As the conclusion in our research on the Sunshine Heart (SSH) we wrote: Join us on Sunshine Heart's board before mainstream media blows this stock up.
SSH stock accomplished a remarkable run-up in just three trading session. SSH shares were tripled in price and only now, week later and Sunshine Heart’s stock retracements back for 30%, the mass media started to cover it.
Point is: be proactive, follow our research, and your account will boost in value on the upcoming market reaction for our new undervalued investment opportunity pick - Lpath, Inc. (LPTN)
1. Company and its products:
Lpath Incorporated 4025 Sorrento Valley Blvd. San Diego, CA 92121 Tel: 858-678-0800 Fax: 858-678-0900 http://www.lpath.com/
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.
In this report we’d like to highlight Lpath’s iSONEP™ product candidate for the treatment of the wet Age-related Macular Degeneration (AMD). Over 1.5 million Americans affected with this disease. At present time only drugs such as Lucentis® or Avastin® are available for the treatment. Medications are very expensive and required to be taken on a daily basis. Just imaging how inconvenient for the wet AMD patient to carry everywhere a container (drug must be kept at the particular temperature) with the daily medication quantity. Moreover, the existing wet AMD drugs have serious side effects. For instance, the Lucentis® patients may have serious infections inside the eye, detached retinas, and cataracts. The most common non–eye-related side effects are nose and throat infections, headache, and respiratory (lung) infections. Although not common, Lucentis® patients have had eye- and non–eye-related blood clots (heart attacks, strokes, and death). Even more, if children affected with wet AMD still have a chance to recover from this disease when their body develops an immune protection at the age of 18th or so, adults must take those medications for the entire life.
Lpath’s iSONEP™ is not only reduced the medication dose from the daily to once per week, not only eliminate the drug-related serious adverse events, but it also succeeded in a key positive biological effects. Will iSONEP™ be a cure for the wet AMD? Continuation of the iSONEP™ Phase II and subsequent studies will be answering to this question.
2. Series of Unfortunate Events
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.
3. Time is NOW
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. [...]
Currently available drugs Lucentis and Avastin, owned by Genentech of the Roche Group (RHHBY.PK), only treat the symptoms over an effective 30 - 60 days. iSONEP is much closer to a CURE, as evidenced by past studies. In the Phase I trial, the candidate met primary endpoints for tolerance and also indicated an ability to mitigate retinal thickness and regress lesion, among other significant biological effects. In 2 of the 15 patients, RPE detachment was completely resolved. Average reduction of the faucet was 76% - far better than what Lucentis and Avastin have shown.
What is critically important is that most drugs ONLY control symptoms. You name it appetite suppressants, cardiovascular drugs, anti cholesterol drugs, tranquilizers. most cancer drugs etc,etc, only control symptoms.
The fact that iSONEP in 2 of the 15 patients, RPE detachment was completely resolved is outstanding by any means of measurement and a critical advantage as iSONEP progresses to phase 11 .
FDA Fast track is a process designed to facilitate the development, and expedite the review of drugs to treat serious diseases and fill an unmet medical need. The purpose is to get important new drugs to the patient earlier. Fast Track addresses a broad range of serious diseases. Determining whether a disease is serious is a matter of judgment, but generally is based on whether the drug will have an impact on such factors as survival, day-to-day functioning, or the likelihood that the disease, if left untreated, will progress from a less severe condition to a more serious one.
If iSONEP would come to market think fast track. I know thats what Pfizer and most longs on this board are thinking.