that has completed a phase I clinical trial in cancer patients, where it was deemed well tolerated at dose levels up to 24 mg/kg. We intend to initiate a phase 2 clinical study with ASONEP in 2012. Recent data and scientific literature also suggest that targeting S1P might also have applications in other diseases like multiple sclerosis, colitis and other inflammatory disorders.
Lpath's third product candidate, LpathomabTM is a monoclonal antibody against lysophosphatidic acid (LPA), a key bioactive lipid that has been recognized to be involved in diseases of the central nervous system (including pain, traumatic brain injury, neurodegeneration), fibrosis, ocular disease and cancer. Lpathomab has demonstrated strong preclinical activity in several animal models of these diseases, including neuropathic pain, diabetic neuropathy, traumatic brain injury, spinal cord injury, fibrosis (pulmonary and renal), and cancer.
Lpath's unique ability to generate antibodies against bioactive lipids is based on its proprietary ImmuneY2TMdrug-discovery engine. The company is currently applying the ImmuneY2™ technology to other important bioactive lipid targets, many of which are involved in important disease processes (e.g. inflammation, cancer, pain, asthma, sepsis and others) thereby adding to our pipeline of novel antibody-based drug candidates.
Lpath has a broad and deep intellectual-property position in the lysolipid signaling area, with over 100 issued or pending patents in the U.S., with corresponding international applications. Most of these patents were developed in-house using our proprietary technologies and expertise. History:
In January 2012, Lpath reported
that it has temporarily suspended dosing patients in its PEDigree and Nexus (wet AMD) trials. The company has taken this action because FDA ceased the operation of the Formatech, Inc., LPTN's fill/finish contractor, for non-compliance with FDA's current Good Manufacturing Practice (cGMP) requirements.
Lpath had to suspend its clinical trials as a precaution to ensure the continued safety of all patients. Manufacturer failure cost the Lpath and other Formatech's clients not only money, but precious time to market as well. Leo Ehrlich, Cellceutix (CTIX) CEO and one of the former Formatech's customers, commented:
The FDA invalidated our product. The manufacturing problems were not to do with our product. It's a little like throwing the baby out with the bath water.
Anyhow, suspended trials and 6 month delay for finding an alternate fill/finish contractor caused negative market reaction on the LPTH stock: share price dropped for over 30%. A subsequent stock offering (6,482,978 shares with an exercise price of $1.10/share and 208,227 warrants, that were issued to the placement agents in the offering and to Griffin Securities, Inc., with an exercise price of $0.75/share) sent Lpath's shares even further downward.
Time for the re-establishing the trials for the Lpath's drug candidates is quickly approaching the edge. Company should initiate the iSONEP™'s Phase 2 at the end of June or as late as the beginning of August 2012.
LPTN shares are deeply discounted. We're expecting the first catalysis in the share price during the next two weeks on the prospect of Phase 2 trial renewal. Nothing is holding LPTN back: from the recent public offering Lpath's development initiatives has been funded for 18+ month; rumor of the potential takeover is started to circulate again.
Pfizer (NYSE:PFE), who committed $517.5 million to develop and commercialize iSONEP™, may come out with a takeover offer at any time. Biotech giants are always looking towards emerging companies that have made substantial progress in developing high risk/high reward projects. Instead of jeopardize own independent product development, those multi-billion biopharmas are working alongside potential buyout candidates.
On any successful Lpath's outcome the Pfizer may acquire a part of the LPTN's technologies or even the entire company in the blink of the eye. Think for a minute: why to even pay half-billion dollars for the product development and share double-digit royalties from the millions in revenues after a product commercialization if the entire company may be acquired at the fraction of these costs? For the Pfizer, $170 billion Company, a few hundred millions just a pocket change…
To value iSONEP, we make several assumptions. First, we assume that the treated population only grows by a CAGR of 5.8% from 2017 to 2034. Then we consider that the average price per annual patient dosing trends from $9K to $3K over that time period as royalties hover between 10% - 16%. Adjusting for the ramp-up factor and discounting backward by 15% yields an intrinsic value of more than $670M. Morgan Joseph finds the drug candidate worth $710M on a risk-adjusted basis with a peak global sales target of $3.6B.
Lpath Inc. (LPTN) rated Buy with price target $8 by Morgan Joseph http://www.gainerstoday.com/Gains-Stock-89703-LPTN Lpath, Inc.
is a biotechnology company focused on the discovery and development of lipidomic-based therapeutics, an emerging field of medical science whereby bioactive lipids are targeted to treat human diseases. The Company?s product candidate, ASONEP, is the systemic formulation of sonepcizumab, a humanized monoclonal antibody (mAb) against sphingosine-1-phosphate (S1P). ASONEP has demonstrated compelling results in preclinical studies against multiple forms of cancers and against multiple sclerosis. The Company?s second product candidate is iSONEP, the ocular formulation of Sonepcizumab. iSONEP has demonstrated multiple mechanisms of action in ocular models of disease, including anti-angiogenesis, anti-inflammatory and anti-vascular permeability. The Company's third product candidate, Lpathomab, is a monoclonal antibody against lysophosphatidic acid (LPA). Morgan Joseph
is committed to providing timely, objective and actionable investment advice on the companies and securities we follow. Our team of equity analysts covers a growing universe of stock issues across a broad range of industry sectors. As a middle market-focused firm, our approach is not to publish research on as many companies as possible within a number of industry sectors. Rather, our research analysts distinguish themselves by zeroing in on quality companies with growth prospects or which present special situations. These companies often lack a research following. This enables our analysts to provide insight to investors in companies that are not well understood nor fairly valued. Lpath Inc. (LPTN) rated Buy with price target $6 by Aegis Capital http://finance.yahoo.com/news/equity-briefing-upgrades-downgrades-july-142101494.html
Lpath's Clinical Trials: