lpath inc-class a (LPTN) Key Developments
Lpath Inc. Announces Plan to Begin Lpathomab Clinical Trial
Jul 23 15
Lpath Inc. announced that the U.S. Food and Drug Administration (FDA) has completed its review of the Investigational New Drug Application (IND) for Lpathomab. The FDA informed the company that the Phase 1 clinical trial to study Lpathomab may now be initiated. Lpath plans to begin this trial upon investigational review board approvals and anticipates the first subject to be dosed within two months.
Lpath, Inc. Receives Non-Compliance Notice From NASDAQ
Jul 14 15
On July 9, 2015, Lpath, Inc. received a notice letter from the Listing Qualifications Staff of The NASDAQ Stock Market LLC indicating that, based upon the closing bid price of the company’s common stock for the last 30 consecutive business days, the company no longer meets the requirement to maintain a minimum bid price of $1 per share, as set forth in Nasdaq Listing Rule 5550(a)(2). In accordance with Nasdaq Listing Rule 5810(c)(3)(A), Nasdaq will provide the company with a period of 180 calendar days, or until January 5, 2016, in which to regain compliance. In order to regain compliance with the minimum bid price requirement, the closing bid price of the company’s common stock must be at least $1 per share for a minimum of ten consecutive business days during this 180-day period. In the event that the company does not regain compliance within this 180-day period, the company may be eligible to seek an additional compliance period of 180 calendar days if it meets the continued listing requirement for market value of publicly held shares and all other initial listing standards for the Nasdaq Capital Market, with the exception of the bid price requirement, and provides written notice to Nasdaq of its intent to cure the deficiency during this second compliance period, by effecting a reverse stock split, if necessary. However, if it appears to the Nasdaq Staff that the company will not be able to cure the deficiency, or if the company is otherwise not eligible, Nasdaq will provide notice to the company that its common stock will be subject to delisting. The Notice does not result in the immediate delisting of the company’s common stock from the Nasdaq Capital Market. The company will continue to monitor the closing bid price of its common stock over the 180-day period to see if its closing bid price may increase based on its future filings with the Securities and Exchange Commission or any future announcements the company may be able to issue regarding its drug development programs and plans. The company will also consider its available options to regain compliance, including effecting a reverse stock split, which would be subject to the prior approval of the company’s stockholders. There can be no assurance that the company will be able to regain compliance with the minimum bid price requirement or maintain compliance with the other listing requirements necessary for company to maintain the listing of its common stock on the Nasdaq Capital Market.
Lpath Reports Results for iSONEP™ in Patients with Wet Age-related Macular Degeneration
May 20 15
Lpath Inc. announced that its 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. Wet AMD patients who had not responded adequately to existing anti-vascular endothelial growth factor (VEGF) therapies including Lucentis®, Avastin® and Eylea® did not show any statistically significant improvement in visual acuity when treated with iSONEP as an adjunctive or monotherapy. Nexus is a prospective, randomized, double-masked, positive control, Phase 2 clinical trial conducted in the U.S. that enrolled 158 patients with wet AMD. All enrolled patients had been subresponsive to treatment with anti-VEGF drugs, and had received at least three previous injections of an anti-VEGF drug. Nexus study patients each received four intravitreal injections over the 90 day dosing period. There were approximately 39 patients in each of the four treatment arms. The pre-specified primary endpoint of the study was mean change in best corrected visual acuity (BCVA) by Early Treatment Diabetic Retinopathy Study (ETDRS) from Day 0 to Day 120. At day 120, patients who received intravitreal injections of (i) 4.0 mg iSONEP alone lost a mean of 3.17 letters on the ETDRS, (ii) a combination of 0.5 mg iSONEP and anti-VEGF therapy gained a mean of 4.22 letters, (iii) a combination of 4.0 mg iSONEP and anti-VEGF therapy gained a mean of 3.63 letters, and (iv) an anti-VEGF therapy alone gained a mean of 4.34 letters. Full study results will be presented during the Retina Subspecialty Days in conjunction with the American Academy of Ophthalmology in Las Vegas, Nevada in November 2015.
Lpath Inc., Annual General Meeting, Jun 16, 2015
Apr 27 15
Lpath Inc., Annual General Meeting, Jun 16, 2015., at 09:00 Pacific Standard Time. Location: 4025 Sorrento Valley Blvd. Agenda: To elect five directors to hold office until the next annual meeting and until their respective successors are elected and qualified; to ratify the appointment of Moss Adams LLP as independent registered public accounting firm for the fiscal year ending December 31, 2015; to hold a non-binding advisory vote on the compensation of named executive officers; to approve an amendment to amended and restated 2005 equity incentive plan which, among other changes described in Proxy Statement, increases the number of shares of common stock issuable under the plan by 1,700,000 shares; and to transact such other business as may properly be brought before the meeting or any adjournment or postponement thereof.
Lpath Inc. - Shareholder/Analyst Call
Mar 23 15
To update investors on the progress of Lpath's programs