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Akari Therapeutics Announces Fourth Quarter and Full Year 2017 Financial Results and Highlights Recent Clinical Progress
NEW YORK and LONDON, March 21, 2018 (GLOBE NEWSWIRE) -- Akari Therapeutics, Plc (NASDAQ:AKTX), a biopharmaceutical company focused on the development and commercialization of innovative therapeutics to treat orphan autoimmune and inflammatory diseases, today announces its financial results for the fourth quarter and full year ended December 31, 2017 and highlights progress on its clinical development programs. “We made significant progress in 2017 advancing our lead product candidate, Coversin™, across our clinical pipeline of orphan inflammatory diseases, most importantly in our Phase II trial for patients with Paroxysmal Nocturnal Hemoglobinuria (PNH) which met its primary endpoint,” commented Dr. David Horn Solomon, Chief Executive Officer of Akari Therapeutics. “With this Phase II trial now completed and the selection of the dosing regimen which is intended to be used in future clinical trials, we now look forward to the opening of the first clinical site by the end of March for our first Phase III trial of Coversin in patients with PNH using a convenient patient administered sub-cutaneous (SC) dosing.” “We believe Akari is well-positioned to move forward with its priority programs in 2018. In addition to PNH, we are focused on advancing Coversin into Phase II trials in the first half of 2018 in our other key disease targets involving both the complement and leukotriene pathways, the eye disease atopic keratoconjuntivitis (AKC) and the skin disorder bullous pemphigoid (BP), both of which are orphan indications with significant unmet need. We are also continuing our Phase II trial of Coversin in patients with aHUS, which commenced in late 2017. Additionally, we are advancing Coversin SC in a patient-convenient auto-injector pen device, and are advancing Coversin in topical eye-drops for AKC, and a long-acting formulation. Having ended 2017 with good momentum, 2018 is set to be an exciting year for the company as we work towards commercializing treatments for orphan autoimmune and inflammatory diseases." Clinical Development Programs Highlights Complement Program Paroxysmal Nocturnal Hemoglobinuria (PNH)
Atypical Hemolytic Uremic Syndrome (aHUS)
Dual C5 and Leukotriene B4 Program Atopic Keratoconjunctivitis (AKC) and Bullous Pemphigoid (BP)
Fourth Quarter and Full Year 2017 Financial Results
Guidance Based on its current cash position and operating plan, the Company expects that it has sufficient cash to fund operations into the second quarter of 2019. This estimate assumes no additional funding from new partnership agreements or debt or equity financing events. 1For the seven patients that completed the study, LDH as a multiple of ULN (xULN) was 1.4, 2.2, 2.3, 1.4, 1.3, 1.6 and 1.3 at day 28; 1.5, 2.1, 1.8, 1.5, 1.3, 1.4 and 2.2 at day 60; and 1.6, 2.4, 2.0, 1.9, 1.2, 1.5 and 2.5 at day 90. Conference Call Management will conduct a conference call at 8:30 a.m. ET today to review the Company's fourth quarter and full year 2017 financial results. The call can be accessed by dialing (844) 461-9933 or (636) 812-6633 (international), and referencing conference ID 2096211. The conference call will also be webcast live over the Internet and can be accessed on the "Events & Presentations" page under the "Investors & Media" section of the Akari Therapeutics website, www.akaritx.com, prior to the event. A replay of the webcast will be available for at least 30 days following the call at www.akaritx.com. About Akari Therapeutics Akari is a biopharmaceutical company focused on developing inhibitors of acute and chronic inflammation, specifically the complement and the eicosanoid system for the treatment of rare and orphan diseases, in particular those where the complement system or leukotrienes or both complement and leukotrienes together play a primary role in disease progression. Akari's lead drug candidate Coversin™ is a C5 complement inhibitor currently being evaluated in paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS). In addition to its C5 inhibitory activity, Coversin independently and specifically inhibits leukotriene B4 (LTB4) activity. Akari intends to evaluate Coversin in two conditions, the skin and eye diseases bullous pemphigoid and atopic keratoconjunctivitis, where the dual action of Coversin on both C5 and LTB4 may be beneficial. Akari is also developing other tick derived proteins, including long acting versions. Cautionary Note Regarding Forward-Looking Statements Certain statements in this press release constitute “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements reflect our current views about our plans, intentions, expectations, strategies and prospects, which are based on the information currently available to us and on assumptions we have made. Although we believe that our plans, intentions, expectations, strategies and prospects as reflected in or suggested by those forward-looking statements are reasonable, we can give no assurance that the plans, intentions, expectations or strategies will be attained or achieved. Furthermore, actual results may differ materially from those described in the forward-looking statements and will be affected by a variety of risks and factors that are beyond our control. Such risks and uncertainties for our company include, but are not limited to: needs for additional capital to fund our operations, an inability or delay in obtaining required regulatory approvals for Coversin and any other product candidates, which may result in unexpected cost expenditures; risks inherent in drug development in general; uncertainties in obtaining successful clinical results for Coversin and any other product candidates and unexpected costs that may result therefrom; failure to realize any value of Coversin and any other product candidates developed and being developed in light of inherent risks and difficulties involved in successfully bringing product candidates to market; inability to develop new product candidates and support existing product candidates; the approval by the FDA and EMA and any other similar foreign regulatory authorities of other competing or superior products brought to market; risks resulting from unforeseen side effects; risk that the market for Coversin may not be as large as expected; risks associated with the putative shareholder class action and SEC requests for information; inability to obtain, maintain and enforce patents and other intellectual property rights or the unexpected costs associated with such enforcement or litigation; inability to obtain and maintain commercial manufacturing arrangements with third party manufacturers or establish commercial scale manufacturing capabilities; the inability to timely source adequate supply of our active pharmaceutical ingredients from third party manufacturers on whom the company depends; our inability to obtain additional capital on acceptable terms, or at all; unexpected cost increases and pricing pressures; uncertainties of cash flows and inability to meet working capital needs; and risks and other risk factors detailed in our public filings with the U.S. Securities and Exchange Commission, including our most recently filed Annual Report on Form 20-F and in our Report on Form 6-K filed with the SEC on October 17, 2017. Except as otherwise noted, these forward-looking statements speak only as of the date of this press release and we undertake no obligation to update or revise any of these statements to reflect events or circumstances occurring after this press release. We caution investors not to place considerable reliance on the forward-looking statements contained in this press release.
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