Lpath Inc fka LPTN

[Lone Wolf]

LPTN- Worth a ticket IMO. Book value- $.49. $11.5mil in cash. $6mil market value.

Makes this worth the speculation:

Overview



We are a biotechnology company focused on the discovery and development of lipidomic-based therapeutic antibodies, an emerging field of medical science that targets bioactive signaling lipids to treat a wide range of human diseases. We have developed four drug candidates, advancing the first two to mid-stage trials, and built evidence to support our approach of targeting bioactive lipids to treat a wide range of diseases. We currently intend to initiate a Phase 1 clinical trial for our drug candidate, Lpathomab™, in September 2015. We also intend to generate in vivo data in select programs, including Altepan™ and other earlier stage preclinical candidates, in order to identify our next clinical candidates and indications to pursue. Additionally, we intend to actively explore partnering, licensing and monetization options for our pipeline assets.



During the quarter ended June 30, 2015, we announced that our multicenter, Phase 2 “Nexus” clinical trial evaluating iSONEP™ in patients with wet age-related macular degeneration (wet AMD) did not meet its primary or key secondary endpoints. iSONEP is the ocular formulation of sonepcizumab, a humanized monoclonal antibody (“mAb”) against sphingosine-1-phosphate (“S1P”). The Wet AMD patients in the Nexus trial did not show statistically significant improvement in visual acuity when treated with iSONEP as an adjunctive or monotherapy.



We had entered into an agreement with Pfizer Inc. in December 2010, and amended it in 2012 (collectively, the “Pfizer Agreement”), that provided Pfizer with an exclusive option for a worldwide license to develop and commercialize iSONEP. As we expected and discussed in previous press releases, based on the negative results of the Nexus trial, Pfizer elected to allow its option to expire unexercised on August 9, 2015. As a result, the Pfizer Agreement terminated by its terms, and all rights that Pfizer held in the iSONEP program have reverted to Lpath. We have no plans for further development of iSONEP.



During the quarter ended March 31, 2015, we announced that our Phase 2a single-agent, open-label study of ASONEP™ did not meet the primary endpoint of statistically significant progression-free survival in patients with advanced renal cell carcinoma (RCC). ASONEP™ is the systemic formulation of sonepcizumab. To successfully meet the primary endpoint of progression-free survival, at least 20 out of 39 patients needed to be progression-free at four months of treatment. Fourteen out of 40 patients (over enrolled by one patient) were progression-free at four months. Eight of the fourteen patients were progression-free for at least six months, of which three patients remained progression-free for over 20 months. Four patients currently continue to receive weekly infusions of ASONEP. Overall, ASONEP was well-tolerated. We are now exploring other indications where ASONEP may have a better chance of success.



As part of the Pfizer Agreement, Lpath granted to Pfizer (or a third party who may acquire Pfizer’s rights) a right of first refusal for ASONEP. That right of first refusal expired on August 9, 2015, concurrently with the expiration of Pfizer’s option to acquire the license to iSONEP.



Lpathomab is a mAb against lysophosphatidic acid (“LPA”), a bioactive lipid that has been characterized in scientific literature as playing a key role in nerve injury and neuropathic pain. Published research has also demonstrated that LPA is a significant promoter of cancer-cell growth and metastasis in a broad range of tumor types, and plays a key role in pulmonary fibrosis. Preclinical studies showed strong in vivo results with Lpathomab in several different pain models, which suggest that LPA may be an attractive target across a variety of chronic pain conditions, including diabetic peripheral neuropathy, post-herpetic neuralgia, chemotherapy-induced neuropathic pain and pain associated with lumbosacral radiculopathy.



On July 23, 2015, we announced that the FDA had completed its review of the Investigational New Drug Application (IND) we submitted for Lpathomab and authorized us to initiate the Phase 1 clinical trial to study Lpathomab . We plan to begin this trial upon obtaining investigational review board approvals and anticipate that the first subject will be dosed in September 2015.



We also have a preclinical drug candidate, Altepan, that has now shown positive results in preclinical models of pulmonary fibrosis, asthma, inflammatory bowel disease, and other indications. Altepan is a monoclonal antibody targeting members of the cysteinyl leukotriene family, which are important mediators of inflammatory disorders. Altepan is ready to begin IND-enabling development activities to prepare for an IND submission to the FDA as soon as funding is available.